Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants

INTERVENTION: Product Name: Multicomponent Meningococcal B Vaccine Product Code: 527 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Recombinant Neisseria meningitidis serogroup B protein Other descriptive name: RNmB1 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50 ‐ INN or Proposed INN: Recombinant Neisseria meningitidis serogroup B protein 2 Other descriptive name: RNmB2 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50 ‐ INN or Proposed INN: Recombinant Neisseria meningitidis serogroup B protein 3 Other descriptive name: RNmB3 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: Neisseria meningitidis serogroup B Protein based active substance Other descriptive name: NmBPbAS1 Concentration unit: µg microgram(s) Concentration type: range Concentration number: 25‐125 Pharmaceutical form of the placebo: Solution for injection in vial Route of administration of the placebo: Intramuscular use Trade Name: Trumenba Product Name: Trumenba Pharmaceutical Form: Suspension for injection INN or Proposed INN: Neisseria meningitidis serogroup B fHbp subfamily A Other descriptive name: NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY A Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60 ‐ INN or Proposed INN: Neisseria meningitidis serogroup B fHbp subfamily B Other descriptive name: NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY B Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60 ‐ Pharmaceutical form of the placebo: Solution for injection in vial Route of administration of the placebo: Intramuscular use Trade Name: Bexsero (Meningococcal group B Vaccine (rDN CONDITION: Invasive Meningococcal Disease (IMD) ; MedDRA version: 20.0 Level: PT Classification code 10076061 Term: Meningococcal immunisation System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main 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); • 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. Primary end point(s): 1 ‐ Number of participants with immediate adverse events (AEs) ; Unsolicited systemic AEs that occur within 30 minutes after vaccination; 2 ‐ 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); 3 ‐ Number of participants with unsolicited AEs ; AEs that do not fulfill the conditions of solicited reactions; 4 ‐ Number of participants with serious adverse events (SAEs) ; SAEs reported throughout the study, including adverse events of special interest (AESI)s; 5 ‐ 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; 6 ‐ 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; 7 ‐ Antibody titers in the primary panel of MenB strains before primary vaccination ; Antibody titers measured by serum bactericidal assay using human complement (hSBA); 8 ‐ Antibody titers in the primary panel of MenB strains after primary vaccination ; Antibody titers measured by hSBA 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; • To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents); • 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; Timepoint(s) of evaluation of this end point: 1 ‐ Within 30 minutes after vaccination; 2 ‐ Within 7 days after vaccination; 3 ‐ Within 30 days after vaccination; 4 ‐ Up to 6 months after last vaccination; 5 ‐ Up to 6 months after last vaccination; 6 ‐ From baseline (pre‐vaccination) up to Day 07 (post‐vaccination); 7 ‐ Day 01 (pre‐vaccination) ; 8 ‐ Day 30 (post‐vaccination) SECONDARY OUTCOME: Secondary end point(s): 1 ‐ Antibody titers in the primary panel of MenB strains after each vaccination ; Antibody titers measured by hSBA; 2 ‐ Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only) ; Antibody titers measured by hSBA; 3 ‐ Antibody titers in the primary panel of MenB strains (stage 2 only) ; Antibody titers measured by hSBA; 4 ‐ Antibody titers against each of Men A, C, W, and Y strains ; Antibody titers measured by hSBA in participants receiving MenQuadfi vaccine Timepoint(s) of evaluation of this end point: 1 ‐ Day 01, Day 31, Day 61, Day 91, Day 181, Day 211, Day 366 and Day 396; 2 ‐ Day 01 (pre‐vaccination) and Day 30 (post‐vaccination); 3 ‐ Day 366 (pre‐vaccination) and Day 396 (post‐vaccination); 4 ‐ Day 01 (pre‐vaccination) and Day 30 (post‐vaccination) INCLUSION CRITERIA: ‐ For US: Aged 10 to 25 years on the day of inclusion (“10‐25 years” means from the day of the 10th birthday to the day before the 26th birthday) ‐ For EU: Aged 42 to 89 days or 12 to 18 months or 10 to 50 years on the day of inclusion (“42 to 89 days” means from 42 days after birth to the 89th day after birth; “12‐18 months” means from the12th month after birth to the day before the 19th month after birth; “10‐50 years” means from the day of the 10th birthday to the day before the 51st birthday ‐ Participants or participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures ‐ Covered by health insurance (applicable depending on local regulations) ‐ Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator ‐ For adults: A female participant is eligible to participate if she is n