VIDEO CENTER

Supply Reliability

  • Video transcript

    FOOTER TEXT ONSCREEN (for entire video):

    Please see Important Safety Information in the video and full prescribing Information available at PEDIARIX.com.

    TEXT ONSCREEN:

    Why supply reliability and single manufacturing profile of PEDIARIX matters to your practice.

    DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland):

    GSK has been a proud supplier of PEDIARIX for 19 years.

    Hi, my name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I am a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist.

    This series of videos will explore the clinical, financial, and organizational benefits of using PEDIARIX and the other GSK DTaP-containing vaccines for your appropriate patients.

    Some of these attributes include schedule flexibility, the efficacy of PEDIARIX and its safety profile, and customer solutions, including cost-saving programs. In this video, we’ll look at the importance of supplier reliability to help keep your DTaP immunization routine from being disrupted.

    First, let’s take a look at the Indication for PEDIARIX.

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

    In your practice, when was the last time you experienced a vaccine supply disruption, and how did it impact your immunization routine? What happened, or what would you imagine would happen, if you experienced supply shortages or delays? How would that affect your day-to-day vaccination routine?

    Bearing those questions in mind, I’d like to explain the importance of a reliable vaccine supplier for your patients and your practice, particularly with pediatric DTaP-containing vaccines.

    Let’s first take a look at the recent history of DTaP-containing vaccine shortages in the U.S., and one global pediatric hepatitis B vaccine shortage. In the last 8 years, there have been 3 DTaP-containing vaccine shortages, ranging in duration from 365 days to 820 days.

    The first and longest DTaP shortage, a combination DTaP vaccine, began in April 2012 and was resolved July 2014.

    In this same time period, there was also a shortage of a non-combination, regular DTaP vaccine.

    The next DTaP shortage involved a combination DTaP vaccine. It began December 2015 and was resolved December 2016.

    In addition, a pediatric hepatitis B vaccine shortage, which began in August 2017, was not resolved until March of 2020.

    Now, take a moment to think about how even one of these shortages could have affected your practice or your patients. For example, what’s it like when you have to tell parents that you don’t have the vaccines needed to help protect their baby? How does it affect your staff when you give monovalent vaccines because the DTaP-containing combination vaccine that you use is out of stock?

    Let’s look at GSK and PEDIARIX in the context of these DTaP-containing vaccine shortages.

    It’s important to note that out of those 3 DTaP-containing vaccine shortages and 1 pediatric hepatitis B vaccine shortage that occurred, none involved a GSK vaccine. In fact, GSK has a history of helping health care professionals avoid disruption in their DTaP and HepB immunization routines by helping provide the US market with additional doses in times of DTaP shortages.

    During these DTaP-containing vaccine shortages and hepatitis B vaccine shortage, GSK responded by supplying millions of additional doses, specifically to help reduce the impact of market shortages.

    Let’s look at how these shortages could affect your DTaP immunization routine. The pediatric primary series calls for administration of appropriate DTaP-containing vaccines at 2, 4, and 6 months of age, so a DTaP shortage can be disruptive to completing this series in a timely manner. If vaccines are in short supply or not available, timing of subsequent vaccinations may be affected.

    Something else to consider regarding vaccine shortages is manufacturing.

    All antigenic components of GSK DTaP-containing vaccines come from the same manufacturer-GSK. This helps ensure integration of our antigen supply, allowing the flexibility to respond to DTaP needs.

    PEDIARIX was the first combination DTaP vaccine on the market, and in its 19-year history has never had a vaccine shortage.

    Beyond supply reliability, PEDIARIX supports your practice in other practical ways, with cost-savings programs such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

    We hope this video provided you a better understanding of how GSK has supported your practice as a reliable supplier of PEDIARIX. Thank you for partnering with GSK. We look forward to supplying the vaccines you need to help your patients and your practice.

    You can order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com or by contacting your GSK Sales Representative.

    For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information available at PEDIARIX.com.

    TEXT ONSCREEN:

    Avoid disruption  to your DTaP vaccination schedule—think PEDIARIX.

    Order PEDIARIX today: Call 1-866-475-8222. Visit GSKDirect.com or contact your GSK Sales Representative.

    Schedule a GSK Vaccine Business Review today to find out more about our Premium Partner program. For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report or call 1-800-822-7967.

    DR. LEN FRIEDLAND:

    Important Safety Information for PEDIARIX.

    Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria  toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.

    The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.

    The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions.

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX.

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

    In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite.

    Vaccination with PEDIARIX may not result in protection in all vaccine recipients.

    TEXT ONSCREEN:

    Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK or licensor. PDRVID200005 February 2021. Produced in USA.

Portfolio

  • Video transcript

    TEXT ONSCREEN:

    How PEDIARIX, GSK’s other DTaP-containing vaccines, and HIBERIX fit your immunization schedule

    DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland):

    Hi, I’m Len Friedland, and I’m the Vice President and Director of Scientific Affairs and Public Health for Vaccines at GSK. I’m a practicing pediatrician, fellowship-trained in pediatric emergency medicine, and a vaccine research scientist.

    Welcome to the eLecture series for PEDIARIX – a pediatric vaccine indicated for active immunization against 5 diseases.

    In this video I’ll discuss how PEDIARIX, GSK’s other DTaP-containing vaccines, and HIBERIX can be used to help maintain your vaccination routine by fitting into your pediatric vaccination schedule. 

    In this video, I’ll go over the Indications, dosing, and Important Safety Information for these products.

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

    The recommended dosing schedule for immunization with PEDIARIX consists of 3 doses at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks).

    INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 6 years of age (prior to the 7th birthday).

    Dosing schedule: The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age.

    A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

    HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to the fifth birthday).

    Before we start, let’s discuss your Hib and DTaP vaccination routine, from purchasing to administration. Specifically, think about how the vaccines you use fit into your pediatric vaccination schedule. What challenges or conflicts have come up in the past? 

    With this in mind, I’d like to show you how the GSK family of DTaP-containing vaccines and HIBERIX fit your schedule and can help you maintain a consistent vaccination routine. Let’s take a look.

    For your infant patients, GSK offers a suite of vaccines that help protect against 6 diseases.  

    PEDIARIX, the foundation of the GSK DTaP-containing vaccine family, helps protect against diphtheria, tetanus, and pertussis, as well as polio and hepatitis B. PEDIARIX also has the broadest age indication of any combination DTaP vaccine, 6 months through 6 years of age (prior to the 7th birthday).

    As DTaP booster doses, INFANRIX and KINRIX help protect against diphtheria, tetanus, and pertussis, with KINRIX providing additional protection against polio.

    And to help protect against Haemophilus influenzae type b, GSK offers HIBERIX.

    Both PEDIARIX and HIBERIX are indicated at 2, 4, and 6 months of age and are administered concomitantly. These 3 doses of PEDIARIX make up the primary immunization course for diphtheria, tetanus, pertussis, poliomyelitis, and completes the course for vaccination against HepB. INFANRIX should be administered at 15-18 months old as a DTaP booster, with HIBERIX administered concomitantly as a final 4th dose. Administered at 4 through 6 years, KINRIX completes the pediatric vaccination series for DTaP and polio.

    In summary, PEDIARIX satisfies all primary DTaP and IPV immunizations and completes the hepatitis B series. INFANRIX satisfies the first DTaP booster requirement. KINRIX fits the second DTaP booster requirement and the IPV booster requirement. As a monovalent Hib vaccine, HIBERIX allows for dosing flexibility that may better accommodate CDC guidance for catch-up than a combination DTaP/Hib vaccine. Together, these vaccines complete your pediatric vaccination schedule for diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib. The CDC prefers that vaccines doses in a DTaP series come from the same manufacturer, when possible. GSK is the sole manufacturer of all of the antigens in PEDIARIX–and a single antigen source helps ensure integration of antigen supply and flexibility to respond to your DTaP needs. With the GSK DTaP portfolio, patients can start and stay with the same DTaP antigen content as early as 6 weeks of age, up until their 7th birthday.

