NCT00004799

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,000 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 2 Months – 3 Months
• Healthy volunteers: Accepted

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.

Conditions

• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	whole-cell pertussis vaccine
BIOLOGICAL	diphtheria-tetanus vaccine

Timeline

• Start date: 1991-04-01
• First posted: 2000-02-25
• Last updated: 2005-06-24