- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004799
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Patrick Olin, National Bacteriological Laboratory
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/11953
- NBL-SS-19910415
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on diphtheria-tetanus vaccine
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National Institute of Allergy and Infectious Diseases...Istituto Superiore di SanitàCompleted
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Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Whooping Cough | Tetanus | DiphtheriaUnited States
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Biomat USA, Inc.Axio Research. LLC; Hammond Clinical Trial Consulting, LLCCompleted
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Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Whooping Cough | Tetanus | DiphtheriaUnited States, Canada
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Green Cross CorporationCompletedBacterial InfectionsKorea, Republic of
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GlaxoSmithKlineCompletedTetanus | Diphtheria | Acellular PertussisUnited States
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GlaxoSmithKlineTerminatedHepatitis B | Tetanus | Diphtheria | Haemophilus Influenzae Type b | Whole Cell PertussisDominican Republic