    When you maintain the continuity of your schedule with the GSK pediatric vaccine portfolio, you can save on your vaccines purchases. Our Premium Partner Program gives you maximum portfolio discounts, GSK’s best pricing and other contract benefits, including flexible ordering with free shipping and overnight delivery. And you’ll get the same dependable customer service you count on with GSK. 

    Contact your GSK Representative to learn more.

    I’d like to conclude by thanking you for partnering with GSK and PEDIARIX—the cornerstone of GSK’s DTaP-containing vaccine portfolio. GSK has delivered more than 75 million PEDIARIX doses since 2002, and is committed to continue helping your patients and your practice.

    Do you know about our Premium Partner Program? You can schedule a GSK Vaccines Business Review today to find out more.

    Thank you for watching this video. For more information about PEDIARIX, INFANRIX, KINRIX, and HIBERIX, please see the Important Safety Information and full Prescribing Information for these products at PEDIARIX.com.

    Do not administer PEDIARIX, INFANRIX, or KINRIX to anyone with severe allergic reactions to any component of the vaccine. Additional contraindications for PEDIARIX, INFANRIX, or KINRIX include: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines. The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of a prior vaccine containing tetanus toxoid or if adverse reactions (ie, temperature ≥105◦F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine. 

    The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions. Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX.

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Carefully consider each infant’s medical status before proceeding with vaccine administration.

    In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were pain, redness, and swelling at the injection site, fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever, and loss of appetite. Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients.

    Contraindications for HIBERIX: severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of HIBERIX. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including HIBERIX, should be based on careful consideration of the potential benefits and possible risks. Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movement. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. Prior to administration, the healthcare provider should review the patient’s immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur. Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained.

    Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of an H. influenzae type b-containing vaccine, including HIBERIX. Immunization with HIBERIX does not substitute for routine tetanus immunization. Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, sleepiness, fussiness, and restlessness. Vaccination with HIBERIX may not result in protection in all vaccine recipients.

    TEXT ONSCREEN:

    Trademarks are properties of their respective owners. ©2021 GSK or licensor. PDRVID200002 February 2021. Produced in USA.

Schedule Flexibility

  • Video transcript

    TEXT ONSCREEN:

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland):

    How a broad age indication and flexibility to catch up appropriate patients can benefit your practice and patients.

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist. Welcome to the eLecture series for PEDIARIX.

    This series of videos will explore the clinical, financial, and organizational benefits of using PEDIARIX and other GSK DTaP-containing vaccines for your appropriate patients. 

    Some of these attributes include supply reliability, the efficacy of Pediarix and its safety profile, and customer solutions, including cost-saving programs. In this video, we’ll look at the dosing window of Pediarix in comparison with the other primary series combination DTaP vaccines and we’ll see how it might help your practice and patients.

    First, let’s take a look at the Indication for PEDIARIX.

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

    Now let’s go over the recommended way you can use PEDIARIX in your practice. 

    PEDIARIX can be administered as early as 6 weeks of age, with the last dose given prior to the patient’s 7th birthday. For the primary vaccination series, PEDIARIX should be administered as an intramuscular injection at 2, 4, and 6 months of age.

    These three doses of PEDIARIX make up the primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete course for vaccination against hepatitis B. PEDIARIX is dosed at intervals of 6 to 8 weeks, preferably 8 weeks. Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.

    PEDIARIX has the broadest age indication of all primary series combination DTaP vaccines—as early as 6 weeks of age, at intervals of 6 to 8 weeks, preferably 8 weeks, up until the 7th birthday. 

    The other primary series combination DTaP vaccines are indicated until the 5th birthday. Therefore, PEDIARIX gives you flexibility to catch up those appropriate patients who fell behind schedule.

    Let’s think about how these two extra years of dosing could potentially help your patients and your practice. Have you ever encountered a situation where a patient was behind on shots?

    Even if you haven’t, take a moment to imagine you need to catch up an older patient, 5 or 6 years old, without having a combination DTaP vaccine indicated for that age in your fridge.

