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
Summary
Primary Objective: To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement \[hSBA\] titer greater than or equal to \[\>=\] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2). Secondary Objective: To describe: * the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine \[adsorbed, reduced antigen(s) content\] (Tdap-IPV) vaccines (Group 3). * the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status. * the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination. * the safety profile in each group after each and any vaccination.
Timeline
- Start
- 2021-03-16
- Primary completion
- 2022-05-11
- Completion
- 2022-05-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human Papillomavirus 9-valent Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | MenACYW conjugate vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Meningococcal group A, C, W-135, and Y conjugate vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | tetanus toxoid | Vaccine | 0.5 ml | Intramuscular |