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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07348692 | Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age | PHASE3 | RECRUITING | 2,195 | — | — | Jan 20, 2026 | May 29, 2028 | May 22, 2026 | 19 | United States, Honduras +1 |
| NCT06975878 | Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age | PHASE3 | ACTIVE NOT_RECRUITING | 1,092 | — | — | May 22, 2025 | Aug 25, 2027 | Mar 2, 2026 | 49 | Belgium, Czechia +6 |
| NCT06824181 | Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age | PHASE3 | ACTIVE NOT_RECRUITING | 580 | — | — | Feb 27, 2025 | Sep 10, 2027 | Feb 13, 2026 | 27 | United States, Chile +2 |
| NCT06824194 | Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age | PHASE3 | ACTIVE NOT_RECRUITING | 2,360 | — | — | Feb 18, 2025 | Oct 22, 2027 | Apr 13, 2026 | 132 | United States, Honduras +4 |
| NCT06736041 | Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age | PHASE3 | ACTIVE NOT_RECRUITING | 1,714 | — | — | Dec 18, 2024 | May 17, 2027 | Apr 22, 2026 | 112 | United States, Australia +4 |
Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
Serotype specific IgG concentration ≥ 0.35 µg/mL
Serotype specific IgG Geometric Mean Concentration (GMC)
Number of participants experiencing solicited and unsolicited immediate AEs
Number of participants experiencing solicited injection site and systemic reactions
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Number of participants experiencing SAEs
Number of participants experiencing AESIs
The GMCs for serotype-specific pneumococcal IgG antibodies are measured using electro-chemiluminescence assay (ECL)
Serotype specific IgG concentration ≥ 0.35 µg/mL
Serotype specific IgG Geometric Mean Concentration (GMC)
| Arm | Type | Description |
|---|---|---|
| Group 1: PCV21 | EXPERIMENTAL | Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
| Group 2: PCV21 | EXPERIMENTAL | Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
| Group 3: PCV21 | EXPERIMENTAL | Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
| Group 4: 20vPCV (Cohort A only) | ACTIVE_COMPARATOR | Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
| Group 2: 15vPCV | ACTIVE_COMPARATOR | Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice |
| Group 1: 20vPCV-PCV21-PCV21-PCV21 | EXPERIMENTAL | Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA |
| Group 2: 20vPCV-20vPCV-PCV21-PCV21 | EXPERIMENTAL | Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA |
| 20vPCV-20vPCV-20vPCV-PCV21 | EXPERIMENTAL | Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA |
| 20vPCV-20vPCV-20vPCV-20vPCV | ACTIVE_COMPARATOR | Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA |
| Group 2: 20vPCV | ACTIVE_COMPARATOR | Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA |
| Name | Type | Description |
|---|---|---|
| PCV21 vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| 20vPCV licensed vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Vaxneuvance vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| Hexyon vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| M-M-RvaxPro vaccine | BIOLOGICAL | Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous |
| Varivax vaccine | BIOLOGICAL | Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous |
| Prevnar 20 vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| M-M-R II vaccine | BIOLOGICAL | Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular |
| Rotarix | BIOLOGICAL | Pharmaceutical form:Solution-Route of administration:Oral |
| RotaTeq | BIOLOGICAL | Pharmaceutical form:Solution-Route of administration:Oral |
| Vaxelis vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| Varivax | BIOLOGICAL | Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular |
| Priorix | BIOLOGICAL | Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous |
| VAQTA | BIOLOGICAL | Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular |
| Havrix | BIOLOGICAL | Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular |
| Hexaxim Vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
Inclusion Criteria: * Aged 42 to 89 days on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period abov...