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Safety and Efficacy of SA4Ag ...

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

Last Updated: 2021-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-02

Study Completion Date

2019-06-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Staphylococcal Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SA4Ag

Staphylococcus aureus 4-antigen Vaccine

Group Type ACTIVE_COMPARATOR

Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine

Intervention Type BIOLOGICAL

SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery

Placebo

Diluent (sterile water) for Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery

Interventions

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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

Intervention Type BIOLOGICAL

Placebo

Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery

Intervention Type OTHER

Other Intervention Names

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Vaccine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Barrow Brain and Spine

Phoenix, Arizona, United States

Site Status

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

Greenbaum Surgical Specialty Hospital

Scottsdale, Arizona, United States

Site Status

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

Site Status

Clinical Office - Jason Cuellar M.D.

Beverly Hills, California, United States

Site Status