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

NCT ID: NCT00822757

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2007-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

V710

Group Type: EXPERIMENTAL

Comparator: V710

Intervention Type: BIOLOGICAL

Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.

2

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: BIOLOGICAL

Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.

Interventions

Comparator: V710

Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.

Intervention Type: BIOLOGICAL

Comparator: placebo

Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.

Reference Type: RESULT

PMID: 22192849 (View on PubMed)

Other Identifiers

2007_531

Identifier Type: -

Identifier Source: secondary_id

V710-004

Identifier Type: -

Identifier Source: org_study_id