Key result
A combined pentavalent vaccine with acellular pertussis was at least as immunogenic as the whole-cell pertussis combination, with a significantly better safety profile and higher Hib booster response (P=0.0005).
Why the study?
Does a combined acellular pertussis pentavalent vaccine improve safety and immunogenicity compared to a whole cell pertussis pentavalent vaccine in healthy infants?
Population
201 healthy infants
Comparison
Combined diphtheria-tetanus-acellular… vs Combined diphtheria-tetanus-whole cell…
Design
RCT, Randomized, Open
Follow-up
Up to 13 months of age
Authors
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Supports acellular pertussis pentavalent vaccines for infant schedules; confirms noninferior immunogenicity with superior safety in RCT evidence.
RCT (n=201)
Open-label
randomized
Does a combined acellular pertussis pentavalent vaccine improve safety and immunogenicity compared to a whole cell pertussis pentavalent vaccine in healthy infants?
A combined pentavalent vaccine containing acellular pertussis is at least as immunogenic as one containing whole cell pertussis, with a significantly better safety profile in infants.
Dagan et al. (1997) conducted an RCT in Healthy infants requiring immunization (n=201). Combined pentavalent vaccine with acellular pertussis (Pa) vs. Combined pentavalent vaccine with whole cell pertussis (Pw) was evaluated on Safety and immunogenicity. A combined pentavalent vaccine with acellular pertussis was at least as immunogenic as the whole-cell pertussis combination, with a significantly better safety profile and higher Hib booster response (P=0.0005).
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