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

This study has been completed.
Sponsor:
Collaborator:
Istituto Superiore di Sanita
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004800
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: February 1998

February 24, 2000
June 23, 2005
September 1992
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Complete list of historical versions of study NCT00004800 on ClinicalTrials.gov Archive Site
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
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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.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and randomly assigned to 1 of 3 vaccines and a placebo vaccine in a 3:3:3:1 ratio.

One group receives diphtheria-tetanus-pertussis (DPT) vaccine containing filamentous hemagglutinin (FHA), Pt-9K/129G, and 69 kDA outer membrane protein (OMP).

A second group receives DPT containing FHA and OMP. The third group receives DPT containing whole-cell pertussis. The control group receives diphtheria-tetanus (DT) vaccine. All vaccines are administered as an intramuscular or deep subcutaneous injection at 6-12, 13-20, and 21-28 weeks of age. The first vaccine is given at week 12 if hepatitis B or other immune globulin was given at birth.

All patients receive a DT booster at 11 months, and are followed every 4 weeks for approximately 20 months.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Prevention
Pertussis
  • Biological: diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis
  • Biological: diphtheria-tetanus vaccine
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13250
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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

Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00004800
199/11954, ISS-RI-11954
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National Institute of Allergy and Infectious Diseases (NIAID)
Istituto Superiore di Sanita
Study Chair: Donato Greco Istituto Superiore di Sanita
Office of Rare Diseases (ORD)
February 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP