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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

whole-cell pertussis vaccine

diphtheria-tetanus vaccine

About this trial

This is an interventional prevention trial for Pertussis focused on measuring bacterial infection, immunologic disorders and infectious disorders, pertussis, rare disease

Eligibility Criteria

2 Months - 3 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004799

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Bacteriological Laboratory

1. Study Identification

Unique Protocol Identification Number

NCT00004799

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 1997

Overall Recruitment Status

Completed

Study Start Date

April 1991 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Bacteriological Laboratory

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pertussis

Keywords

bacterial infection, immunologic disorders and infectious disorders, pertussis, rare disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Masking

Double

Allocation

Randomized

Enrollment

10000 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

whole-cell pertussis vaccine

Intervention Type

Biological

Intervention Name(s)

diphtheria-tetanus vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Olin

Organizational Affiliation

National Bacteriological Laboratory

Official's Role

Study Chair

Pertussis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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