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

INTERVENTION: Product Code: PF‐06290510 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: N/A Other descriptive name: CP5‐CRM197 Conjugate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30‐ INN or Proposed INN: N/A Other descriptive name: CP8‐CRM197 Conjugate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30‐ INN or Proposed INN: N/A Other descriptive name: rmClfA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60‐ INN or Proposed INN: N/A Other descriptive name: rP305A Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Lyophilisate for solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Prophylaxis for prevention of Post‐operative S. aureus infection ; MedDRA version: 17.1 Level: PT Classification code 10060945 Term: Bacterial infection System Organ Class: 10021881 ‐ Infections and infestations ; MedDRA version: 17.1 Level: LLT Classification code 10004035 Term: Bacterial infection due to staphylococcus aureus System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] SECONDARY OUTCOME: Secondary end point(s): Secondary Efficacy Endpoints:; ‐ The number of subjects in each vaccine group with postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures.; ‐ The number of subjects in each vaccine group with postoperative S. aureus SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures.; ‐ The number of subjects in each vaccine group with postoperative S. aureus SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures. Timepoint(s) of evaluation of this end point: Various ‐ see protocol PRIMARY OUTCOME: Main Objective: Primary Efficacy Objective; To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures, in adults aged 18 to <86 years.; ; Primary Safety Objective; To describe the safety and tolerability of a single vaccination of SA4Ag in adults aged 18 to <86 years undergoing elective posterior instrumented lumbar spinal fusion procedures, by measuring local reactions, systemic events, and AEs. Primary end point(s): Primary Efficacy Endpoint; The number of subjects in each vaccine group with postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures, as confirmed by the event adjudication committee (EAC).; ; Primary Safety Endpoints; ‐ Number and proportion of subjects in each vaccine group with local reactions (redness, swelling, and pain) occurring within the 10‐day period following study vaccination.; ‐ Number and proportion of subjects in each vaccine group with systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle or joint pain) occurring within the 10‐day period following study vaccination.; ‐ Number and proportion of subjects in each vaccine group with AEs reported during the following time periods:; ‐ From vaccination until the day of surgery; ‐ From vaccination until the Day 42 postoperative evaluation; ‐ From the day of surgery until the Day 42 postoperative evaluation; ‐ From the Day 42 postoperative evaluation until the day 180 postoperative evaluation (newly diagnosed chronic medical disorders); ‐ Number and proportion of subjects in each vaccine group with serious adverse events (SAEs) reported during the following time periods:; ‐ From vaccination until the Day 180 postoperative evaluation; ‐ From vaccination until the day of surgery; ‐ From the day of surgery until the Day 180 postoperative evaluation Secondary Objective: Secondary Efficacy Objectives; ‐ To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus BSI and/or deep incisional or organ/space SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures, in adults 18 to <86 years of age.; ‐ To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus SSI occurring within 90 days of elective posterior instrumented lumbar spinal fusion procedures, in adults 18 to <86 years of age.; ‐ To assess the efficacy of SA4Ag in the prevention of postoperative S. aureus SSI occurring within 180 days of elective posterior instrumented lumbar spinal fusion procedures, in adults 18 to <86 years of age. Timepoint(s) of evaluation of this end point: Various ‐ see protocol INCLUSION CRITERIA: 1. Subject must personally sign and date the informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Subject must be aged 18 to <86 years at the time of enrollment. 3. Subject must be scheduled to undergo an elective posterior instrumented lumbar spinal fusion procedure 10 to 60 days after study vaccination. 4. Subject must be available for the entire duration of the study, and willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including completion of the electronic diary (e‐diary) for 10 days after study vaccination. 5. Subject must be able to be contacted by telephone during study participation. 6. Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. Are the trial subjects under 18? no Number of subject