Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
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|ClinicalTrials.gov Identifier: NCT00004799|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Pertussis||Biological: whole-cell pertussis vaccine Biological: diphtheria-tetanus vaccine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10000 participants|
|Study Start Date :||April 1991|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004799
|Study Chair:||Patrick Olin||National Bacteriological Laboratory|