Phase 3
N=463
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
Meningococcal Immunisation · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT04490018 ↗Enrolled (actual)
463
Serious AEs
0.2%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2 — 97.5; 92.5; 100; 95.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) (Biological); Meningococcal group A, C, W-135, and Y conjugate vaccine (Biological); Human Papillomavirus 9-valent Vaccine (9vHPV) (Biological); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV) (Biological)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2 |
97.5; 92.5; 100; 95.0; 100; 98.8 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W |
6.95; 6.41; 7.38; 78.2; 56.0; 42.2 | — |
| SECONDARY Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W |
94.3; 88.1; 83.9; 56.3; 50.6; 58.9 | — |
| SECONDARY Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W |
88.0; 76.1; 65.2; 99.4; 91.9; 97.3 | — |
| SECONDARY Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W |
88.0; 75.5; 63.4; 99.4; 88.8; 97.3 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2 |
7.30; 7.06; 4222; 2361 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2 |
6.51; 3.32; 19760; 7052 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 |
25.5; 18.4; 17.3; 16.1; 0.200; 0.215 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 |
94.7; 109; 3135; 3266; 227; 234 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 |
11.9; 12.3; 58.4; 59.3; 47.3; 58.3 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 |
0.708; 34.5; 0.256; 2.91 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 |
146; 1593; 225; 2950; 221; 3166 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 |
8.77; 41.4; 44.5; 146; 11.4; 236 | — |
| SECONDARY Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 |
0.677; 0.876; 18.5; 18.1; 32.9; 29.5 | — |
| SECONDARY Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 |
48.7; 11.4; 10.9; 13.1; 14.3; 4.72 | — |
| SECONDARY Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 |
100; 100; 100; 98.0; 100; 100 | — |
| SECONDARY Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 |
96.5; 38.9; 100; 100; 85.0; 9.7 | — |
| SECONDARY Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens |
81.4; 83.0; 76.1; 74.8; 76.2; 70.8 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 |
2.30; 2.03; 73.9; 64.8; 1.11; 1.08 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 |
2.12; 50.6; 1.07; 36.3; 2.02; 146 | — |
| SECONDARY Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 |
32.0; 31.9; 39.0; 36.5; 96.6; 80.8 | — |
| SECONDARY Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 |
23.9; 33.9; 71.9; 20.8; 23.1; 14.9 | — |
| SECONDARY Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine |
87.8; 88.4; 85.0; 99.3; 97.3; 97.3 | — |
| SECONDARY Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Reporting Solicited Injection Site Reactions |
91; 69; 19; 11; 17; 12 | — |
| SECONDARY Number of Participants Reporting Solicited Systemic Reactions |
12; 11; 6; 75; 64; 52 | — |
| SECONDARY Number of Participants Reporting Unsolicited Adverse Events (AEs) |
69; 49; 37; 49; 31; 37 | — |
| SECONDARY Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) |
0; 1; 0; 0; 0; 0 | — |
Summary
Primary Objective:
To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement [hSBA] titer greater than or equal to [>=] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2).
Secondary Objective:
To describe:
* the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine [adsorbed, reduced antigen(s) content] (Tdap-IPV) vaccines (Group 3).
* the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status.
* the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination.
* the safety profile in each group after each and any vaccination.
Eligibility Criteria
Inclusion Criteria
- Aged 10 to 17 years on the day of inclusion ('10 to 17 years' means from the day of the 10th birthday to the day before the 18th birthday).
- Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infancy (less than [ = 38.0 degree Celsius [>= 100.4 degree Fahrenheit]). A prospective participant should not be included in the study until the condition had resolved or the febrile event has subsided.
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- Participant at high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT04490018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.