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Six-component vaccines: new preparations. Simpler hepatitis B vaccination of infants

    Prescrire International
    |May 20, 2004
    PubMed

    Insights

    Two six-component infant vaccines, Hexavac and InfanrixHexa, were evaluated. While generally comparable to separate vaccines, both showed weaker immune responses to specific components, with unknown long-term clinical impact.

    Area of Science:

    • Pediatric Vaccinology
    • Immunology
    • Public Health

    Background:

    • Two hexavalent vaccines (diphtheria, tetanus, poliomyelitis, Haemophilus influenzae type b, acellular pertussis, and hepatitis B) are available in France for infant immunization.
    • These vaccines combine a pentavalent vaccine with a hepatitis B vaccine in a single intramuscular injection.

    Purpose of the Study:

    • To compare the immunogenicity and safety of Hexavac and InfanrixHexa against separate vaccine administration in infants.
    • To assess the clinical evaluation data for these combined vaccines.

    Main Methods:

    • Review of clinical evaluation dossiers and published trials for InfanrixHexa and Hexavac.
    • Comparison of serological responses and adverse events following primary and booster vaccinations.

    Main Results:

    • InfanrixHexa showed comparable immunogenicity to separate vaccines for five components, but a weaker response to Haemophilus influenzae type b.
    • Hexavac demonstrated significantly weaker serological responses to hepatitis B virus and Haemophilus influenzae type b compared to separate vaccines.
    • Both vaccines were generally well-tolerated, with no significant differences in adverse events for InfanrixHexa post-primary vaccination and Hexavac post-primary vaccination compared to separate administration.

    Conclusions:

    • The clinical implications of the reduced serological responses to specific components with InfanrixHexa and Hexavac remain unknown.
    • The choice of vaccination schedule may depend on the need for early hepatitis B vaccination at birth.
    • Further research is needed to fully understand the long-term clinical protection offered by these combined vaccines.

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