The safety and immunogenicity of the first pediatric combination vaccine directed against six diseases is comparable to analogous licensed component vaccines and could help to alleviate “shot burden,” reports a new study in Pediatrics on this novel investigational vaccine.
The multicenter, open-label, comparator-controlled Phase 3 study randomly assigned healthy infants to one of the following groups:
- Group 1 received the fully liquid investigational hexavalanet vaccine directed against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B plus pneumococcal 13-valent conjugate vaccine and pentavalent rotavirus vaccine at 2, 4, and 6 months of age followed by DTaP5, Hib-OMP, and PCV13 at 15 months of age
- Group 2 received DTaP5-IPV/Hib, PCV13, and RV5 at 2, 4, and 6 months of age, with HepB at 2 and 6 months of age, followed by DTaP5, Hib-TT, and PCV13 at 15 months of age
Immune responses to all antigens contained in the investigational vaccines were noninferior to those in group 2, with the exception of antipertussis filamentous hemagglutinin (FHA) geometric mean concentrations (GMCs). The safety profiles were similar among both groups and 26 of the 27 primary immunogenicity end points in this study were met. If approved by the Food and Drug Administration (FDA), this hexavalent vaccine may help to relieve “shot burden” by leading to 1-4 fewer shots for children, the authors conclude.
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