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

Phase 1

• Conditions: Prophylaxis for prevention of Post-operative S. aureus infection; MedDRA version: 17.1Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: LLTClassification code 10004035Term: Bacterial infection due to staphylococcus aureusSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-002644-40-ES
• Lead Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2600

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 subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

1. Planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure).
2. Surgical indication of malignancy, infection, or acute or emergency trauma.
3. History of major surgery (specifically, an open procedure that enters a body cavity, organ, or joint space) within 3 months prior to enrollment, or anticipated major surgery other than the index surgical procedure between study enrollment and completion of study participation.
4. History of any spinal surgery performed within 6 months prior to study enrollment.
5. History of any previous spinal surgery resulting in postoperative BSI or SSI.
6. Congenital or acquired immunodeficiency disorder, rheumatologic disorder, or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment or the use of systemic corticosteroids (equivalent of ?10 mg/day of prednisone) for >14 days within 30 days prior to study enrollment.
7. History of leukemia, lymphoma, or underlying bone marrow disorder (eg,
myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant.
8. Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment.
9. Any known or suspected malignancy to the spine.
10. Congenital, functional, or surgical asplenia.
11. End-stage renal disease (defined as requiring or anticipating requirement for hemodialysis, peritoneal dialysis, or renal transplant) or nephrotic syndrome.
12. Any contraindication to vaccination or vaccine components, including history of anaphylactic reaction to any vaccine or vaccine-related component.
13. Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 6 months prior to study enrollment OR anticipated receipt of blood products or immunoglobulins (including monoclonal antibodies) prior to the index hospital admission.
14. Previous administration of S. aureus vaccine or S. aureus/Candida vaccine.
15. Antibiotic therapy for microbiologically confirmed ISA disease within 12 months prior to enrollment.
16. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or anticipated participation during the study.
17. Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception, for the duration of the study.
18. Presence of a colostomy, urostomy, tracheostomy, percutaneous gastrostomy tube, indwelling vascular, or urinary catheter; OR anticipated presence of a colostomy, urostomy, tracheostomy, percutaneous gastrostomy tube, indwelling vascular, or urinary catheter prior to the index hospital admission.
19. Other severe acute or chronic medical or psychiatric condition (including drug and alcohol dependencies) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
20. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects wh

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified