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Immunological Evaluation of KINRIX3

  • US multicenter study (Study 048)
    • 4,209 children 4 through 6 years of age who previously had received 4 doses of INFANRIX, 3 doses of inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA), and 1 dose of measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.)
    • Randomized 3:1 to KINRIX or INFANRIX and IPV administered concomitantly at separate sites
    • All children were administered MMR
  • Immunological evaluation
    • Antibodies to the diphtheria, tetanus, pertussis (PT, FHA, and pertactin), and poliovirus antigens measured in sera obtained immediately prior to vaccination and 1 month (range 31 to 48 days) after vaccination
    • The co-primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs) 1 month after vaccination

The efficacy of the pertussis component of KINRIX was determined in clinical trials of INFANRIX administered as a 3-dose series in infants.

  • KINRIX was shown to be non-inferior to INFANRIX and IPV administered separately, in terms of booster responses to DTaP antigens
  • KINRIX was also shown to be non-inferior to INFANRIX and IPV administered separately, in terms of post-vaccination GMTs for anti-poliovirus antibodies

Anti-diphtheria toxoid and anti-tetanus toxoid booster responses are shown in the following table.

IPV=inactivated poliovirus vaccine (Sanofi Pasteur SA).
MMR=measles, mumps, and rubella vaccine (Merck & Co., Inc.).
ATP=according to protocol.
CI=confidence interval.

a    One-month blood sampling; range 31 to 48 days.
b    Coadministered with MMR vaccine (Study 048).
c    Seroprotection defined as anti-diphtheria toxoid and anti-tetanus toxoid antibody concentrations ≥0.1 IU/mL by ELISA.
d    Booster response: In subjects with pre-vaccination <0.1 IU/mL, post-vaccination concentration ≥0.4 IU/mL. In subjects with pre-vaccination concentration ≥0.1 IU/mL, an increase of at least 4 times the pre-vaccination concentration.
e    KINRIX was non-inferior to INFANRIX + IPV based on booster response rates (upper limit of two-sided 95% CI on the difference of INFANRIX + IPV minus KINRIX ≤10%).

Anti-PT, anti-FHA, and anti-pertactin booster responses are shown in the following table.

IPV=inactivated poliovirus vaccine (Sanofi Pasteur SA).
MMR=measles, mumps, and rubella vaccine (Merck & Co., Inc.).
ATP=according to protocol.
CI=confidence interval.

a    One-month blood sampling; range 31 to 48 days.
b    Coadministered with MMR vaccine (Study 048).
c    Booster response: In subjects with pre-vaccination <5 EL.U./mL, post-vaccination concentration ≥20 EL.U./mL. In subjects with pre-vaccination ≥5 EL.U./mL and <20 EL.U./mL, an increase of at least 4 times the pre-vaccination concentration. In subjects with pre-vaccination ≥20 EL.U./mL, an increase of at least 2 times the pre-vaccination concentration.

d    KINRIX was non-inferior to INFANRIX + IPV based on booster response rates (upper limit of two-sided 95% CI on the difference of INFANRIX + IPV minus KINRIX ≤10%).

Post-vaccination GMTs for anti-poliovirus antibodies are shown in the following table.

IPV=inactivated poliovirus vaccine (Sanofi Pasteur SA).
MMR=measles, mumps, and rubella vaccine (Merck & Co., Inc.).
ATP=according to protocol.
CI=confidence interval.
GMT=geometric mean antibody titers.

a    One-month blood sampling; range 31 to 48 days.
b    Coadministered with MMR vaccine (Study 048).
c    Seroprotection defined as anti-poliovirus Type 1, Type 2, and Type 3 antibody titer ≥1:8 by micro-neutralization assay for poliovirus.

d    KINRIX was non-inferior to INFANRIX + IPV based on post-vaccination anti-poliovirus antibody GMTs adjusted for baseline titer (upper limit of two-sided 95% CI for the GMT ratio [INFANRIX + IPV:KINRIX] ≤1.5).

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

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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