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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 3

Conditions: Pertussis

Treatments: Biological: whole-cell pertussis vaccine; Biological: diphtheria-tetanus vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004799

NBL-SS-19910415

199/11953

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 2 to 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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