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

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ClinicalTrials.gov Identifier: NCT02388165
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE March 13, 2015
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE July 2, 2015
Estimated Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
The number of subjects in each treatment group with postoperative S. aureus blood stream infections and/or deep incisional or organ/space surgical site infections occurring within 90 days of elective posterior instrumented lumbar spinal fusion [ Time Frame: 90 DAYS after surgery ]
Change History Complete list of historical versions of study NCT02388165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
  • The number of subjects in each treatment group with postoperative S. aureus blood stream infections and/or deep incisional or organ/space surgical site infections occurring within 180 days of elective posterior instrumented lumbar spinal fusion [ Time Frame: 180 days after surgery ]
  • The number of subjects in each treatment group with postoperative S. aureus surgical site infections occurring within 90 days of elective posterior instrumented lumbar spinal fusion [ Time Frame: 90 days after surgery ]
  • The number of subjects in each treatment group with postoperative S. aureus surgical site infections occurring within 180 days of elective posterior instrumented lumbar spinal fusion [ Time Frame: 180 days after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Staphylococcal Vaccine
Intervention  ICMJE
  • 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
  • Other: Placebo
    Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery
Study Arms  ICMJE
  • Active Comparator: SA4Ag
    Staphylococcus aureus 4-antigen Vaccine
    Intervention: Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
  • Placebo Comparator: Placebo
    Diluent (sterile water) for Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
3450
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2015)
2600
Estimated Study Completion Date  ICMJE June 26, 2019
Estimated Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bulgaria,   Canada,   France,   Germany,   Hungary,   Japan,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Romania
 
Administrative Information
NCT Number  ICMJE NCT02388165
Other Study ID Numbers  ICMJE B3451002
2014-002644-40 ( EudraCT Number )
6123K1-2001 ( Other Identifier: Alias Study Number )
STRIVE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP