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

National Institute of Allergy and Infectious Diseases (NIAID)10,000 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

10,000

Conditions

Pertussis

Interventions

whole-cell pertussis vaccineBIOLOGICAL

diphtheria-tetanus vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 3 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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