Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MenPenta
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)...
The Pentavalent Meningococcal ABCYW vaccine is an investigational vaccine developed by Sanofi that is designed to protect against meningococcal disease. It is a pentavalent product, meaning it combines five meningococcal serogroups, A, B, C, Y, and W, into a single vaccine candidate. It is currently in Phase 1 clinical development.
The Pentavalent Meningococcal ABCYW vaccine is being developed for meningococcal immunisation, the prevention of disease caused by meningococcal bacteria. Clinical studies have enrolled healthy volunteers, including adults, adolescents, children, toddlers, and infants, to evaluate the vaccine for this use. It is investigational and has not been approved for use.
Sanofi is developing the Pentavalent Meningococcal ABCYW vaccine. Sanofi is a global pharmaceutical company whose shares trade under the ticker SNY. The vaccine candidate is part of Sanofi's infectious disease pipeline and is being studied in Phase 1 clinical trials.
The Pentavalent Meningococcal ABCYW vaccine is in Phase 1 clinical development. It is an investigational vaccine candidate and is not approved for any indication. Two Phase 1 trials have been conducted, one in adults and adolescents and one in children, toddlers, and infants.
The Pentavalent Meningococcal ABCYW vaccine has been studied in two Phase 1 trials. NCT06128733 evaluated the vaccine in adults and adolescents in the United States and Puerto Rico and is completed. NCT06647407 is evaluating the vaccine in children, toddlers, and infants across nine countries and is active but not recruiting.
Trials of the Pentavalent Meningococcal ABCYW vaccine have enrolled a total of 1,215 participants. The completed Phase 1 study NCT06128733 enrolled 1,215 adults and adolescents, while the ongoing Phase 1 study NCT06647407 has a planned enrollment of 750 children, toddlers, and infants. Both studies are randomized, double-blind, and actively controlled.