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

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ClinicalTrials.gov Identifier: NCT00004799
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
National Bacteriological Laboratory
Information provided by:
Office of Rare Diseases (ORD)

Brief 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.


Condition or disease Intervention/treatment Phase
Pertussis Biological: whole-cell pertussis vaccine Biological: diphtheria-tetanus vaccine Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 10000 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : April 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 3 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004799


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Bacteriological Laboratory
Investigators
Study Chair: Patrick Olin National Bacteriological Laboratory

ClinicalTrials.gov Identifier: NCT00004799     History of Changes
Other Study ID Numbers: 199/11953
NBL-SS-19910415
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1997

Keywords provided by Office of Rare Diseases (ORD):
bacterial infection
immunologic disorders and infectious disorders
pertussis
rare disease

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs