Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
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.
Biological: whole-cell pertussis vaccine
Biological: diphtheria-tetanus vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Prevention
|Study Start Date:||April 1991|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004799
|Study Chair:||Patrick Olin||National Bacteriological Laboratory|