| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01734239 | A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018) | PHASE3 | COMPLETED | 102 | — | — | Jun 3, 2013 | Oct 22, 2013 | Oct 30, 2018 | - | — |
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A \>=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in \>=4 participants were reported for this endpoint.
A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention
| Arm | Type | Description |
|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | EXPERIMENTAL | Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 |
| Pneumovax™ 23: Participants >=50 Years | EXPERIMENTAL | Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 |
| Name | Type | Description |
|---|---|---|
| Pneumovax™ 23 | BIOLOGICAL | Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F |
Inclusion Criteria: * For participants 50 years of age or older: any underlying chronic illness must be in stable condition * For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chroni...