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| ID | Type | Description | Link |
|---|---|---|---|
| PSK00007 | Other Identifier | Sanofi | |
| U1111-1210-0812 | Registry Identifier | ICTRP |
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This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal Conjugate Vaccine | Biological | Suspension for Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection | Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13. | Up to 30 minutes post-vaccination |
| Occurrence of solicited injection site and systemic reactions | Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills) | Up to 7 days post-vaccination |
| Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection | Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13. | Up to 30 days after vaccination |
| Serotype-specific immunoglobulin type G (IgG) concentrations | 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 | Up to 30 days after vaccination |
| Serotype-specific opsonophagocytic activity (OPA) titers | 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) | Up to 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific IgG concentrations ratio (post/pre-vaccination) | GM of serotype-specific IgG concentrations ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL assay | Up to 30 days after vaccination |
| ≥ 4-fold serotype-specific IgG concentrations increase |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 0002 | Metairie | Louisiana | 70427 | United States | ||
| Investigational Site Number: 0001 |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Prevnar 13® | Biological | Suspension for Intramuscular injection |
|
Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to 1 month post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL |
| Up to 30 days after vaccination |
| Serotype-specific OPA titers ratio (post/pre-vaccination) | GM of serotype-specific OPA titers ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA | Up to 30 days after vaccination |
| ≥ 4-fold serotype-specific OPA titers increase | Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA | Up to 30 days after vaccination |
| Newark |
| New Jersey |
| 07103 |
| United States |
| D045424 |
| Complex Mixtures |