Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PCV21 vaccine
PCV21 · 7 trials · 4 indications
Unsolicited (spontaneously reported) systemic AEs after injection of a pneumococcal vaccine
SAEs and AESIs are collected throughout the study period
Ab (antibody) concentrations for each pneumococcal serotype measured by electro-chemiluminescence (ECL) assay
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)
Ab (antibody) concentrations for each pneumococcal serotype are measured.
Serotype specific OPA titers for each pneumococcal serotype are determined.
Ab concentrations for each pneumococcal serotype are measured.
Serotype specific OPA titers for each pneumococcal serotype are determined.
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 |
|---|---|---|
| Investigated Vaccine: PCV21 | EXPERIMENTAL | Participants will receive 1 intramuscular injection of the pneumococcal vaccine |
| Comparator Vaccine: 20vPCV | ACTIVE_COMPARATOR | Participants will receive 1 intramuscular injection of the pneumococcal vaccine |
| 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 |
| Infants (7 to 11 MoA) | EXPERIMENTAL | Participants will receive 3 intramuscular injections of pneumococcal vaccine with an interval of: * 4 to 8 weeks (28 to 56 days) between the 1st dose and the 2nd dose * 8 to 12 weeks (56 to 84 days) between the 2nd dose and the 3rd dose AND age ≥ 12 MoA at 3rd dose |
| Toddlers (12 to 23 MoA) | EXPERIMENTAL | Participants will receive 2 intramuscular injections of the pneumococcal vaccine with an interval of 8 to 12 weeks (56 to 84 days) between doses |
| Children/adolescent (2 to 5 and 6 to 17 YoA) | EXPERIMENTAL | Participants will receive 1 intramuscular injection of the pneumococcal vaccine |
| 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 | BIOLOGICAL | Investigational pneumococcal conjugate vaccine |
| 20vPCV | BIOLOGICAL | 20-valent pneumococcal conjugate vaccine |
| 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: AGE * Aged 2 to 17 years on the day of inclusion. TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS * Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record. SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS * A pa...
PCV21 is an investigational 21-valent pneumococcal conjugate vaccine developed by Sanofi. It is designed to immunize against pneumococcal disease and is being studied in healthy infants, children, adolescents, and in children with sickle cell disease. It is currently in Phase 3 clinical development.
PCV21 is being developed for pneumococcal immunization and the prevention of pneumococcal infections. Clinical studies are also evaluating it in children and adolescents with sickle cell disease, a group at elevated risk of pneumococcal illness. All studied uses remain investigational pending Phase 3 results.
PCV21 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is running the Phase 3 clinical program evaluating the vaccine across infant, toddler, child, adolescent, and sickle cell disease populations.
PCV21 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Five Phase 3 trials are listed, all currently active, with no completed trials. Total planned enrollment across these studies is approximately 7,941 participants.
PCV21 is being studied in five Phase 3 trials. These include NCT07348692, a lot-to-lot consistency study in healthy infants; NCT07247188, a single-dose study in children and adolescents with sickle cell disease; NCT06975878 in healthy infants; and NCT06838000, a catch-up vaccination study in infants through adolescents.
Yes. PCV21 and PCV21 vaccine refer to the same Sanofi investigational 21-valent pneumococcal conjugate vaccine. The shorthand PCV21 is used in trial titles such as the catch-up vaccination study NCT06838000, while the full name appears in the other Phase 3 study listings.