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

NCT00004800 | Completed Phase 3

• 2 other identifiers: 199/11954ISS-RI-11954
• Study Type: interventional
• Target: 13,250
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell pertussis vaccine vs. placebo in infants living in Italy. II. Compare the relative protection of each of the acellular vaccines vs. the whole-cell vaccine vs. laboratory-confirmed pertussis. III. Assess the relative efficacy of the acellular vaccines with respect to one another. IV. Assess the immunogenicity of acellular vs. whole-cell vaccines in the study population. V. Compare the frequency of adverse events with each vaccine. VI. Compare the frequency of adverse events attributable to the pertussis component in each of the 3 vaccines. VII. Assess alternative laboratory diagnostic techniques for pertussis in estimating vaccine efficacy, i.e., mucosal immune response, DNA probes, or antibody response to other components of the organism. VIII. Assess the relative efficacy estimates of each vaccine, using clinical criteria to compare the relative incidence rates in each vaccine group.

Conditions

Pertussis

Keywords

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

Interventions

diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis BIOLOGICAL

diphtheria-tetanus vaccine BIOLOGICAL

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

PROTOCOL ENTRY CRITERIA: --Population Characteristics-- Newborns enrolled at first vaccine clinic visit Weight at first vaccination at least third percentile, i.e.: Girls: 3.2 to 3.8 kg Boys: 3.4 to 4.0 kg No previous illness compatible with pertussis --Prior/Concurrent Therapy-- No prior pertussis vaccination --Patient Characteristics-- Age: Over 6 weeks to under 12 weeks Renal: No renal failure Other: No prior prolonged immunosuppressive therapy No prior systemic corticosteroids, unless duration less than 14 days and at least 48 hours since last dose No major congenital abnormality No failure to thrive No known or possible immune system deficit, e.g.: HIV-infected mother Autoimmune anemia Lymphoma Other erythropoietic disease No perinatal central nervous system disease or damage No history of convulsions Mother Italian-speaking and accessible by telephone Planned residence in clinic district for at least 1 year

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
• Istituto Superiore di Sanità: collaborator

Related Publications (1)

• Greco D, Salmaso S, Mastrantonio P, Giuliano M, Tozzi AE, Anemona A, Ciofi degli Atti ML, Giammanco A, Panei P, Blackwelder WC, Klein DL, Wassilak SG. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. Progetto Pertosse Working Group. N Engl J Med. 1996 Feb 8;334(6):341-8. doi: 10.1056/NEJM199602083340601.

  PMID: 8538704 BACKGROUND

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

• Donato Greco

  Istituto Superiore di Sanità

  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: September 1, 1992
• Last Updated: June 24, 2005

Record last verified: 1998-02