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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03890367
Brief Summary:
Primary Objective:
To demonstrate:
* the non-inferiority of the seroprotection rate (antibody titers greater than or equal to \[\>=\] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (geometric mean titers \[GMT\]). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT). If this superiority was demonstrated, then
* the superiority of the seroprotection rate.
Or to demonstrate:
* the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT).
Secondary Objective:
To demonstrate:
* the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT).
Or to demonstrate:
* the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then
* the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
* the superiority of the antibody response (GMT) .
Detailed Description:
Study duration per participant was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.
Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events up to 30 days after vaccination, serious adverse events and adverse event of special interest throughout the study.
Study:
NCT03890367
Study Brief:
Protocol Section:
NCT03890367