Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06647407 | Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants | PHASE1 | ACTIVE NOT_RECRUITING | 750 | — | — | Nov 5, 2024 | May 17, 2027 | Jan 20, 2026 | 39 | Brazil, Czechia +7 |
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
| 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 |
| 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) |
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)...