Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pentavalent Meningococcal ABCYW vaccine · 2 trials · 3 indications
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF
Unsolicited AEs other than solicited reactions
SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study
hSBA titers ≥ 1:8 post-vaccination (post-second and third dose)
Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ
Geometric mean titers (pre-dose and post-second and third dose)
hSBA titers ≥ 1:4 for reference MenB strains
hSBA titers ≥ 1:8 for reference MenB strains
Seroresponse defined as a 4-fold increase in hSBA titers
Geometric mean titers (pre-dose and post-second dose) for the reference MenB strains
hSBA titers ≥ 1:8 for serogroups A, C, W, and Y
Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ
Seroresponse defined as a 4-fold increase in hSBA titers
Unsolicited systemic AEs that occur within 30 minutes after vaccination
An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or Emergency Department
Seroresponse defined as post-second vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or post-second vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than or equal to the lower limit of quantification (LLOQ)
hSBA titers ≥ 1:8
Geometric mean titers
Seroresponse defined as a 4-fold increase in hSBA titers
hSBA titers ≥ 1:4 for reference MenB strains
hSBA titers ≥ 1:8 for reference MenB strains
Geometric mean titers for the reference MenB strains
| Arm | Type | Description |
|---|---|---|
| Stage 1: MenPenta vaccine formulation 1 | EXPERIMENTAL | MenPenta vaccine formulation 1, children 2-9 years of age |
| Stage 1: MenPenta vaccine formulation 2 | EXPERIMENTAL | MenPenta vaccine formulation 2, children 2-9 years of age |
| Stage 1: vaccine comparator(s) | ACTIVE_COMPARATOR | Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age |
| Stage 2: MenPenta vaccine formulation 1 | EXPERIMENTAL | MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age |
| Stage 2: MenPenta vaccine formulation 2 | EXPERIMENTAL | MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age |
| Stage 2: vaccine comparator(s) | ACTIVE_COMPARATOR | Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age |
| Stage 3: MenPenta vaccine formulation 1 | EXPERIMENTAL | MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age |
| Stage 3: MenPenta vaccine formulation 2 | EXPERIMENTAL | MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age |
| Stage 3: vaccine comparator(s) | ACTIVE_COMPARATOR | Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age |
| Group 1: MenPenta Formulation 1 | EXPERIMENTAL | Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo |
| Group 2: MenPenta Formulation 2 | EXPERIMENTAL | Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo |
| Group 3: Bexsero® + Menveo® | ACTIVE_COMPARATOR | Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine |
| Group 4: Trumenba® + Menveo® | ACTIVE_COMPARATOR | Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine |
| Group 5: MenQuadfi® | ACTIVE_COMPARATOR | Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo |
| Group 6: Sanofi MenB | EXPERIMENTAL | Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo |
| Group 7: PENBRAYA | ACTIVE_COMPARATOR | Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo |
| Name | Type | Description |
|---|---|---|
| Pentavalent Meningococcal ABCYW vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM) |
| MenACYW conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM) |
| Meningococcal group B vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM) |
| Paracetamol | DRUG | Pharmaceutical form:Suspension-Route of administration:oral |
| DTap-HepB-IPV-Hib vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM) |
| Rotavirus vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM) |
| Pneumococcal 13-valent conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM) |
| Placebo | BIOLOGICAL | Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM) |
| MenABCYW conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM) |
Inclusion Criteria: * Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion * For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (\> 28 weeks)...
Pentavalent Meningococcal ABCYW vaccine is an investigational vaccine being studied for meningococcal immunization in adults, adolescents, children, toddlers, and infants. It is designed to protect against meningococcal disease caused by serogroups A, B, C, W, and Y. The vaccine is currently in Phase 1 clinical development.
Sanofi (ticker: SNY) is developing Pentavalent Meningococcal ABCYW vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity across different age groups, from infants to adults.
Pentavalent Meningococcal ABCYW vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 1 trials have been conducted or are ongoing to assess its safety and immune response.
Pentavalent Meningococcal ABCYW vaccine has been studied in two Phase 1 trials. NCT06128733, completed in the United States and Puerto Rico, enrolled 1,215 adults and adolescents. NCT06647407, active but not recruiting, is evaluating the vaccine in children, toddlers, and infants across multiple countries including Brazil, Czechia, and Germany.
Pentavalent Meningococcal ABCYW vaccine is a distinct investigational vaccine targeting five meningococcal serogroups: A, B, C, W, and Y. It is being developed separately from existing meningococcal vaccines and is currently in early-stage clinical trials to evaluate its safety and immunogenicity.