A Phase 3 interventional study of diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis and diphtheria-tetanus vaccine in Pertussis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Prevention
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.
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 13,250 is above the median of 375 across 180 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
No study locations are listed for this record.
This study is completed, as verified in Feb 1998. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)