Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
|First Received Date ICMJE||February 24, 2000|
|Last Updated Date||June 23, 2005|
|Start Date ICMJE||September 1992|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines|
|Official Title ICMJE||Not Provided|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Prevention
|Study Arm (s)||Not Provided|
|Publications *||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.
|Recruitment Status ICMJE||Completed|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||6 Weeks to 12 Weeks (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00004800|
|Other Study ID Numbers ICMJE||199/11954, ISS-RI-11954|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Istituto Superiore di Sanità|
|Information Provided By||Office of Rare Diseases (ORD)|
|Verification Date||February 1998|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP