Pertussis Clinical Trial
OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular
multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden.
II. Compare the relative protection of each vaccine against atypical or subclinical
pertussis infection.
III. Analyze possible laboratory correlates to vaccine protection.
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
participating institution.
The first group of infants receives a vaccine composed of inactivated pertussis toxin (iPT)
and filamentous hemagglutin (FHA).
The second group receives a vaccine containing iPT, FHA, pertactin, agglutinogen 2, and
agglutinogen 3.
The third group receives a whole-cell pertussis vaccine. The fourth group receives a
diphtheria-tetanus vaccine as the control. All vaccines are given as an intramuscular
injection, at 2-3, 4, and 6 months of age.
Close surveillance of infants and families continues for 2-3 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention
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