Trial · NCT02388165
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
NCT02388165, Phase 2, Terminated, Pfizer; results first posted 2020-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation. Trials, record NCT02388165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02388165
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
- NCT number
- NCT02388165
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3,450 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Staphylococcal Vaccine
- Interventions
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine, Placebo
- First posted
- 2015-03-13
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2014-002644-40
- Results first posted
- 2020-09-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery | Day of surgery (Day 1) up to Day 90 | BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (example \[e.g.\] fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 90 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by event adjudication committee (EAC) have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space). |
| Primary | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Within 10 days after Vaccination | Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were categorized as mild (2.5 to 5.0 centimeters \[cm\]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to \[\>=\] 10.5 cm). Pain at the injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling, pain at the injection site represents any grade of these local reactions among mild, moderate or severe. |
| Primary | Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination | Within 10 days after Vaccination | Systemic reactions included fever, fatigue, headache, diarrhea, vomiting, muscle pain and joint pain, were recorded using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (\>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Participants may be represented in more than 1 row. Here "any" for fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain represents any grade of these systemic reactions among mild, moderate or severe. |
| Primary | Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1) | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs. |
| Primary | Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42 | From vaccination until Day 42 after surgery (52-102 days after vaccination) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs. |
| Primary | Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42 | Day of surgery (Day 1) up to Day 42 after surgery | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs. |
| Primary | Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180 | Day 42 up to Day 180 (up to 138 days) | A newly diagnosed chronic medical disorder was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180 | From vaccination up to Day 180 after surgery (190-240 days after vaccination) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1) | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180 | Day of surgery (Day 1) up to Day 180 after surgery | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery | Day of surgery (Day 1) up to Day 90 | Per-protocol (PP) efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Within 10 days after Vaccination | Safety population: all participants who received investigational product in this study. Here, Overall Number of Participants Analyzed, N signifies number of participants analyzed for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination | Within 10 days after Vaccination | Safety population: all participants who received investigational product in this study. Here, Overall Number of Participants Analyzed signifies number of participants analyzed for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1) | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42 | From vaccination until Day 42 after surgery (52-102 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42 | Day of surgery (Day 1) up to Day 42 after surgery | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180 | Day 42 up to Day 180 (up to 138 days) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180 | From vaccination up to Day 180 after surgery (190-240 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1) | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180 | Day of surgery (Day 1) up to Day 180 after surgery | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery | Staphylococcus Aureus 4-antigen (SA4Ag) | 14 | Participants | ||
Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery | Placebo | 14 | Participants | ||
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Staphylococcus Aureus 4-antigen (SA4Ag) | Redness: Any | 9.2 | 95% Confidence Interval 7.9 to 10.7 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Placebo | Redness: Any | 0.9 | 95% Confidence Interval 0.5 to 1.5 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Staphylococcus Aureus 4-antigen (SA4Ag) | Redness: Mild | 5.3 | 95% Confidence Interval 4.2 to 6.4 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Placebo | Redness: Mild | 0.9 | 95% Confidence Interval 0.5 to 1.5 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Staphylococcus Aureus 4-antigen (SA4Ag) | Redness: Moderate | 3.1 | 95% Confidence Interval 2.4 to 4.1 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Placebo | Redness: Moderate | 0.1 | 95% Confidence Interval 0.0 to 0.3 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Staphylococcus Aureus 4-antigen (SA4Ag) | Redness: Severe | 0.8 | 95% Confidence Interval 0.5 to 1.4 | Percentage of participants |
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Placebo | Redness: Severe | 0.0 | 95% Confidence Interval 0.0 to 0.2 | Percentage of participants |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Staphylococcus Aureus 4-antigen (SA4Ag) | 1,726 | |
| Overall Study | STARTED | Placebo | 1,724 | |
| Overall Study | Vaccinated (Safety Population) | Staphylococcus Aureus 4-antigen (SA4Ag) | 1,708 | |
| Overall Study | Vaccinated (Safety Population) | Placebo | 1,709 | |
| Overall Study | COMPLETED | Staphylococcus Aureus 4-antigen (SA4Ag) | 1,599 | |
| Overall Study | COMPLETED | Placebo | 1,594 | |
| Overall Study | NOT COMPLETED | Staphylococcus Aureus 4-antigen (SA4Ag) | 127 | |
| Overall Study | NOT COMPLETED | Placebo | 130 |
Source ClinicalTrials.gov
Adverse events982
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Staphylococcus Aureus 4-antigen (SA4Ag) | 97 | 1,708 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 122 | 1,709 | |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Staphylococcus Aureus 4-antigen (SA4Ag) | 58 | 1,708 | |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Placebo | 42 | 1,709 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Staphylococcus Aureus 4-antigen (SA4Ag) | 18 | 1,708 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 20 | 1,709 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Staphylococcus Aureus 4-antigen (SA4Ag) | 26 | 1,708 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 23 | 1,709 | |
| other | Tachycardia | Cardiac disorders | Staphylococcus Aureus 4-antigen (SA4Ag) | 32 | 1,708 | |
| other | Tachycardia | Cardiac disorders | Placebo | 30 | 1,709 |
1 to 10 of 982Source ClinicalTrials.gov
See all 982 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Staphylococcus Aureus 4-antigen (SA4Ag) | 13 | 1,708 |
| Total, all-cause mortality | Placebo | 10 | 1,709 |
| Total, other adverse events | Staphylococcus Aureus 4-antigen (SA4Ag) | 1,530 | 1,708 |
| Total, other adverse events | Placebo | 1,489 | 1,709 |
| Total, serious adverse events | Staphylococcus Aureus 4-antigen (SA4Ag) | 403 | 1,708 |
| Total, serious adverse events | Placebo | 424 | 1,709 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37125490 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180 | Trial comparisons |
Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery | Trial comparisons |
Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery | Trial comparisons |
| Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42 | Trial comparisons |
| Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42 | Trial comparisons |
Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery | Trial comparisons |
| Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1) | Trial comparisons |
| Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180 | Trial comparisons |
| Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180 | Trial comparisons |
Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Postoperative S. Aureus Blood Stream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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