Brief Title
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
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.
Study Phase
Phase 3
Study Type
Interventional
Condition
Pertussis
Intervention
whole-cell pertussis vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
10000
Start Date
April 1991
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Population Characteristics-- - Infants aged 2 months at planned date of first vaccination - No prior pertussis confirmed by culture - The following do not exclude: Down syndrome Prematurity Healthy babies vaccinated according to chronological age Recent pertussis exposure Seizures in parent or sibling Sudden infant death in sibling Close relative with history of anaphylaxis or allergy Close relative with history of strong reaction to vaccination --Patient Characteristics-- - Age: Under 3 months - Renal: No renal failure - Other: No prior gammaglobulin No requirement for immunosuppressives, e.g., HIV infection No manifest immunosuppression No serious chronic illness associated with failure to thrive No cardiac disease No progressive neurologic disease No uncontrolled epilepsy or infantile spasms No parental language or communication barrier
Gender
All
Ages
2 Months - 3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Patrick Olin, ,
Administrative Informations
NCT ID
NCT00004799
Organization ID
199/11953
Secondary IDs
NBL-SS-19910415
Study Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
National Bacteriological Laboratory
Study Sponsor
Patrick Olin, Study Chair, National Bacteriological Laboratory
Verification Date
January 1997