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Also known as PCV21 vaccine
PCV21 · 2 trials · 2 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
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.
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| PCV21 | BIOLOGICAL | Investigational pneumococcal conjugate vaccine |
| 20vPCV | BIOLOGICAL | 20-valent pneumococcal conjugate vaccine |
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 being studied for pneumococcal immunization and prevention of pneumococcal infections. It is also being evaluated in the context of sickle cell disease. The vaccine is designed for use in infants, toddlers, children, and adolescents, with clinical trials enrolling healthy participants from approximately 2 months of age.
PCV21 is being developed by Sanofi, a company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting Phase 3 clinical trials to evaluate the vaccine's safety and immunogenicity in various age groups, from infants to adolescents.
PCV21 is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Sanofi is conducting multiple Phase 3 trials to assess the vaccine's safety and immunogenicity in healthy infants, toddlers, children, and adolescents.
PCV21 is being studied in several Phase 3 trials, including NCT06824181, NCT06824194, NCT06838000, and NCT06975878. These trials evaluate mixed vaccination schedules, safety, and catch-up vaccination in healthy participants from about 2 months of age, with enrollment ranging from 580 to 2,360 participants across multiple countries.
Yes, PCV21 and PCV21 vaccine refer to the same investigational pneumococcal conjugate vaccine being developed by Sanofi. The vaccine is currently in Phase 3 clinical trials for pneumococcal immunization and prevention of pneumococcal infections in infants, children, and adolescents.
PCV21 is a 21-valent pneumococcal conjugate vaccine, meaning it is designed to target 21 types of pneumococcal bacteria. As a conjugate vaccine, it links pneumococcal polysaccharides to a carrier protein to enhance the immune response, helping the body produce antibodies against these bacterial strains to prevent pneumococcal infections.