Phase 4
Completed N=243
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
Pneumococcal Infection
Source: ClinicalTrials.gov NCT02260882 ↗
Enrolled (actual)
243
Serious AEs
1.7%
Results posted
Feb 2016
Primary outcomePrimary: Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination — 2.72; 2.27; 2.40 Geometric Mean Fold Rise — p=<0.001
Summary
The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination |
2.72; 2.27; 2.40 | <0.001 sig |
| SECONDARY Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination |
4.01; 5.83; 6.11 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Injection-site Erythema |
35.4; 14.8 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Injection-site Swelling |
38.5; 17.3 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Injection-site Pain |
62.7; 46.9 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Pyrexia |
6.8; 1.2 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Myalgia |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Arthralgia |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Headache |
1.9; 1.2 | — |
| SECONDARY Percentage of Participants With an Adverse Event of Fatigue |
1.2; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese participant
- Good health or any underlying chronic illness is documented to be in stable condition
- Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study
- Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion Criteria:
- Known allergy or sensitivity to any of the components of the study vaccine
- History of pneumococcal conjugate vaccination
- Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible
- Functional or anatomic asplenia
- Received immunoglobulin within 6 months before study vaccine or is planned during the study
- Received any investigational drugs or vaccines within 2 months before study vaccination
- History of pneumococcal disease (positive culture from blood or other normally sterile site)
- Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- History of convulsion
- Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency
- Participating in any other clinical trial
Data sourced from ClinicalTrials.gov (NCT02260882). 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.