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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06698198 | Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years) | PHASE1 | COMPLETED | 175 | — | — | Dec 3, 2018 | Sep 30, 2019 | Nov 20, 2024 | 2 | United States |
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...