Safety and efficacy of SA4Ag vaccine in lumbar spinal fusion
Research type
Research Study
Full title
A phase 2b, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Staphylococcus aureus 4-antigen vaccine (SA4Ag) in adults undergoing elective posterior instrumented lumbar spinal fusion procedures.
IRAS ID
171363
Contact name
Irfan Siddique
Contact email
Sponsor organisation
Pfizer Inc,
Eudract number
2014-002644-40
Duration of Study in the UK
0 years, 11 months, 16 days
Research summary
Staphylococcus aureus is one of the most dominant pathogens (organisms that cause infections) responsible for healthcare related infections. Populations at-risk of developing this infection include patients undergoing surgery, patients with end-stage renal disease, patients in intensive care units (ICUs), transplant recipients, etc. Despite efforts to develop specific preventive and therapeutic measures against this pathogen, postoperative S. aureus infection remains a common and serious occurrence.
Staphylococcus aureus 4-Antigen Vaccine (SA4Ag), is the investigational drug in this clinical trial. About 2600 participants are expected to be enrolled into the study. All eligible participants will be randomized (randomly allocated to a group) to receive a single injection of SA4Ag (investigational product) or placebo (study drug like substance with no medicinal value) at Visit 1 (-60 to -10 days prior to the day of surgery). There will be 5 scheduled study visits and 1 scheduled telephone contact during 6 to 8 months of subject participation.
The main objective of the study is to assess the efficacy of SA4Ag in the prevention of postoperative Staphylococcus aureus occurring within 90 days of elective lumbar spinal fusion procedures, in adults aged 18 to <86 years. The study will also describe the safety and tolerability of a single vaccination of SA4Ag in this age group undergoing elective lumbar spinal fusion procedures, by measuring local reactions, systemic events (fatigue, headache, muscle pain, or joint pain), and adverse events (any unpleasant medical event).
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/0402
Date of REC Opinion
22 Apr 2015
REC opinion
Further Information Favourable Opinion