Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants
- Conditions
- Healthy VolunteersMeningococcal Immunisation
- Interventions
- Drug: PlaceboDrug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
- Registration Number
- NCT04825223
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
Primary Objective:
* To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-4 only), and with age-appropriated routine pediatric vaccines (for Stages 3-4 only)
1. To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents;
2. To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants;
3. To describe the safety profile of the SP MenB vaccine formulations,
* when administered alone
* when administered with MenQuadfiTM (MenACYW conjugate vaccine)
* when administered with routine infant immunizations
* To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines after the last dose of primary vaccination in healthy adults, adolescents, toddlers and infants, when administered alone, or concomitantly with MenQuadfi Vaccine or other routine vaccines, as measured by the serum bactericidal assay using human complement (hSBA) in the primary panel of MenB strains by Stage, by age group and by vaccine schedule
Secondary Objective:
* To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines at each timepoint in healthy adults, adolescents, toddlers and infants, when administered alone or concomitantly with MenQuadfi Vaccine or other routine vaccines as measured by hSBA in the primary panel of MenB strains by Stage by age group and by vaccine schedule
* To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents) in Stage 1 and 2 after the last dose of the primary series in each group
* To describe the persistence of immune response following primary series at D366, and immune response 1 month after a booster dose of the SP MenB vaccine given 1-year post-dose 1 (at D366) in a subset of adults and adolescents in Stage 2 who received SP MenB vaccine formulations, Bexsero Vaccine or Trumenba Vaccine as measured by hSBA in the primary panel of MenB strains by age group
* To describe the immune response against meningococcal serogroups A, C, W and Y measured with hSBA in participants from each agegroup receiving MenQuadfi Vaccine
- Detailed Description
Study duration per participant will be approximately: 7 months for Stage 1 participants, 12 to 18.5 months for Stage 2 participants, 12 months for Stage 3 participants and 18 months for Stage 4 participants
In each vaccine group at each age group (Stage 1, 3 and 4 only), the first 5 participants enrolled (sentinels) will be assessed via early safety data review (ESDR) as a cohort for the evaluation of biological safety and overall safety profile for D01-D08 post dose 1. The safety data collected will be reviewed before proceeding with recruitment of remaining participants in each study group. Enrollment of remaining participants randomized to each group will be based on the outcome of the safety assessments of the sentinels: only a positive review outcome will allow the enrollment of the sentinel cohort of the respective lower age group.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 576
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stage 1: MenB vaccine formulation(s) Placebo Assigned MenB vaccine formulation or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181 Stage 1: vaccine comparator(s) Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181 Stage 2: MenB vaccine formulation(s) Placebo Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366 Stage 1: MenB vaccine formulation(s) Meningococcal Group B Vaccine MenB Assigned MenB vaccine formulation or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181 Stage 1: vaccine comparator(s) Placebo Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181 Stage 1: vaccine comparator(s) Multicomponent Meningococcal B Vaccine Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181 Stage 2: MenB vaccine formulation(s) Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366 Stage 2: vaccine comparator(s) Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366 Stage 4: MenB vaccine formulation(s) Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine Assigned MenB vaccine formulation, Routine Vaccines (RV)s and MenQuadfi vaccine single injection in the respective dosing at 2 months of ages \[moa\] (Day 01), 4moa (Day 61) and 12 moa Stage 4: MenQuadfi vaccine and vaccine comparator Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine MenQuadfi vaccine or Bexsero vaccine and RVs in the respective dosing schedule at 2 months of ages \[moa\] (Day 01), 4moa (Day 61) and 12 moa Stage 2: vaccine comparator(s) Placebo Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366 Stage 2: MenB vaccine formulation(s) Meningococcal Group B Vaccine MenB Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366 Stage 3: Men B vaccine formulation(s) Meningococcal Group B Vaccine MenB Assigned MenB vaccine formulation and/or MenQuadfi vaccine single injection in the respective dosing schedule at Day 01 and Day 61 Stage 3: Men B vaccine formulation(s) Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine Assigned MenB vaccine formulation and/or MenQuadfi vaccine single injection in the respective