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Novartis Meningococcal ACWY Conjugate Vaccine · 1 trial · 4 indications
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...
Novartis Meningococcal ACWY Conjugate Vaccine is an investigational vaccine being studied for the prevention of meningococcal meningitis, a serious bacterial infection. It is designed to protect against meningococcal disease caused by serogroups A, C, W, and Y. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Novartis Meningococcal ACWY Conjugate Vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immune response in adolescent populations.
Novartis Meningococcal ACWY Conjugate Vaccine is in Phase 3 clinical development. This late-stage trial has been completed, with a total enrollment of 1,620 participants. The vaccine remains investigational and has not received FDA approval, as it is still undergoing clinical evaluation to establish its safety and efficacy profile.
Novartis Meningococcal ACWY Conjugate Vaccine has been studied in one completed Phase 3 clinical trial registered as NCT00518180. This trial evaluated the safety and immune response of the vaccine in adolescents aged 11 years and older, with 1,620 participants enrolled in Costa Rica. The study was controlled but not double-blinded.
Novartis Meningococcal ACWY Conjugate Vaccine is a conjugate vaccine designed to protect against four serogroups of Neisseria meningitidis: A, C, W, and Y. While it is a meningococcal conjugate vaccine, it is specifically formulated to target these four serogroups, distinguishing it from vaccines that cover fewer serogroups.