Phase 3
N=570
Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
Meningococcal Immunisation (Healthy Volunteers)
Bottom Line
View on ClinicalTrials.gov: NCT04084769 ↗Enrolled (actual)
570
Serious AEs
1.1%
Results posted
Aug 2021
Primary outcome: Primary: Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 — 94.8; 97.1; 98.9; 97.7 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 B vaccine (Trumenba®) (Biological); Meningococcal group B vaccine (Bexsero®) (Biological)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 |
94.8; 97.1; 98.9; 97.7 | — |
| PRIMARY Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 |
93.2; 98.9; 100; 98.9 | — |
| SECONDARY Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 |
94.8; 93.2; 97.1; 98.9; 98.9; 100 | — |
| SECONDARY Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 |
91.3; 95.6; 100; 97.8; 97.8; 100 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 |
289; 161; 3799; 919; 1658; 800 | — |
| SECONDARY Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 |
94.8; 93.2; 97.1; 98.9; 98.9; 100 | — |
| SECONDARY Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 |
71.3; 71.0; 99.4; 99.4; 87.9; 50.6 | — |
| SECONDARY GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 |
11.7; 11.5; 502; 399; 36.6; 10.2 | — |
| SECONDARY Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 |
72.3; 71.1; 73.7; 73.1; 86.9; 52.6 | — |
| SECONDARY GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 |
12.3; 12.2; 12.8; 12.7; 34.5; 11.9 | — |
| SECONDARY Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 |
54.5; 35.8; 94.7; 81.2; 18.6; 12.7 | — |
| SECONDARY GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 |
7.28; 5.72; 45.2; 32.8; 12.5; 11.6 | — |
| SECONDARY Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 |
94.8; 93.3; 95.5; 94.4; 97.1; 97.8 | — |
| SECONDARY Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 |
71.3; 73.3; 71.6; 72.5; 99.4; 98.9 | — |
| SECONDARY GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 |
11.7; 12.5; 12.3; 12.4; 502; 593 | — |
Summary
Primary Objective:
To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine:
* In Group 1 participants who were first vaccinated with 1 dose of MenACYW Conjugate vaccine 3-6 years before the booster dose.
* In Group 2 participants who were first vaccinated with 1 dose of Menveo vaccine (meningococcal [Groups A, C, Y and W135] Oligosaccharide Diphtheria CRM197 Conjugate vaccine) 3-6 years before the booster dose.
Secondary Objective:
To describe:
* The vaccine seroresponse, seroprotection (serum bactericidal assay using human complement [hSBA] titer greater than or equal to [>=]1:8), and antibody responses (geometric mean titers [GMTs]) of meningococcal serogroups A, C, Y, and W measured using hSBA in serum specimens collected 6 days (±1 day) after vaccination in a subset of 50 participants per group (Groups 1 and 2).
* The vaccine seroresponse, seroprotection (hSBA titer >=1:8), and antibody responses (GMTs) to serogroups A, C, Y, and W measured using hSBA on Day (D)0 (pre-vaccination) and D30 (+14 days) after vaccination with MenACYW Conjugate vaccine alone (Groups 1 and 2).
* The antibody persistence (GMTs and vaccine seroprotection; hSBA titer >=1:8) of meningococcal serogroups A, C, Y, and W before a booster dose in participants who received either MenACYW Conjugate vaccine or Menveo vaccine 3-6 years earlier.
* The antibody persistence (GMTs and vaccine seroprotection; hSBA titer >=1:8) of meningococcal serogroups A, C, Y, and W in participants who received either a single dose MenACYW Conjugate vaccine (participants randomized to MET59 Groups 1, 3, and 4) or Menveo vaccine (participants assigned to MET59 Group 2), as part of study MET50, or MET43 (participants randomized to MET59 Groups 1, 3 and 4).
* To describe the vaccine seroresponse, seroprotection (hSBA titer >=1:8), and antibody responses (GMTs) to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with meningococcal serogroup B (MenB) vaccine (Groups 3 and 4), compared to those when it was given alone (Group 1).
Eligibility Criteria
Inclusion criteria
- Aged >= 13 to less than ( =18 (or legal age of majority, if different from 18 years of age) to =18 (or legal age of majority, if different from 18 years of age) to = 100.4 degree Fahrenheit). A prospective participant should not be included in the study until the condition had resolved or the febrile event had 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.
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 (NCT04084769). 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.