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

Pertussis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004799
• Other study ID #: 199/11953
• Secondary ID: NBL-SS-19910415
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: April 1991

Study information

• Verified date: January 1997
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 3 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

Biological:
• whole-cell pertussis vaccine

• diphtheria-tetanus vaccine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	National Bacteriological Laboratory