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
:
Recruiting
First Posted
: March 13, 2015
Last Update Posted
: April 17, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Staphylococcal Vaccine | Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (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 |
Actual Study Start Date : | July 2, 2015 |
Estimated Primary Completion Date : | August 16, 2019 |
Estimated Study Completion Date : | August 16, 2019 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388165
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |

Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 ) |
First Posted: | March 13, 2015 Key Record Dates |
Last Update Posted: | April 17, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
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 |