    How do you think a 5-year-old patient would react to getting 3 or 4 shots at each visit?

    In these situations, two more years of dosing ability with PEDIARIX can be helpful. Let’s illustrate this with an example. 

    Preston, who’s 5 years and 1 month old, is a patient whose vaccinations are delayed: apart from his HepB birth dose, he hasn’t received any vaccinations since.

    To get him caught up to the primary series for DTaP and IPV, and the full 3-dose series of Hepatitis B, he will receive his first dose of PEDIARIX at this visit, the second dose two months later, and his third and final dose two months after that. So with just three administrations of PEDIARIX, he will complete the primary series for DTaP and IPV, and the 3-dose series for Hepatitis B.

    You may be wondering why PEDIARIX has 2 more dosing years than the other combination DTaP vaccines. The answer lies in the antigens that are in PEDIARIX. All the PEDIARIX antigens, including HepB, have dosing windows that go up to the 7th birthday. In contrast, the Hib component found in the other combination DTaP vaccines is approved only until the 5th birthday, which restricts the dosing window to then. 

    Pediarix gives you flexibility to catch up those appropriate patients who fall behind schedule, up until the 7th birthday. Using a monovalent Hib vaccine with PEDIARIX gives you two more combination DTaP dosing years, when appropriate.

    Beyond schedule flexibility, PEDIARIX supports your practice in other practical ways, with cost-savings programs such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

    After watching this video, I hope you have a better understanding of the schedule flexibility PEDIARIX provides.

    Thank you for partnering with GSK. We look forward to supplying the vaccines you need to help your patients and your practice.

    Keep your practice’s well-established DTaP immunization routine running smoothly. Order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com, or by contacting your GSK Sales Representative.

    For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information at PEDIARIX.com.

    TEXT ONSCREEN:

    Choose PEDIARIX: a flexible 5-in-1 vaccine used to help maintain your immunization routine.

    Order PEDIARIX today: Call 1-866-475-8222. Visit GSKDirect.com or contact your GSK Sales Representative.

    Schedule a GSK Vaccine Business Review today to find out more about our Premium Partner program. For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report or call 1-800-822-7967.

    DR. LEN FRIEDLAND:

    Important Safety Information for PEDIARIX.

    Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria  toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.

    The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.

    The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions.

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX.

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

    In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite.

    Vaccination with PEDIARIX may not result in protection in all vaccine recipients.

    TEXT ONSCREEN:

    Pentacel is owned by Sanofi Pasteur. Vaxelis is owned by the MSP Vaccine Company. All other trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK or licensor. PDRVID200004 February 2021. Produced in USA.

Efficacy and Safety

  • Video transcript

    TEXT ONSCREEN:

    Vaccinating Against Pertussis in Your Community.

    DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland): 

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist. In this chapterized video, I will discuss the incidence of and disease background for pertussis. Then, I’ll review how to help protect appropriate patients against pertussis in your community.

    TEXT ONSCREEN:

    Why Is It Important to Vaccinate Appropriate Patients Against Pertussis?

    DR. LEN FRIEDLAND:

    Let’s begin by reflecting on the potential impact of pertussis. Have you heard about cases of pertussis in your community?

    What would you imagine has been the impact of pertussis on patients, their families, and medical practices?

    Considering these questions, let’s explore what pertussis is and why it is of concern to public health agencies such as the CDC, and to the healthcare community.

    TEXT ONSCREEN:

    CDC = Centers for Disease Control and Prevention.

    DR. LEN FRIEDLAND:

    Pertussis—also known as whooping cough—is an acute infectious disease of the respiratory tract caused by the bacterium Bordetella pertussis. Characteristically, during the paroxysmal phase the patient has bursts, or paroxysms, of numerous, rapid coughs followed by an inspiratory effort that is usually accompanied by a high-pitched whoop.

    An infant with whooping cough may sound like this:

    [Audio plays of infant with whopping cough]

    However, infants younger than 6 months may lack the respiratory strength to produce a whoop, and cough may be minimal or absent.

