Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

NCT ID: NCT00518687

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 8031 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-08-31

Brief Summary

This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.

Conditions

Staphylococcus Aureus; Bacteremia; Mediastinitis

Study Design

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

Study Groups

V710 60 µg

Group Type: EXPERIMENTAL

V710

Intervention Type: BIOLOGICAL

0.5-mL single injection of V710 (60 µg)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.5-mL single injection of matching placebo

Interventions

V710

0.5-mL single injection of V710 (60 µg)

Intervention Type: BIOLOGICAL

Placebo

0.5-mL single injection of matching placebo

Intervention Type: BIOLOGICAL

Other Intervention Names

Merck 0657nI Staphylococcus aureus vaccine

Eligibility Criteria

Inclusion Criteria

• Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination.
• Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Exclusion Criteria

• Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.
• A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.
• Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
• Participant has any type of ventricular-assist device in place at the time of study entry.
• Participant has a history of anaphylaxis to any of the vaccine components.
• Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies.
• Participant has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
• Participant has impairment of the immune system.
• Participant has a medical condition in which the expected survival is less than 90 days.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Fowler VG, Allen KB, Moreira ED, Moustafa M, Isgro F, Boucher HW, Corey GR, Carmeli Y, Betts R, Hartzel JS, Chan IS, McNeely TB, Kartsonis NA, Guris D, Onorato MT, Smugar SS, DiNubile MJ, Sobanjo-ter Meulen A. Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial. JAMA. 2013 Apr 3;309(13):1368-78. doi: 10.1001/jama.2013.3010.

Reference Type: DERIVED

PMID: 23549582 (View on PubMed)

Other Identifiers

2007_523

Identifier Type: OTHER

Identifier Source: secondary_id

V710-003

Identifier Type: -

Identifier Source: org_study_id