Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
- Conditions
- Pertussis
- Registration Number
- NCT00004799
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method