Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004799
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:
1997-01
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 safety and efficacy of acellular 2-component vs acellular multicomponent vs whole-cell pertussis vaccine vs placebo in infants living in Sweden
II Compare the relative protection of each vaccine against atypical or subclinical pertussis infection
III Analyze possible laboratory correlates to vaccine protection
II Compare the relative protection of each vaccine against atypical or subclinical pertussis infection
III Analyze possible laboratory correlates to vaccine protection
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are stratified by participating institution
The first group of infants receives a vaccine composed of inactivated pertussis toxin iPT and filamentous hemagglutin FHA
The second group receives a vaccine containing iPT FHA pertactin agglutinogen 2 and agglutinogen 3
The third group receives a whole-cell pertussis vaccine The fourth group receives a diphtheria-tetanus vaccine as the control All vaccines are given as an intramuscular injection at 2-3 4 and 6 months of age
Close surveillance of infants and families continues for 2-3 years
The first group of infants receives a vaccine composed of inactivated pertussis toxin iPT and filamentous hemagglutin FHA
The second group receives a vaccine containing iPT FHA pertactin agglutinogen 2 and agglutinogen 3
The third group receives a whole-cell pertussis vaccine The fourth group receives a diphtheria-tetanus vaccine as the control All vaccines are given as an intramuscular injection at 2-3 4 and 6 months of age
Close surveillance of infants and families continues for 2-3 years
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 |
|---|---|---|---|
| NBL-SS-19910415 | None | None | None |