dosing schedule at Day 01 and Day 61 Stage 4: MenQuadfi vaccine and vaccine comparator Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) MenQuadfi vaccine or Bexsero vaccine and RVs in the respective dosing schedule at 2 months of ages \[moa\] (Day 01), 4moa (Day 61) and 12 moa Stage 3: MenQuadfi vaccine and vaccine comparator Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) MenQuadfi vaccine single injection at Day 01 or Bexsero vaccine single injection at Day 01 and Day 61 Stage 3: MenQuadfi vaccine and vaccine comparator Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine MenQuadfi vaccine single injection at Day 01 or Bexsero vaccine single injection at Day 01 and Day 61 Stage 2: vaccine comparator(s) Multicomponent Meningococcal B Vaccine Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366 Stage 4: MenB vaccine formulation(s) Meningococcal Group B Vaccine MenB Assigned MenB vaccine formulation, Routine Vaccines (RV)s and MenQuadfi vaccine single injection in the respective dosing at 2 months of ages \[moa\] (Day 01), 4moa (Day 61) and 12 moa
- Primary Outcome Measures
Name Time Method Number of participants with immediate adverse events (AEs) Within 30 minutes after vaccination Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with unsolicited AEs Within 30 days after vaccination AEs that do not fulfill the conditions of solicited reactions
Number of participants with serious adverse events (SAEs) Up to 6 months after last vaccination SAEs reported throughout the study, including adverse events of special interest (AESI)s
Number of participants with medically attended adverse events (MAAE)s Up to 6 months after last vaccination AEs with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department
Antibody titers in the primary panel of MenB strains after primary vaccination Day 30 (post-vaccination) Antibody titers measured by hSBA
Number of participants with solicited injection site reactions or systemic reactions Within 7 days after vaccination Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, erythema and swelling (or tenderness, erythema and swelling for infants and toddlers) Systemic reactions: fever, headache, malaise, myalgia (or fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability for infants and toddlers)
Antibody titers in the primary panel of MenB strains before primary vaccination Day 01 (pre-vaccination) Antibody titers measured by serum bactericidal assay using human complement (hSBA)
Number of participants with out-of-range biological test results From baseline (pre-vaccination) up to Day 07 (post-vaccination) Out-of-range biological test results occurring in the sentinel cohorts of each age group
- Secondary Outcome Measures
Name Time Method Antibody titers in the primary panel of MenB strains after each vaccination Day 01, Day 31, Day 61, Day 91, Day 181, Day 211, Day 366 and Day 396 Antibody titers measured by hSBA
Antibody titers in the primary panel of MenB strains (stage 2 only) Day 366 (pre-vaccination) and Day 396 (post-vaccination) Antibody titers measured by hSBA
Antibody titers against each of Men A, C, W, and Y strains Day 01 (pre-vaccination) and Day 30 (post-vaccination) Antibody titers measured by hSBA in participants receiving MenQuadfi vaccine
Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only) Day 01 (pre-vaccination) and Day 30 (post-vaccination) Antibody titers measured by hSBA
Trial Locations
- Locations (22)
California Research Foundation Site Number : 8400005
🇺🇸San Diego, California, United States
Lakeview Clinical Research Site Number : 8400029
🇺🇸Guntersville, Alabama, United States
Hope Clinical Research, Inc. Site Number : 8400001
🇺🇸Canoga Park, California, United States
WCCT Global, Inc. Site Number : 8400015
🇺🇸Cypress, California, United States
MD Clinical Site Number : 8400027
🇺🇸Hallandale Beach, Florida, United States
Brengle Family Medicine Site Number : 8400044
🇺🇸Indianapolis, Indiana, United States
AMR El Dorado Site Number : 8400018
🇺🇸El Dorado, Kansas, United States
Kentucky Pediatric Research Inc Site Number : 8400009
🇺🇸Bardstown, Kentucky, United States
Progressive Clinical Research Site Number : 8400028
🇺🇸Bountiful, Utah, United States
Alliance for Multispecialty Research LLC Site Number : 8400013
🇺🇸Wichita, Kansas, United States
AMR Wichita East Site Number : 8400012
🇺🇸Wichita, Kansas, United States
Investigational Site Number : 6300001
🇵🇷San Juan, Puerto Rico
Pediatric Clinical Trials Tullahoma Site Number : 8400020
🇺🇸Tullahoma, Tennessee, United States
Investigational Site Number : 6300003
🇵🇷Ponce, Puerto Rico
Advanced Clinical Research - Magic View Site Number : 8400024
🇺🇸Meridian, Idaho, United States
The Research Center of the Upstate Site Number : 8400008
🇺🇸Greenville, South Carolina, United States
Moore Clinical Research Inc Site Number : 8400030
🇺🇸Tampa, Florida, United States
PAS Research Site Number : 8400032
🇺🇸Tampa, Florida, United States
SIMEDHealth, LLC Site Number : 8400045
🇺🇸Gainesville, Florida, United States
AMR Lexington Site Number : 8400002
🇺🇸Lexington, Kentucky, United States
Michael W. Simon, MD, PSC Site Number : 8400026
🇺🇸Lexington, Kentucky, United States
Prime Global Research, Inc. Site Number : 8400043
🇺🇸Bronx, New York, United States