    These coughing fits usually last 1 to 6 weeks, but may persist up to 10 weeks or more.
    So, some people know this disease as the “100-day cough.”

    To put this length of time in perspective, signs and symptoms of uncomplicated flu typically resolve after 3 to 7 days for the majority of people.

    And, pertussis is highly communicable, as evidenced by secondary attack rates of up to 80 percent among susceptible household contacts. Note that the secondary attack rate represents the spread of disease from the initial case to close contacts within a household or family.

    The seriousness of pertussis, including persistent coughing fits for a lengthy period of time and high communicability, make it important to vaccinate against this disease.

    Pertussis is a serious, highly contagious disease which is active in the United States.

    Here you can see the cases of pertussis that were reported in the U.S. in 2019, as well as the incidence per 100,000 people. 

    TEXT ONSCREEN:

    15,662 pertussis cases in the United States, Provisional, 2019. 4.3 incidence per 100,000 people.

    DR. LEN FRIEDLAND:

    These cases are from the CDC's 2019 provisional pertussis surveillance report. Please note surveillance data have limitations, and are often incomplete. About one half of pertussis cases in 2019 among children 6 months to 6 years of age, had unknown pertussis vaccination history. Surveillance data by itself cannot be used to interpret vaccine effectiveness or assess risk, as it's often incomplete and there is no healthy comparison group.

    Let’s now move on to our next chapter, which focuses on vaccination of appropriate patients against pertussis.

    TEXT ONSCREEN:

    How Can Demonstrated Safety and Efficacy Against Pertussis Help Your Appropriate Patients and Practice?

    DR. LEN FRIEDLAND:

    Now that we’ve reviewed some background information about pertussis, let’s delve into PEDIARIX and the other GSK DTaP-containing vaccines, beginning with the Indications. . .

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday). 

    INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years of age (prior to 7th birthday).

    A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis vaccine series and the fourth dose in the inactivated poliovirus vaccine series in children aged 4 through 6 years (prior to 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

    Do not administer PEDIARIX, INFANRIX, or KINRIX to anyone with severe allergic reactions to any component of the vaccines.

    Additional contraindications for PEDIARIX, INFANRIX, or KINRIX include: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; or progressive neurologic disorders.

    In this chapter, we will continue our series of videos that explore the clinical, financial, and organizational benefits of using PEDIARIX and the other GSK DTaP-containing vaccines for your appropriate patients.

    Some of these benefits include supply reliability, schedule flexibility, and customer solutions, including cost-saving programs.

    Moving forward, we will examine how the demonstrated safety and efficacy of PEDIARIX against pertussis can help appropriate patients in your practice.

    PEDIARIX is a vaccine that includes antigens for diphtheria, tetanus, and pertussis (collectively known as DTaP); hepatitis B, and poliomyelitis.

    Please note that according to CDC, administration of 4 doses of hepatitis B vaccine is permitted when a combination vaccine containing HepB is used after the birth dose. So, PEDIARIX may indeed be used at 2, 4, and 6 months following a birth dose of hepatitis B.

    [Chart on screen: PEDIARIX Includes Antigens for DTaP, hepatitis B, and Poliomyelitis]

    Note that the DTaP antigen content of PEDIARIX is identical to that of INFANRIX. We will cover why this is important to understanding the efficacy of PEDIARIX against pertussis later in this video.

    [Chart on screen: The DTaP content of PEDIARIX is identical to that of INFARIX]

    Let’s examine the data that support the demonstrated efficacy of PEDIARIX against pertussis, and the safety profile of PEDIARIX, which has been studied in 14 safety trials worldwide.

    Note that the efficacy of PEDIARIX is based on the immunogenicity of the individual antigens compared with licensed vaccines. Serological correlates of protection exist for the diphtheria, tetanus, hepatitis B, and poliovirus components. The efficacy of the pertussis component, which does not have a well-established correlate of protection, was determined in clinical trials of INFANRIX.

