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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) National Bacteriological Laboratory
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004799

Purpose

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.

Condition	Intervention	Phase
Pertussis	Biological: whole-cell pertussis vaccine Biological: diphtheria-tetanus vaccine	Phase III

MedlinePlus related topics: Whooping Cough

Drug Information available for: Tetanus Vaccine Diphtheria-Tetanus Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	10000
Study Start Date:	April 1991

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.

Eligibility

Ages Eligible for Study:	2 Months to 3 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004799

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

National Bacteriological Laboratory

Investigators

Study Chair:

Patrick Olin

National Bacteriological Laboratory

More Information

No publications provided

Study ID Numbers:	199/11953, NBL-SS-19910415
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004799 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

bacterial infection
immunologic disorders and infectious disorders
pertussis
rare disease

Study placed in the following topic categories:

Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Rare Diseases

Cough
Whooping Cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Bordetella Infections
Respiratory Tract Diseases
Respiratory Tract Infections

Whooping Cough
Infection
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on May 07, 2009