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

Phase 2/3 Terminated 8031 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start: 2007-12
Primary completion: 2011-08
Completion: 2011-08

Outcome

Missed primary endpoint

registry V710 60 µg vs Placebo; p = 0.584; Vaccine Efficacy (VE) 18.5 (95% CI -48.6 to 55.8) NCT00518687 ↗

paper At the end of the study, the V710 vaccine was not significantly more efficacious than placebo in preventing either the primary end points PMID 23549582 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	V710	Vaccine	60 ug	Intramuscular