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

Phase 3

Completed

• Conditions: Meningococcal Immunisation (Healthy Volunteers)
• Interventions: Biological: Meningococcal group C polysaccharide Conjugate vaccine adsorbed; Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine; Biological: Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine

• Registration Number: NCT03890367
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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 Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-09-12
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Results First Submitted: 2021-09-09
• Results First Submitted QC: 2021-09-09
• Results First Posted: 2021-10-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 707

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: NeisVac-C® Vaccine	Meningococcal group C polysaccharide Conjugate vaccine adsorbed	Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
Group 1: MenACYW Conjugate Vaccine	Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine	Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
Group 2: Nimenrix® Vaccine	Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine	Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
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)	Day 30 (post-vaccination)	Antibody titers against Meningococcal Serogroup C were measured by hSBA.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
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)	Day 30 (post-vaccination)	Antibody titers against Meningococcal Serogroup C were measured by hSBA.
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)	Day 30 (post-vaccination)	Antibody titers against Meningococcal Serogroup C were measured by rSBA.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.

Secondary Outcome Measures

Name	Time	Method
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)	Day 30 (post-vaccination)	Antibody titers against Meningococcal Serogroup C were measured by rSBA.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
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)	Day 30 (post-vaccination)	Antibody titers against Meningococcal Serogroup C were measured by hSBA.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)	Day 30 (post-vaccination)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.

Trial Locations

Locations (29)

Investigational Site Number 2460006; 🇫🇮 Espoo, Finland

Investigational Site Number 2760019; 🇩🇪 Bretten, Germany

Investigational Site Number 2760017; 🇩🇪 Hamburg, Germany

Investigational Site Number 2760013; 🇩🇪 Itzehoe, Germany

Investigational Site Number 2460008; 🇫🇮 Kokkola, Finland

Investigational Site Number 2460005; 🇫🇮 Helsinki, Finland

Investigational Site Number 2460010; 🇫🇮 Seinäjoki, Finland

Investigational Site Number 2460004; 🇫🇮 Järvenpää, Finland

Investigational Site Number 2460007; 🇫🇮 Oulu, Finland

Investigational Site Number 2460003; 🇫🇮 Pori, Finland

Investigational Site Number 2460001; 🇫🇮 Tampere, Finland

Investigational Site Number 2460002; 🇫🇮 Turku, Finland

Investigational Site Number 2080003; 🇩🇰 Odense, Denmark

Investigational Site Number 2080001; 🇩🇰 Aarhus, Denmark

Investigational Site Number 2080002; 🇩🇰 Hvidovre, Denmark

Investigational Site Number 2760004; 🇩🇪 Bramsche, Germany

Investigational Site Number 2760009; 🇩🇪 Schweigen, Germany

Investigational Site Number 2760015; 🇩🇪 Bönnigheim, Germany

Investigational Site Number 2760020; 🇩🇪 Herxheim, Germany

Investigational Site Number 2760002; 🇩🇪 Erfurt, Germany

Investigational Site Number 2760007; 🇩🇪 Hürth, Germany

Investigational Site Number 2760003; 🇩🇪 Mönchengladbach, Germany

Investigational Site Number 2760011; 🇩🇪 Mannheim, Germany

Investigational Site Number 2760010; 🇩🇪 Tuttlingen, Germany

Investigational Site Number 2760005; 🇩🇪 Mönchengladbach, Germany

Investigational Site Number 2760008; 🇩🇪 Schwaigern, Germany

Investigational Site Number 2760018; 🇩🇪 Tauberbischofsheim, Germany

Investigational Site Number 2760006; 🇩🇪 Schönau, Germany

Investigational Site Number 2760012; 🇩🇪 Wolfsburg, Germany