Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004800
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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
Detailed Description:
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 3331 ratio
One group receives diphtheria-tetanus-pertussis DPT vaccine containing filamentous hemagglutinin FHA Pt-9K129G 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
One group receives diphtheria-tetanus-pertussis DPT vaccine containing filamentous hemagglutinin FHA Pt-9K129G 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISS-RI-11954 | None | None | None |