Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

Phase 2 Terminated 3450 enrolled Pfizer

RandomizedParallel-groupTriple-blindPrevention

Summary

The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.

Timeline

Start: 2015-07-02
Primary completion: 2019-06-26
Completion: 2019-06-27

Outcome

Outcome not reported

Stopped: “Study terminated by sponsor”

Publications

Hassanzadeh H, Baber J, Begier E, Noriega DC, Konishi H, Yato Y, Wang MY, Le Huec JC, Patel V, Varga P, Liljenqvist U, Conly J, Sabharwal C, Munjal I, Cooper D, Radley D, Jaques A, Patton M, Gruber WC, Jansen KU, Anderson AS, Gurtman A; STaphylococcus aureus suRgical Inpatient Vaccine Efficacy Investigator Team. Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial. Clin Infect Dis. 2023 Jul 26;77(2):312-320. doi: 10.1093/cid/ciad218.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	SA4Ag	Vaccine	—	Intramuscular

Indications

No indication recorded.