    To begin, as I said, the efficacy of PEDIARIX against pertussis was determined through clinical studies of INFANRIX, which shares an identical DTaP antigen content.

    A double-blind, randomized, active Diphtheria - Tetanus controlled trial assessed the absolute protective efficacy of INFANRIX against pertussis when administered at 2, 4, and 6 months of age.

    Following completion of a 3-dose series, an 84 percent vaccine efficacy was observed against typical pertussis, defined as 21 days or more of paroxysmal cough with confirmed infection. When the definition of pertussis was expanded to include clinically milder disease, vaccine efficacy was 71 percent against any cough lasting longer than 7 days and 73 percent against any cough lasting at least 14 days.

    In an extended, unblinded follow-up period among children 3 to 6 years, the efficacy of INFANRIX against typical pertussis was 86 percent. Thus, protection against pertussis in children administered 3 doses of INFANRIX in infancy was sustained to 6 years of age.

    Note that PEDIARIX is approved for use as a 3-dose primary series, and, by itself, does not constitute a complete vaccination course for DTaP.

    With respect to clinical trials with INFANRIX, rates of injection-site reactions (pain, redness, swelling) ranged from 10 percent to 53 percent, depending on reaction and dose number, and was highest following doses 4 and 5.

    Fever was common (20 percent to 30 percent) following doses 1 through 3.

    Other common solicited adverse events reported in approximately 15 percent to 60 percent of subjects were drowsiness, irritability or fussiness, and loss of appetite, depending on event and dose number.

    A prospective efficacy trial was also conducted in Germany and employed a household contact study design.

    TEXT ONSCREEN:

    Study Design: A prospective, controlled, household contact trial of INFANRIX assessed protective efficacy against WHO-defined pertussis.*

    *21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing. WHO=World Health organization.

    DR. LEN FRIEDLAND:

    In preparation for this study, 3 doses of INFANRIX were administered at 3, 4, and 5 months of age to more than 22,000 infants.

    TEXT ONSCREEN:

    Study Design: 3 doses of INFANRIX administered at 3, 4, and 5 months of age to >22,000 infants.

    DR. LEN FRIEDLAND:

    Index cases of pertussis were identified by spontaneous presentation to a physician.

    Households with at least one additional member besides the index case who was aged 6 months through 47 months were enrolled into the efficacy study. Household contacts of index cases were monitored for incidence of pertussis by a physician who was blinded to the vaccination status of the household.

    TEXT ONSCREEN:

    Study Design: Household contacts of index cases monitored for pertussis.

    DR. LEN FRIEDLAND:

    Vaccine efficacy was calculated based on attack rates of pertussis in household contacts classified by vaccination status.

    TEXT ONSCREEN:

    Vaccine efficacy: based on attack rates of pertussis in household contacts classified by vaccination status.

    DR. LEN FRIEDLAND:

    Let’s look at the results for World Health Organization-defined typical pertussis.

    Of the 173 household contacts who had not received a pertussis vaccine, 96 of these individuals developed WHO-defined pertussis, as compared with 7 of the 112 contacts vaccinated with INFANRIX.

    Therefore, the efficacy following a three-dose series of INFANRIX was calculated to be 89 percent.

    And, when the definition of pertussis was expanded to include clinically milder disease, the efficacy of INFANRIX was

    •       67 percent against 7 or more days of any cough

    •       81 percent against 7 or more days of paroxysmal cough

    As noted earlier, in clinical trials with INFANRIX, rates of injection-site reactions (pain, redness, swelling) ranged from 10 percent to 53 percent, depending on reaction and dose number, and were highest following doses 4 and 5. Fever was common (20 percent to 30 percent) following doses 1 through 3.

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately  administered vaccines. The benefits and risks of PEDIARIX, INFANRIX, or KINRIX should be carefully considered in anyone who experienced Guillain-Barré syndrome within 6 weeks of a prior vaccine containing tetanus toxoid, or if any of the adverse reactions that are listed in the second bullet on the screen have occurred after receipt of a pertussis-containing vaccine.

