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Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as

I Tichmann1, H Preidel, D Grunert

  • 1Arztpraxis München, Germany.

Vaccine
|April 20, 2005
PubMed

Insights

Infanrix hexa demonstrated superior immunogenicity for the hepatitis B vaccine component compared to Hexavac in infants. Antibody responses to diphtheria and polio were also higher with Infanrix hexa, with similar safety profiles.

Area of Science:

  • Pediatric Vaccinology
  • Immunology
  • Public Health

Background:

  • Infant vaccination schedules are critical for establishing early immunity against serious diseases.
  • Comparative studies are essential to evaluate the efficacy and safety of different vaccine formulations.

Purpose of the Study:

  • To compare the immunogenicity and safety of Infanrix hexa versus Hexavac vaccines in infants.
  • To assess antibody responses to hepatitis B, diphtheria, polio, tetanus, Hib, and pertussis components.

Main Methods:

  • A randomized trial involving 459 infants receiving either Infanrix hexa or Hexavac at 2, 4, and 6 months.
  • Immunogenicity assessed via seroprotection rates and Geometric Mean Concentrations (GMCs) for hepatitis B.
  • Antibody levels measured for diphtheria, polio, tetanus, Hib, and pertussis components.

Main Results:

  • Infanrix hexa showed statistically significantly higher hepatitis B seroprotection (98.6% vs 94.7%) and GMCs (905.6 vs 226.4).
  • Significantly higher antibody levels against diphtheria and polio were observed with Infanrix hexa (p < 0.0001).
  • Comparable immune responses were noted for tetanus, Hib, and pertussis components; low adverse event rates in both groups.

Conclusions:

  • Infanrix hexa offers superior immunogenicity for its hepatitis B component compared to Hexavac in infants.
  • Infanrix hexa also induces higher antibody levels for diphtheria and polio antigens.
  • Both vaccines exhibited favorable safety profiles, with low incidences of adverse events.

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