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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00822757
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2007-10
• Study Completion: 2007-12
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Results First Submitted: 2011-06-22
• Results First Submitted QC: 2011-10-13
• Results First Posted: 2011-11-21
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).	Prevaccination to 14 days postvaccination	Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).