Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT04490018
Brief 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.
Detailed Description:
The duration of study participation for each participant was approximately 30 to 60 days, including 2 or 3 visits (1 or 2 vaccination visit) and 1 or 2 telephone calls, depending on study Group.
\* This was the first dose of 9vHPV, of the 2-dose or 3-dose series according to the local recommendations and age of the participant. These additional vaccinations for the completion of 9vHPV schedule took place outside of the objectives and scope of this study and thus were not described in this protocol.
Study:
NCT04490018
Study Brief:
Protocol Section:
NCT04490018