Phase 1 Completed N=51 Randomized Double-blind Prevention

Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)

Healthy

Source: ClinicalTrials.gov NCT00822757 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2011

Primary outcomePrimary: Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg). — 5.3; 1.0 Ratio

Summary

This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).	5.3; 1.0	—

Eligibility Criteria

Inclusion Criteria

18 to 80 years of age
Good physical health based upon medical history and physical examination
Willing and able to participate in the entire study duration
Female subject with a negative urine pregnancy test immediately prior to study vaccination

Exclusion Criteria

Chronic skin infections or a chronic skin condition (e.g. psoriasis)
Serious S. aureus infection in the last 12 months
Allergy to aluminum-containing substance taken in the body or to any other vaccine component
Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days
Participation in a prior V710 vaccine clinical study
Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00822757). 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.