NCT01324440

Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)

A Randomized, Multicenter, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With Merck Aluminum Adjuvant or Without Merck Aluminum Adjuvant in Healthy Adults 18 to 70 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).

Conditions

• Staphylococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	V710 (30 µg) with MAA	Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly
BIOLOGICAL	V710 (30 µg) without MAA	Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2011-03-29
• Last updated: 2015-04-10
• Results posted: 2011-10-17