Phase 1
Completed N=40
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
Staphylococcal Infection
Source: ClinicalTrials.gov NCT00735839 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level — 4.4; 0.9 Ratio
Summary
This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level |
4.4; 0.9 | — |
| PRIMARY Number of Participants With Vaccine-related Serious Adverse Experiences |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Generally Good Physical Health
Exclusion Criteria
- Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before
- Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours
Data sourced from ClinicalTrials.gov (NCT00735839). 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.