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)
- Conditions
- Meningococcal Immunisation (Healthy Volunteers)
- Interventions
- Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccineBiological: Meningococcal Group B vaccine (Trumenba®)Biological: Meningococcal group B vaccine (Bexsero®)
- Registration Number
- NCT04084769
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief 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).
- Detailed Description
Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration, respectively.
Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) throughout the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 570
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4: MenACYW Conjugate vaccine + Bexsero vaccine Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). Group 1: MenACYW Conjugate vaccine Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 (NCT02199691) or MET43 (NCT02842853), received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Meningococcal Group B vaccine (Trumenba®) Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). Group 4: MenACYW Conjugate vaccine + Bexsero vaccine Meningococcal group B vaccine (Bexsero®) Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
- Primary Outcome Measures
Name Time Method 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 Day 30 (post-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
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 Day 30 (post-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
- Secondary Outcome Measures
Name Time Method 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 Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
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 Day 6 (post-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 Day 0 (pre-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 Day 0 (pre-vaccination) in study MET59 GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
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 Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
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 Day 6 (post-vaccination) in study MET59 GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
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 Day 30 (post-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.
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 Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer \>=1:8.
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 Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59 GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
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 Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
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 Day 30 (post-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.
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 Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
Trial Locations
- Locations (30)
Investigational Site Number 8400002
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 8400004
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 8400012
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8400005
🇺🇸San Diego, California, United States
Investigational Site Number 8400033
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 8400013
🇺🇸Bardstown, Kentucky, United States
Investigational Site Number 8400034
🇺🇸Bridgeton, Missouri, United States
Investigational Site Number 8400027
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 8400028
🇺🇸South Euclid, Ohio, United States
Investigational Site Number 8400030
🇺🇸Dayton, Ohio, United States
Investigational Site Number 8400038
🇺🇸Erie, Pennsylvania, United States
Investigational Site Number 8400039
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 8400009
🇺🇸Norman, Oklahoma, United States
Investigational Site Number 8400018
🇺🇸Kingsport, Tennessee, United States
Investigational Site Number 8400029
🇺🇸Tullahoma, Tennessee, United States
Investigational Site Number 8400031
🇺🇸Kaysville, Utah, United States
Investigational Site Number 8400001
🇺🇸Layton, Utah, United States
Investigational Site Number 8400040
🇺🇸Orem, Utah, United States
Investigational Site Number 8400014
🇺🇸Layton, Utah, United States
Investigational Site Number 8400011
🇺🇸Provo, Utah, United States
Investigational Site Number 8400023
🇺🇸Roy, Utah, United States
Investigational Site Number 8400003
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 8400007
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 8400015
🇺🇸South Jordan, Utah, United States
Investigational Site Number 8400036
🇺🇸South Jordan, Utah, United States
Investigational Site Number 8400024
🇺🇸West Jordan, Utah, United States
Investigational Site Number 8400032
🇺🇸Syracuse, Utah, United States
Investigational Site Number 8400037
🇺🇸Charlottesville, Virginia, United States
Investigational Site Number 6300001
🇵🇷San Juan, Puerto Rico
Investigational Site Number 8400022
🇺🇸Salt Lake City, Utah, United States