Phase 3
Completed N=102
A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)
Source: ClinicalTrials.gov NCT01734239 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine — 0.2; 0.2; 4.1; 2.5 ug/mL
Summary
The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine |
0.2; 0.2; 4.1; 2.5; 0.5; 0.6 | — |
| PRIMARY Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine |
96.2; 87.5; 76.9; 89.6; 88.5; 89.6 | — |
| PRIMARY Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) |
1; 0 | — |
| PRIMARY Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants |
16; 5 | — |
| PRIMARY Number of Participants Reporting Serious Adverse Experiences |
0; 0 | — |
Eligibility Criteria
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, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities
- Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination
Exclusion Criteria
- Received prior vaccination with pneumococcal vaccine
- Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids
- Has history of autoimmune disease
- Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination
- Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination
- Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine)
- Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination
- Hospitalized for acute illness within 3 months before study vaccination
- Is a pregnant woman or nursing mother
- History of invasive pneumococcal disease or of other culture-positive pneumococcal disease
- History of fever illness within 3 days before study vaccination
- Received antibiotic therapy for any acute illness within 7 days before study vaccination
- Hypersensitivity to any components of the vaccine, including phenol
Data sourced from ClinicalTrials.gov (NCT01734239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.