Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pneumococcal Conjugate Vaccine · 1 trial · 1 indication
Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.
Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)
Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.
Geometric Mean (GM) of serotype-specific IgG concentrations for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by electro-chemiluminescence (ECL) assay
GM of serotype-specific OPA titers for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by multiplex opsonophagocytic assay (MOPA)
| Arm | Type | Description |
|---|---|---|
| Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I | EXPERIMENTAL | Participants will receive 1 intramuscular injection of PCV formulation SP0202-I |
| Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II | EXPERIMENTAL | Participants will receive 1 intramuscular injection of PCV formulation SP0202-II |
| Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III | EXPERIMENTAL | Participants will receive 1 intramuscular injection of PCV formulation SP0202-III |
| Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV | EXPERIMENTAL | Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV |
| Group 5: Prevnar 13® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pneumococcal Conjugate Vaccine | BIOLOGICAL | Suspension for Intramuscular injection |
| Prevnar 13® | BIOLOGICAL | Suspension for Intramuscular injection |
Inclusion Criteria: * Men or women aged 19 to 49 years on the day of inclusion ("19 to 49 years" means from the day of the 19th birthday to the day before the 50th birthday) * Informed Consent Form (ICF) has been signed and dated * Able to attend all scheduled visits and to comply with all trial pr...
Pneumococcal Conjugate Vaccine is used for pneumococcal immunization, which helps protect against infections caused by Streptococcus pneumoniae bacteria. It is being studied for use in healthy toddlers, infants, and adults to prevent pneumococcal disease.
Sanofi (ticker: SNY) is developing the Pneumococcal Conjugate Vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in different age groups.
Pneumococcal Conjugate Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and immune response.
Pneumococcal Conjugate Vaccine has been studied in two clinical trials. NCT04398706 was a Phase 2 study in toddlers and infants, and NCT06698198 was a Phase 1 study in healthy adults aged 19-49 years. Both trials have been completed.
Pneumococcal Conjugate Vaccine is a specific vaccine candidate developed by Sanofi. It is not referred to by any alternative names in the available data. It is distinct from other pneumococcal vaccines on the market.