Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000829
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects To assess whether this vaccine is more immunogenic than placebo following the third vaccination
Children with HIV infection are at increased risk for invasive pneumococcal infection particularly bacteremia A large proportion of pneumococcal disease is caused by a limited number of serotypes The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4 6B 9V 14 18C 19F and 23F bound to a diphtheria toxin mutant carrier protein
Children with HIV infection are at increased risk for invasive pneumococcal infection particularly bacteremia A large proportion of pneumococcal disease is caused by a limited number of serotypes The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4 6B 9V 14 18C 19F and 23F bound to a diphtheria toxin mutant carrier protein
Detailed Description:
Children with HIV infection are at increased risk for invasive pneumococcal infection particularly bacteremia A large proportion of pneumococcal disease is caused by a limited number of serotypes The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4 6B 9V 14 18C 19F and 23F bound to a diphtheria toxin mutant carrier protein
Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0 2 and 4 and then at 15 months of age Additionally patients receive PNU-IMUNE 23 pneumococcal polyvalent vaccine at 24 months of age
Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0 2 and 4 and then at 15 months of age Additionally patients receive PNU-IMUNE 23 pneumococcal polyvalent vaccine at 24 months of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11268 | REGISTRY | DAIDS ES Registry Number | None |