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Immunogenicity of Infanrix™ hexa administered at 3, 5 and 11 months of age

Olivier Van Der Meeren1, Sherine Kuriyakose, Devayani Kolhe

  • 1GlaxoSmithKline Biologicals, 20 Fleming Avenue, Wavre, Belgium. Olivier.x.Van-Der-Meeren@gskbio.com

Vaccine
|February 22, 2012
PubMed

Insights

Infanrix™ hexa (DTPa-HBV-IPV/Hib) vaccination in infants demonstrated high immunogenicity against diphtheria, tetanus, hepatitis B, polio, Hib, and pertussis. The vaccine proved safe and effective with a 3, 5, and 11-month schedule.

Area of Science:

  • Pediatric Vaccinology
  • Immunology
  • Public Health

Background:

  • The DTaP-HBV-IPV/Hib vaccine (Infanrix™ hexa) is crucial for infant immunization.
  • Assessing vaccine immunogenicity and safety in diverse populations is essential.

Purpose of the Study:

  • To evaluate the immunogenicity of Infanrix™ hexa in 702 healthy infants.
  • To assess the immune response following a 3, 5, and 11-12 month vaccination schedule.

Main Methods:

  • Pooled analysis of data from four European vaccination studies.
  • Serological assessment of antibody levels against diphtheria, tetanus, hepatitis B, poliovirus, Hib, and pertussis antigens.
  • Monitoring of adverse events post-vaccination.

Main Results:

  • High seroprotective antibody levels (96.3-100%) against diphtheria, tetanus, hepatitis B, and poliovirus after two doses.
  • Over 91.7% seropositivity for Hib and ≥99.0% for pertussis antigens after two doses.
  • 98.9-100% seroprotection/seropositivity for all antigens after the third dose, with significant increases in geometric mean titers.

Conclusions:

  • Infanrix™ hexa elicits a robust immune response in infants following a 3, 5, and 11-month schedule.
  • The vaccine demonstrates adequate immunogenicity and a favorable safety profile.
  • The 2-dose primary plus booster schedule is effective for comprehensive infant immunization.

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