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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00518180 | A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents | PHASE3 | COMPLETED | 1,620 | — | — | Jul 1, 2007 | Oct 1, 2008 | May 18, 2016 | 1 | Costa Rica |
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer \<1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
| Arm | Type | Description |
|---|---|---|
| MenACWY + Tdap + HPV | EXPERIMENTAL | Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6 |
| MenACWY →Tdap → HPV | EXPERIMENTAL | Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8 |
| Tdap →MenACWY → HPV | EXPERIMENTAL | Subjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8 |
| Name | Type | Description |
|---|---|---|
| Novartis Meningococcal ACWY Conjugate Vaccine | BIOLOGICAL | One dose of vaccine administered intramuscularly |
| Tdap Vaccine | BIOLOGICAL | One dose of vaccine administered intramuscularly |
Inclusion Criteria: * Healthy adolescents 11-18 years of age * virgins (both male and female) with no intention of becoming sexually active during the study period * who have been properly vaccinated against diphtheria, tetanus, pertussis Exclusion Criteria: * who had a previous confirmed or susp...