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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00918580 | Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease | PHASE3 | COMPLETED | 158 | — | — | Nov 1, 2009 | Mar 1, 2013 | Apr 21, 2014 | 19 | United States, Egypt +5 |
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 1 to 1 month after 13vPnC Dose 2 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 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 13-valent Pneumoccocal Conjugate Vaccine | BIOLOGICAL | 2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months. |
Inclusion Criteria: * Male or female subject between the ages of \>=6 to \<18 years. * Diagnosis of SCD * 23vPS vaccination at least 6 months prior to enrollment. Exclusion Criteria: * Previous vaccination with pneumococcal conjugate vaccine. * Previous reaction to any vaccine or vaccine-related ...