SCHEDULE FLEXIBILITY

Maintain the continuity of your schedule with the GSK portfolio of pediatric vaccines*

PEDIARIX has been the foundation of the GSK DTaP-containing portfolio of pediatric vaccines since 2002.1

HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
HepB, DTaP, IPV, and Hib From Birth Through 6 Years of Age chart
  • PEDIARIX as a primary series: 3 doses of 0.5 mL each, by intramuscular injection, at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks)1
  • According to CDC, administration of a total of 4 doses of hepatitis B vaccine is permitted when a combination vaccine containing hepatitis B is administered after the birth dose6
  • A 3-dose series of PEDIARIX may be administered to infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth.1 However, data are limited regarding the safety of PEDIARIX in such infants1

CDC=Centers for Disease Control and Prevention; DTaP=diphtheria, tetanus, and acellular pertussis; HBsAg=hepatitis B surface antigen; HepB=hepatitis B; Hib=Haemophilus influenzae type b; IPV=inactivated poliovirus vaccine.

*Data are not available on the safety and effectiveness of using PEDIARIX following 1 or more doses of a DTaP vaccine from a different manufacturer.1

GSK’s DTaP-containing vaccines are to be administered according to their approved indications.

 

PEDIARIX gives you flexibility to catch up those appropriate patients who fell behind schedule: Pentacel and Vaxelis are indicated until the 5th birthday1,7,8

PEDIARIX Vaccination Schedule chart PEDIARIX Vaccination Schedule chart
  • The recommended dosing interval for PEDIARIX is 6 to 8 weeks, preferably 8 weeks1
  • Three doses of PEDIARIX constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis and the complete vaccination course for hepatitis B1
  • Data are not available on the safety and effectiveness of using PEDIARIX following 1 or more doses of a DTaP vaccine from a different manufacturer1

Watch a video about the schedule flexibility of PEDIARIX

  • 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.

 

CDC prefers that vaccine doses in a DTaP series come from the same manufacturer when possible.9

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 the 7th birthday.1-3

Watch a video about the GSK portfolio of pediatric vaccines

  • 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.1 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.