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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04490018 | Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents | PHASE3 | COMPLETED | 463 | — | — | Mar 16, 2021 | May 11, 2022 | Sep 12, 2025 | 23 | Hungary, Italy +2 |
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.
| Arm | Type | Description |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | EXPERIMENTAL | Participants received 0.5-milliliter (mL) intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | ACTIVE_COMPARATOR | Participants received 0.5-mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | EXPERIMENTAL | Participants received 0.5-mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
| Name | Type | Description |
|---|---|---|
| Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) | BIOLOGICAL | Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular |
| Meningococcal group A, C, W-135, and Y conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular |
| Human Papillomavirus 9-valent Vaccine (9vHPV) | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV) | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
Inclusion Criteria: * Aged 10 to 17 years on the day of inclusion ('10 to 17 years' means from the day of the 10th birthday to the day before the 18th birthday). * Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infanc...