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Adverse Reactions: Clinical Trials Experience3

  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice
  • A total of 4,013 children were vaccinated with a single dose of KINRIX in 4 clinical trials. Of these, 381 children received a non-US formulation of KINRIX (containing ≤2.5 mg 2-phenoxyethanol per dose as preservative)

Adverse Reactions in a Clinical Study3

  • In a US randomized, controlled clinical trial, children 4 to 6 years of age were vaccinated with KINRIX or control vaccines (INFANRIX and IPOL [inactivated poliovirus vaccine (IPV); Sanofi Pasteur SA])
    • KINRIX: N=3,156
    • INFANRIX and IPOL: N=1,053
    • Vaccination was as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth dose of IPV following 3 doses of IPOL
    • All subjects also received the second dose of US-licensed measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.) concomitantly at separate sites
  • Adverse reactions collection
    • Data on adverse events were collected by parents/guardians using standardized forms for 4 consecutive days following vaccination with KINRIX or control vaccines (ie, day of vaccination and the next 3 days)
 

The reported frequencies of solicited local reactions at the injection site for KINRIX or INFANRIX are shown in the following table.

IPV=inactivated poliovirus vaccine (Sanofi Pasteur SA).
MMR=measles, mumps, and rubella vaccine (Merck & Co., Inc.).
TVC=total vaccinated cohort (all vaccinated subjects for whom safety data were available).

a    Local reactions at the injection site for KINRIX or INFANRIX.
b    Within 4 days of vaccination defined as day of vaccination and the next 3 days.
c    Coadministered with MMR vaccine (Study 048).
d    Statistically higher than comparator group (P <0.05).
e    Grade 2 defined as painful when the limb was moved; Grade 3 defined as preventing normal daily activities.

  • KINRIX was non-inferior to INFANRIX with regard to swelling that involved >50% of the injected upper arm length and that was associated with a >30 mm increase in mid-upper arm circumference within 4 days following vaccination (upper limit of two-sided 95% confidence interval for difference in percentage of KINRIX [0.6%, n=20] minus INFANRIX [1.0%, n=11] ≤2%)

The reported frequencies of solicited local reactions and general adverse events are shown in the following table.

IPV=inactivated poliovirus vaccine (Sanofi Pasteur SA).
MMR=measles, mumps, and rubella vaccine (Merck & Co., Inc.).
TVC=total vaccinated cohort (all vaccinated subjects for whom safety data were available).

a    Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b    Coadministered with MMR vaccine (Study 048).
c    Grade 3 defined as preventing normal daily activities.
d    Statistically higher than comparator group (P <0.05).
e    Grade 3 defined as not eating at all.

References

  1. Prescribing Information for PEDIARIX.
  2. Prescribing Information for INFANRIX.
  3. Prescribing Information for KINRIX.
  4. Centers for Disease Control and Prevention. Recommended Immunization Schedules for Persons Aged 0 Through 18 Years--United States, 2016. http://www.cdc.gov/vaccines/schedules/
    downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed November 12, 2019.
  5. American Medical Association. CPT (Current Procedural Terminology) 2016 Professional Edition. Chicago, IL: American Medical Association; 2015.

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 7th birthday).

Please see full Prescribing Information for PEDIARIX.

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).

Please see full Prescribing Information for INFANRIX.

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 7th 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.

Please see full Prescribing Information for KINRIX.

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 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. 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

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