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

NCT00004799 | Completed Phase 3

• 2 other identifiers: 199/11953NBL-SS-19910415
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pertussis

Keywords

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

Interventions

whole-cell pertussis vaccine BIOLOGICAL

diphtheria-tetanus vaccine BIOLOGICAL

Eligibility Criteria

• Age: 2 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Bacteriological Laboratory: collaborator

MeSH Terms

Conditions

Whooping Cough; Bacterial Infections; Immune System Diseases; Communicable Diseases; Rare Diseases

Interventions

Diphtheria-Tetanus Vaccine

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined

Study Officials

• Patrick Olin

  National Bacteriological Laboratory

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: April 1, 1991
• Last Updated: June 24, 2005

Record last verified: 1997-01