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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-04-30

Brief Summary

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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

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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

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Pertussis

Keywords

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bacterial infection immunologic disorders and infectious disorders pertussis rare disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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whole-cell pertussis vaccine

Intervention Type BIOLOGICAL

diphtheria-tetanus vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

2 Months

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Patrick Olin

Role: STUDY_CHAIR

National Bacteriological Laboratory

Other Identifiers

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NBL-SS-19910415

Identifier Type: -

Identifier Source: secondary_id

199/11953