SAFETY

The established safety profile of PEDIARIX

The safety profile of PEDIARIX was established in 14 clinical trials worldwide.1

23,849 doses of PEDIARIX administered to 8088 infants who received 1 or more doses

Common solicited adverse reactions following any dose (≥25%) included local injection site reactions (pain, redness, and swelling), fever (≥100.4°F), drowsiness, irritability/fussiness, and loss of appetite.1

The safety profile of PEDIARIX was demonstrated in clinical trials and reinforced in a postmarketing safety surveillance study1

Data From a US Safety Study: Percentage of Infants With Solicited Local and General Adverse Reactions Within 4 Days of Vaccinationa at 2, 4, and 6 Months of Age (Modified Intent-to-Treat Cohort)1

Adverse Reactions
  Dose 1 Dose 2 Dose 3
PEDIARIX,
Hib Vaccine,
& PCV7		 INFANRIX,
ENGERIX-B,
IPV,
Hib Vaccine,
& PCV7		 PEDIARIX,
Hib Vaccine,
& PCV7		 INFANRIX,
ENGERIX-B,
IPV,
Hib Vaccine,
& PCV7		 PEDIARIX,
Hib Vaccine,
& PCV7		 INFANRIX,
ENGERIX-B,
IPV,
Hib Vaccine,
& PCV7
Localb
n 671 335 653 323 648 315
Pain, any363236303130
Pain, Grade 2 or 3129119119
Pain, Grade 3233221
Redness, any25c1837334039
Redness, >5 mm6c210c613c7
Redness, >20 mm101c032
Swelling, any17c1027c202925
Swelling, >5 mm6c210c59c4
Swelling, >20 mm213c031
General
n 667 333 644 321 645 311
Feverd , ≥100.4°F28c2039c3034c24
Feverd , >101.3°F75141096
Feverd , >102.2°F2c04332
Feverd , >103.1°F101010
Feverd , M.A.1c00110
n 671 335 653 323 648 315
Drowsiness, any575452484138
Drowsiness, Grade 2 or 3161814121111
Drowsiness, Grade 3341112
Irritability/Fussiness, any616265626157
Irritability/Fussiness, Grade 2 or 3201928c2125c19
Irritability/Fussiness, Grade 3344343
Loss of Appetite, any302831272624
Loss of Appetite, Grade 2 or 3758c365
Loss of Appetite, Grade 3110000
Adverse Reactions
Dose 1Dose 2Dose 3
Dose 1 adverse reactions
 PEDIARIX,
Hib Vaccine,
& PCV7		INFANRIX,
ENGERIX-B,
IPV,
Hib Vaccine,
& PCV7
Localb
n671335
Pain, any3632
Pain, Grade 2 or 3129
Pain, Grade 323
Redness, any25c18
Redness, >5 mm6c2
Redness, >20 mm10
Swelling, any17c10
Swelling, >5 mm6c2
Swelling, >20 mm21
General
n667333
Feverd , ≥100.4°F28c20
Feverd , >101.3°F75
Feverd , >102.2°F2c0
Feverd , >103.1°F10
Feverd , M.A.1c0
n671335
Drowsiness, any5754
Drowsiness, Grade 2 or 31618
Drowsiness, Grade 334
Irritability/
Fussiness,
any		6162
Irritability/
Fussiness,
Grade 2 or 3		2019
Irritability/
Fussiness,
Grade 3		34
Loss of Appetite, any3028
Loss of Appetite, Grade 2 or 375
Loss of Appetite, Grade 311
Dose 2 adverse reactions
 PEDIARIX,
Hib Vaccine,
& PCV7		INFANRIX,
ENGERIX-B,
IPV,
Hib Vaccine,
& PCV7
Localb
n653323
Pain, any3630
Pain, Grade 2 or 3119
Pain, Grade 332
Redness, any3733
Redness, >5 mm10c6
Redness, >20 mm1c0
Swelling, any27c20
Swelling, >5 mm10c5
Swelling, >20 mm3c0
General
n644321
Feverd , ≥100.4°F39c30
Feverd , >101.3°F1410
Feverd , >102.2°F43
Feverd , >103.1°F10
Feverd , M.A.01
n653323
Drowsiness, any5248
Drowsiness, Grade 2 or 31412
Drowsiness, Grade 311
Irritability/
Fussiness,
any		6562
Irritability/
Fussiness,
Grade 2 or 3		28c21
Irritability/
Fussiness,
Grade 3		43
Loss of Appetite, any3127
Loss of Appetite, Grade 2 or 38c3
Loss of Appetite, Grade 300
Dose 3 adverse reactions
 PEDIARIX,
Hib Vaccine,
& PCV7		INFANRIX,
ENGERIX-B,
IPV,
Hib Vaccine,
& PCV7
Localb
n648315
Pain, any3130
Pain, Grade 2 or 3119
Pain, Grade 321
Redness, any4039
Redness, >5 mm13c7
Redness, >20 mm32
Swelling, any2925
Swelling, >5 mm9c4
Swelling, >20 mm31
General
n645311
Feverd , ≥100.4°F34c24
Feverd , >101.3°F96
Feverd , >102.2°F32
Feverd , >103.1°F10
Feverd , M.A.10
n648315
Drowsiness, any4138
Drowsiness, Grade 2 or 31111
Drowsiness, Grade 312
Irritability/
Fussiness,
any		6157
Irritability/
Fussiness,
Grade 2 or 3		25c19
Irritability/
Fussiness,
Grade 3		43
Loss of Appetite, any2624
Loss of Appetite, Grade 2 or 365
Loss of Appetite, Grade 300

  • Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.; no longer licensed in the United States); PCV7 (Wyeth Pharmaceuticals Inc.); IPV (Sanofi Pasteur SA). Modified intent-to-treat cohort=all vaccinated subjects for whom safety data were available.

  • n=number of infants for whom at least 1 symptom sheet was completed; for fever, numbers excludes missing temperature recordings or tympanic measurements.

  • M.A.=medically attended (a visit to or from medical personnel).

  • Grade 2 defined as sufficiently discomforting to interfere with daily activities.

  • Grade 3 defined as preventing normal daily activities.

  • a

    Within 4 days of vaccination defined as day of vaccination and the next 3 days.

  • b

    Local reactions at the injection site for PEDIARIX or INFANRIX.

  • c

    Rate significantly higher in the group that received PEDIARIX compared with separately administered vaccines (P value <0.05 [2-sided Fisher Exact test] or the 95% CI on the difference between groups [Separate minus PEDIARIX] does not include 0).

  • d

    Axillary temperatures increased by 1°C and oral temperatures increased by 0.5°C to derive equivalent rectal temperature.

In a safety surveillance study conducted at a health maintenance organization in the United States, infants who received 1 or more doses of PEDIARIX from mid-2003 through mid-2005 were compared with matched historical controls who received 1 or more doses of separately administered US-licensed DTaP vaccine from 2002 through mid-2003. Meaningful differences with regard to verified seizures and medically attended fever were not observed.1

  • CI=confidence interval; DTaP=diphtheria, tetanus, and acellular pertussis.

INDICATIONS & IMPORTANT SAFETY INFO FOR PEDIARIX, INFANRIX, AND KINRIX

INDICATIONS FOR PEDIARIX, INFANRIX, AND KINRIX

IMPORTANT SAFETY INFORMATION FOR PEDIARIX, INFANRIX, AND KINRIX

INDICATIONS FOR PEDIARIX, INFANRIX, AND KINRIX

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 (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh 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 seventh 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 (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.

Indication for HIBERIX 

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 fifth birthday).

Indication for ENGERIX-B  

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

IMPORTANT SAFETY INFORMATION FOR PEDIARIX, INFANRIX, AND KINRIX

  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX 
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine or to any component of INFANRIX is a contraindication for INFANRIX
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, or poliovirus-containing vaccine or to any component of KINRIX, including neomycin and polymyxin B, is a contraindication for KINRIX
  • Additional contraindications for PEDIARIX, INFANRIX, and KINRIX are: 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 receipt of a prior vaccine containing tetanus toxoid, or if adverse events (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 cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • 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. Vaccination with PEDIARIX or INFANRIX should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination 
  • In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), 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
IMPORTANT SAFETY INFORMATION FOR HIBERIX
  • 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. 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
IMPORTANT SAFETY INFORMATION FOR ENGERIX-B
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast, is a contraindication to administration of ENGERIX-B
  • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • 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
  • Temporarily defer ENGERIX-B vaccination of infants with a birth weight less than 2,000 grams born to hepatitis B surface antigen (HBsAg)-negative mothers
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely
  • lmmunocompromised persons, including individual receiving immunosuppressive therapy, may have a diminished immune response to ENGERIX-B
  • In clinical trials with ENGERIX-B, the most frequently reported adverse reactions were injection-site soreness and fatigue
  • Vaccination with ENGERIX-B may not result in protection in all vaccine recipients

 

Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Prescribing Information for INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

Prescribing Information for KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Prescribing Information for HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]

Prescribing Information for ENGERIX-B [Hepatitis B Vaccine (Recombinant)]

References

  1. Prescribing Information for PEDIARIX.