CompletedPhase 3

Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers

Denmark, Finland707 participantsStarted 2019-09-12

Plain-language 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) .

Who can participate

Age range12 Months – 23 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria : * Aged 12 to 23 months on the day of the first study visit ("12 to 23 months" means from the 12th month after birth to the day before the 24th month after birth). * Informed consent form (ICF) had been signed and dated by the parent(s)/legally acceptable representative(s) and by an independent witness if required by local regulations. * Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures. Exclusion criteria: * Participation in the 4 weeks (28 days) preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B vaccine). * Known or suspected congenital or acquired immunodeficiency; or receipt of immunos…

What they're measuring

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)

Timeframe: 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)

Timeframe: Day 30 (post-vaccination)

GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Trial details

NCT IDNCT03890367

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-14

Results submitted2021-09-09

View on ClinicalTrials.gov More Meningococcal Immunisation (Healthy Volunteers) trials

Plain-language summary

Who can participate

Age range12 Months – 23 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 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)

Timeframe: Day 30 (post-vaccination)

GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)

Timeframe: 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)

Timeframe: 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)