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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02388165
First received: March 9, 2015
Last updated: May 18, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Staphylococcal Vaccine
Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official 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 Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Subjects in each vaccine group with postoperative S aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective open posterior spinal fusion procedures with multilevel instrumentation [ Time Frame: 90 DAYS after surgery ]
  • Safety and tolerability of a single vaccination of SA4Ag in adults aged 18 to <86 years undergoing elective open posterior spinal fusion procedures with multilevel instrumentation, by measuring local reactions, systemic events, and AEs. [ Time Frame: Up to 8 months after vaccination ]

Secondary Outcome Measures:
  • Subjects in each vaccine group with postoperative S. aureus BSI and/or deep incisional or organ/space surgical site infections occurring within 180 days of elective open posterior spinal fusion procedures with multilevel instrumentation [ Time Frame: 180 days after surgery ]
  • Subjects in each vaccine group with postoperative S. aureus surgical site infections occurring within 90 days of elective open posterior spinal fusion procedures with multilevel instrumentation. [ Time Frame: 90 days after surgery ]
  • Subjects in each vaccine group with postoperative S. aureus surgical site infections occurring within 180 days of elective open posterior spinal fusion procedures with multilevel instrumentation. [ Time Frame: 180 days after surgery ]

Estimated Enrollment: 2600
Actual Study Start Date: July 2, 2015
Estimated Study Completion Date: November 7, 2018
Estimated Primary Completion Date: August 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SA4Ag
Staphylococcus aureus 4-antigen Vaccine
Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery
Other Name: Vaccine
Placebo Comparator: Placebo
Diluent (sterile water) for Placebo
Other: Placebo
Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be scheduled to undergo an elective open posterior spinal fusion procedures with multilevel instrumentation, 10 to 60 days after study vaccination.
  • Subject must be available for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary for 10 days after study vaccination.
  • Aged 18 to <86 years old

Exclusion Criteria:

  • Planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure).
  • Surgical indication of malignancy, infection or acute or emergency trauma.
  • History of major surgery within 3 months prior to enrollment, or anticipated major surgery other than the Index Surgical Procedure between study enrollment and completion of study participation.
  • History of any spinal surgery performed within 6 months prior to study enrollment.
  • History of any previous spinal surgery resulting in postoperative BSI or SSI.
  • Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies within a year of enrollment or the use of systemic corticosteroids for > 14 days within 30 days prior to enrollment.
  • History of leukemia, lymphoma, underlying bone marrow disorder or history of bone marrow transplant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02388165

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 225 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02388165     History of Changes
Other Study ID Numbers: B3451002
2014-002644-40 ( EudraCT Number )
6123K1-2001 ( Other Identifier: Alias Study Number )
STRIVE ( Other Identifier: Alias Study Number )
Study First Received: March 9, 2015
Last Updated: May 18, 2017

Keywords provided by Pfizer:
Staphylococcal Vaccine
Post-operative Surgical Site Infection
Spinal Surgery
MRSA
Staphylococcus aureus

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017