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13-valent Pneumoccocal Conjugate Vaccine · 1 trial · 1 indication
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 ...
13-valent Pneumococcal Conjugate Vaccine is an investigational vaccine being studied for use in children with sickle cell disease to help prevent pneumococcal infection. It is currently in Phase 3 clinical development and has not been approved by the FDA.
13-valent Pneumococcal Conjugate Vaccine is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in pediatric patients.
13-valent Pneumococcal Conjugate Vaccine is currently in Phase 3 clinical development. It is an investigational product and has not received FDA approval. The Phase 3 trial has been completed, with results expected to inform potential regulatory submissions.
13-valent Pneumococcal Conjugate Vaccine has one completed Phase 3 trial, identified as NCT00918580. This study evaluated the vaccine in 158 children with sickle cell disease across multiple countries, including the United States, Egypt, France, Italy, Lebanon, Saudi Arabia, and the United Kingdom.
13-valent Pneumococcal Conjugate Vaccine is the generic name for the vaccine commonly known as Prevnar 13. The clinical trial data provided refers to this vaccine, which is being studied for use in children with sickle cell disease to prevent pneumococcal infection.