Meningococcal Immunisation (Healthy Volunteers) Clinical Trial
Official title:
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age
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) .
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. ;