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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
576
Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular
Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
Lakeview Clinical Research Site Number : 8400029
Guntersville, Alabama, United States
California Research Foundation Site Number : 8400005
San Diego, California, United States
PAS Research Site Number : 8400032
Tampa, Florida, United States
Brengle Family Medicine Site Number : 8400044
Indianapolis, Indiana, United States
AMR El Dorado Site Number : 8400018
El Dorado, Kansas, United States
Alliance for Multispecialty Research LLC Site Number : 8400013
Wichita, Kansas, United States
Prime Global Research, Inc. Site Number : 8400043
The Bronx, New York, United States
The Research Center of the Upstate Site Number : 8400008
Greenville, South Carolina, United States
Investigational Site Number : 6300003
Ponce, Puerto Rico
Investigational Site Number : 6300001
San Juan, Puerto Rico
Number of participants with immediate adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time frame: Within 30 minutes after vaccination
Number of participants with solicited injection site reactions or systemic reactions
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)
Time frame: Within 7 days after vaccination
Number of participants with unsolicited AEs
AEs that do not fulfill the conditions of solicited reactions
Time frame: Within 30 days after vaccination
Number of participants with serious adverse events (SAEs)
SAEs reported throughout the study, including adverse events of special interest (AESI)s
Time frame: Up to 6 months after last vaccination
Number of participants with medically attended adverse events (MAAE)s
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
Time frame: Up to 6 months after last vaccination
Number of participants with out-of-range biological test results
Out-of-range biological test results occurring in the sentinel cohorts of each age group
Time frame: From baseline (pre-vaccination) up to Day 07 (post-vaccination)
Antibody titers in the primary panel of MenB strains before primary vaccination
Antibody titers measured by serum bactericidal assay using human complement (hSBA)
Time frame: Day 01 (pre-vaccination)
Antibody titers in the primary panel of MenB strains after primary vaccination
Antibody titers measured by hSBA
Time frame: Day 30 (post-vaccination)
Antibody titers in the primary panel of MenB strains after each vaccination
Antibody titers measured by hSBA
Time frame: Day 01, Day 31, Day 61, Day 91, Day 181, Day 211, Day 366 and Day 396
Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only)
Antibody titers measured by hSBA
Time frame: Day 01 (pre-vaccination) and Day 30 (post-vaccination)
Antibody titers in the primary panel of MenB strains (stage 2 only)
Antibody titers measured by hSBA
Time frame: Day 366 (pre-vaccination) and Day 396 (post-vaccination)
Antibody titers against each of Men A, C, W, and Y strains
Antibody titers measured by hSBA in participants receiving MenQuadfi vaccine
Time frame: Day 01 (pre-vaccination) and Day 30 (post-vaccination)
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