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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00521586 | Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine | PHASE3 | COMPLETED | 1,116 | — | — | Sep 1, 2007 | Dec 1, 2013 | Apr 9, 2015 | 41 | United States |
Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5 |
| 2 | OTHER | arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5 |
| Name | Type | Description |
|---|---|---|
| 13 valent pneumococcal conjugate vaccine | BIOLOGICAL | TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5 |
Inclusion Criteria: * Male or female aged 50 to 59 years * Determined by medical history, physical examination and clinical judgement to be eligible for the study * Able to complete electronic diary * Available for the 5 year 9 month duration of the study Exclusion Criteria: * Previous vaccinatio...