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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Bacteriological Laboratory |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004799 |
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 | Intervention | Phase |
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Pertussis |
Biological: whole-cell pertussis vaccine Biological: diphtheria-tetanus vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
Estimated Enrollment: | 10000 |
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.
Ages Eligible for Study: | 2 Months to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
PROTOCOL ENTRY CRITERIA:
--Population Characteristics--
--Patient Characteristics--
Study ID Numbers: | 199/11953, NBL-SS-19910415 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004799 |
Health Authority: | United States: Federal Government |
bacterial infection immunologic disorders and infectious disorders pertussis rare disease |
Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Rare Diseases |
Cough Whooping Cough Whooping cough Gram-Negative Bacterial Infections |
Bordetella Infections Infection |