Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00962780 | Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine | PHASE3 | COMPLETED | 303 | — | — | Mar 1, 2010 | Apr 1, 2013 | Nov 17, 2014 | 11 | Romania, South Africa |
| NCT00963235 | Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS | PHASE3 | COMPLETED | 331 | — | — | Nov 1, 2009 | May 1, 2012 | Jun 10, 2013 | 15 | United States |
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart |
| Name | Type | Description |
|---|---|---|
| 13-valent Pneumococcal Conjugate Vaccine (13vPnC) | BIOLOGICAL | 13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3 |
| 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) | BIOLOGICAL | 23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3) |
| Blood draw | PROCEDURE | Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4). |
| 13-valent pneumococcal conjugate vaccine | BIOLOGICAL | Three doses of 13vPnC given 6 months apart. |
Inclusion Criteria: * Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older * Viral load \< 50,000 copies/mL and CD4+ T cell count \>= 200/uL within 6 months before study vaccination * Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any ...