    The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions.

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral profusion following syncope. 

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX.

    Apnea following intramuscular vaccination has been observed in some infants born

    prematurely. Carefully consider each infant’s medical status before proceeding with vaccine administration.

    In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were pain, redness, and swelling at the injection site, fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever and loss of appetite.

    Remember, vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients.

    We understand that choosing a vaccine that has demonstrated efficacy and safety is important for you.

    So, let’s look at the safety profile of PEDIARIX, which has been demonstrated in 14 safety trials worldwide.

    There have been 23,849 doses of PEDIARIX administered to 8,088 infants during the 14 clinical studies. The most common solicited adverse events following any dose occurring at greater than 25 percent included local injection-site reactions, namely, pain, redness, and swelling; a fever with a temperature of 100.4°F or higher, drowsiness, irritability/fussiness, and a loss of appetite.

    This established safety profile has been reinforced by a postmarketing safety surveillance study showing no statistically significant differences between PEDIARIX and historical DTaP controls with regard to seizures or medically-attended fever.

    In comparative studies, administration of PEDIARIX was associated with higher rates of fever relative to separately administered vaccines. The prevalence of fever was highest on the day of vaccination and the day following vaccination. More than 96 percent of episodes of fever resolved within the 4-day period following vaccination (that is, the period including the day of vaccination and the next 3 days).

    Now that we’ve reviewed the efficacy and safety of PEDIARIX, let’s look at another important consideration regarding DTaP combination vaccines. When possible, the CDC prefers that vaccine doses in the DTaP series come from the same manufacturer.

    With the GSK DTaP vaccine portfolio, patients can start and stay with the same DTaP antigen as early as 6 weeks of age through 6 years of age, up until the 7th birthday.

    PEDIARIX is administered for all 3 doses of the primary series, INFANRIX is administered for the 4th dose, and KINRIX is administered for the 5th and final dose.

    TEXT ONSCREEN:

    Study Design: CDC prefers that doses of DTaP vaccine in a series come from the same manufacturer. Example: HepB, DTaP, and IPV from Birth Through 6 Years of Age [chart]

    DR. LEN FRIEDLAND:

    Beyond proven efficacy and demonstrated safety, PEDIARIX supports your practice in other practical ways with cost-saving programs, such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

    We hope this video gave you a deeper understanding of the science and safety supporting the use of PEDIARIX for appropriate patients. For more information about PEDIARIX, INFANRIX and KINRIX, Please see the full Prescribing Information on www.PEDIARIX.com.

    Thank you for partnering with GSK and PEDIARIX. We look forward to supplying the vaccines you need for your patients and your practice.

    You can order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com, or by contacting your GSK Sales Representative.

    For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information at PEDIARIX.com.

    TEXT ONSCREEN:

    Established safety profile and proven efficacy against pertussis.

    Order PEDIARIX today: Call 1-866-475-8222.  Visit GSKDirect.com or contact your GSK Sales Representative.

    Schedule a GSK Vaccines Business review today to find out more about our Preferred Partner program. For more information about PEDIARIX, please see the Important Safety Information in this video and full prescribing Information at www.pediarix.com.

    You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report or call 1-800-822-7967.

    TEXT ONSCREEN:

    Trademarks are property of their respective owners. ©2021 GSK or licensor. PDRVID200003 February 2021. Produced in USA.

Nurses’ Guide to PEDIARIX

  • Video transcript

    FOOTER TEXT ONSCREEN (for entire video):

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland):

    A Guide to the Administration of PEDIARIX for Nurses.

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist. Welcome to the eLecture series for PEDIARIX.

    This series of videos will explore the clinical, financial, and organizational benefits of using PEDIARIX and the other GSK DTaP-containing vaccines for your appropriate patients.

    Some of these attributes include supply reliability, schedule flexibility, the efficacy of PEDIARIX and its safety profile, and customer solutions, including cost-savings programs.

    In this video, we’ll cover dosing, administration, and storage, as well as barcodes and CPT codes to help you better manage your PEDIARIX supply and your immunization schedule.

