Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines

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

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