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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
707
Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Investigational Site Number 2080001
Aarhus, Denmark
Investigational Site Number 2080002
Hvidovre, Denmark
Investigational Site Number 2080003
Odense, Denmark
Investigational Site Number 2460006
Espoo, Finland
Investigational Site Number 2460005
Helsinki, Finland
Investigational Site Number 2460004
Jarvenpaa, Finland
Investigational Site Number 2460008
Kokkola, Finland
Investigational Site Number 2460007
Oulu, Finland
Investigational Site Number 2460003
Pori, Finland
Investigational Site Number 2460010
Seinäjoki, Finland
...and 19 more locations
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Time frame: Day 30 (post-vaccination)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Time frame: Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
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