    First, let’s take a look at the Indication for PEDIARIX.

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

    We know your practice gets busy, and maintaining the vaccination scheduling for your pediatric patients is a top priority. GSK is here to provide solutions to help maintain the continuity of your well-established primary series DTaP immunization schedule.

    At GSK, we also understand how important it is to continue your DTaP immunization routine without interruption. As the cornerstone of GSK’s DTaP-containing vaccine portfolio since 2002, PEDIARIX is here to help maintain the continuity of your primary series DTaP immunization schedule.

    PEDIARIX can be administered as early as 6 weeks of age, with the last dose given prior to the patient’s 7th birthday. For the primary vaccination series, PEDIARIX should be administered as an intramuscular injection at 2, 4, and 6 months of age. These three doses of PEDIARIX make up the primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and completes the course of vaccination against hepatitis B.

    PEDIARIX is dosed at intervals of 6 to 8 weeks, preferably 8 weeks. Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.

    PEDIARIX comes in a convenient 0.5-milliliter color-coded, single dose prefilled syringe. To help you reduce the steps in the administration process, the syringe is prefilled with a single-unit dose, and is color coded to help with identification. Please be aware that the tip caps of the prefilled syringes of PEDIARIX contain natural rubber latex and may cause allergic reactions.

    To further help save you time and manage your vaccine supply, PEDIARIX has 2-D bar codes that contain the National Drug Code (or, NDC) number, lot number, and expiration date.

    With this additional information, you can more easily update your inventory management system, patient records, and vaccination reports through any compatible Electronic Medical Record or Electronic Health Record.

    For your convenience, all the information you need for charting is found on the carton, including the lot number, expiration date, UPC and 2-D bar codes, and the numbers for both the syringe and the outer carton. The CPT code for PEDIARIX is 90723.

    GSK wants to help simplify all aspects of the vaccination process for your practice, which is why we’ve designed our vaccine packaging with you in mind. Now that we’ve talked about the packaging, let’s go over the administration process for PEDIARIX.

    Shake PEDIARIX vigorously to obtain a homogenous, turbid, white suspension. Once mixed, attach a sterile needle to the syringe and administer the dose of PEDIARIX intramuscularly.

    For children younger than 1 year of age, the preferred administration site is the anterolateral aspect of the thigh. In older children, the deltoid muscle is usually large enough for an intramuscular injection. PEDIARIX should not be injected in the gluteal area or in areas where there may be a major nerve.

    Do not administer PEDIARIX intravenously, intradermally, or subcutaneously.

    When storing your PEDIARIX supply, be sure to refrigerate between 2 and 8 degrees Celsius, that is, between 36 and 46 degrees Fahrenheit. If the vaccine has been frozen, do not use it, and be sure to dispose of it properly.

    Beyond supply, PEDIARIX supports your practice in other practical ways, with cost-savings programs such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

    We hope this video provided you with a better understanding of the dosing, administration, packaging, and storage of PEDIARIX.

    Thank you for partnering with GSK and PEDIARIX. We look forward to supplying the vaccines you need to help your patients and your practice.

    Keep your DTaP immunization routine running smoothly. Order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com, or by contacting your GSK Sales Representative.

    Thank you for watching this video. For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information at PEDIARIX.com.

    TEXT ONSCREEN:

    Continue your DTaP immunization routine without interruption with PEDIARIX.

    Order PEDIARIX today: Call 1-866-475-8222. Visit GSKDirect.com or contact your GSK Sales Representative.

    Schedule a GSK Vaccine Business Review today to find out more about our Premium Partner program. For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report or call 1-800-822-7967.

    DR. LEN FRIEDLAND:

    Important Safety Information for PEDIARIX.

    Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria  toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.

    The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.

    The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions.

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX.

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

    In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite.

    Vaccination with PEDIARIX may not result in protection in all vaccine recipients.

    TEXT ONSCREEN:

    Trademarks are property of their respective owners. ©2021 GSK or licensor. PDRVID200001 February 2021. Produced in USA.