Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PCV21
PCV21 vaccine · 5 trials · 2 indications
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...
PCV21 is an investigational 21-valent pneumococcal conjugate vaccine being developed for pneumococcal immunization and the prevention of pneumococcal infections. It is also being studied in children and adolescents with sickle cell disease, a population at increased risk for pneumococcal disease.
PCV21 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The vaccine is currently in Phase 3 clinical development for pneumococcal immunization and related indications.
PCV21 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. All five of its clinical trials are active, with four currently recruiting or active but not recruiting participants across multiple countries.
PCV21 is being evaluated in five Phase 3 trials, including NCT06824194 in healthy infants, NCT06838000 as catch-up vaccination in infants through adolescents, NCT06975878 in healthy infants, and NCT07247188 in children with sickle cell disease. These trials are enrolling participants in the United States, Europe, and other regions.
Yes, PCV21 is also known as PCV21 vaccine. Both names refer to the same investigational 21-valent pneumococcal conjugate vaccine being developed by Sanofi for the prevention of pneumococcal infections and immunization.
PCV21 is a pneumococcal conjugate vaccine designed to elicit an immune response against 21 serotypes of Streptococcus pneumoniae bacteria. By presenting these bacterial components to the immune system, the vaccine aims to generate protective antibodies that can prevent pneumococcal infections.