Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants

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

Conditions

• Meningococcal Immunisation
• Healthy Volunteers

Interventions

DRUG

Multicomponent Meningococcal B Vaccine

Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular

DRUG

Meningococcal Group B Vaccine MenB

Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular

DRUG

Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)

Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular

DRUG

Placebo

Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular

DRUG

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine

Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

42 Days

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-29

Primary Completion

2022-07-22

Completion

2022-07-22

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations