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

• ClinicalTrials.gov Identifier: NCT02388165
• Recruitment Status: Terminated
• First Posted: March 13, 2015
• Results First Posted: September 2, 2020
• Last Update Posted: January 5, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Staphylococcal Vaccine
• Interventions: Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine; Other: Placebo
• Enrollment: 3450

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description	Participants randomized to SA4Ag received a single dose of 0.5 milliliter (mL) SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Period Title: Overall Study
Started	1726	1724
Vaccinated (Safety Population)	1708	1709
Completed	1599	1594
Not Completed	127	130
Reason Not Completed
Study terminated by sponsor	5	5
Other	11	13
No longer meet eligibility criteria	40	43
Withdrawal of consent	31	32
Lost to Follow-up	19	20
Death	13	10
Adverse Event	3	5
Did not meet entrance criteria	5	2

Baseline Characteristics

Arm/Group Title		Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo	Total
Arm/Group Description		Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Total of all reporting groups
Overall Number of Baseline Participants		1708	1709	3417
Baseline Analysis Population Description		Safety population included all participants who had received investigational product in this study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1708 participants	1709 participants	3417 participants
		62.7 (12.3)	62.6 (12.6)	62.7 (12.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1708 participants	1709 participants	3417 participants
	Female	950 55.6%	940 55.0%	1890 55.3%
	Male	758 44.4%	769 45.0%	1527 44.7%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1708 participants	1709 participants	3417 participants
	Hispanic or Latino	69 4.0%	69 4.0%	138 4.0%
	Not Hispanic or Latino	1634 95.7%	1639 95.9%	3273 95.8%
	Unknown or Not Reported	5 0.3%	1 0.1%	6 0.2%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1708 participants	1709 participants	3417 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	295 17.3%	290 17.0%	585 17.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	90 5.3%	111 6.5%	201 5.9%
	White	1295 75.8%	1283 75.1%	2578 75.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	28 1.6%	25 1.5%	53 1.6%

Outcome Measures

1. Primary Outcome

Title	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
Description	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).
Time Frame	Day of surgery (Day 1) up to Day 90

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1544	1547
Measure Type: Count of Participants; Unit of Measure: Participants
	14 0.9%	14 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Vaccine Efficacy (VE)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -126.30 to 55.81
	Estimation Comments	VE was calculated as 1-(P/[1-P]*100), where P is the number of SA4Ag cases divided by the total number of cases. The confidence interval (CI) was calculated using the Clopper-Pearson method.

2. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Description	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.
Time Frame	Within 10 days after Vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1692	1685
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Any	9.2; (7.9 to 10.7)	0.9; (0.5 to 1.5)
Redness: Mild	5.3; (4.2 to 6.4)	0.9; (0.5 to 1.5)
Redness: Moderate	3.1; (2.4 to 4.1)	0.1; (0.0 to 0.3)
Redness: Severe	0.8; (0.5 to 1.4)	0.0; (0.0 to 0.2)
Swelling: Any	8.0; (6.7 to 9.4)	1.0; (0.6 to 1.6)
Swelling: Mild	4.6; (3.6 to 5.7)	0.7; (0.4 to 1.2)
Swelling: Moderate	2.7; (2.0 to 3.6)	0.3; (0.1 to 0.7)
Swelling: Severe	0.7; (0.4 to 1.2)	0.0; (0.0 to 0.2)
Pain at the injection site: Any	24.1; (22.1 to 26.2)	8.4; (7.1 to 9.9)
Pain at the injection site: Mild	19.2; (17.4 to 21.2)	7.0; (5.8 to 8.3)
Pain at the injection site: Moderate	4.3; (3.4 to 5.4)	1.3; (0.8 to 2.0)
Pain at the injection site: Severe	0.6; (0.3 to 1.1)	0.1; (0.0 to 0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Redness: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	8.3
	Confidence Interval	(2-Sided) 95%; 6.9 to 9.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Redness: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	4.4
	Confidence Interval	(2-Sided) 95%; 3.3 to 5.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Redness: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; 2.3 to 4.0
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Redness: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.5 to 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Swelling: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; 5.7 to 8.4
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Swelling: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; 2.8 to 5.0
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Swelling: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.7 to 3.3
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Swelling: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.4 to 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Pain at the injection site: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	15.7
	Confidence Interval	(2-Sided) 95%; 13.3 to 18.1
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Pain at the injection site: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	12.2
	Confidence Interval	(2-Sided) 95%; 10.0 to 14.5
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Pain at the injection site: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; 1.9 to 4.2
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Pain at the injection site: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.1 to 1.0
	Estimation Comments	[Not Specified]

3. Primary Outcome

Title	Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination
Description	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.
Time Frame	Within 10 days after Vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1692	1685
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: Any	2.0; (1.4 to 2.8)	1.4; (0.9 to 2.0)
Fever: 38.0 degree C to 38.4 degree C	1.3; (0.8 to 2.0)	0.9; (0.5 to 1.5)
Fever: 38.5 degree C to 38.9 degree C	0.5; (0.2 to 0.9)	0.4; (0.2 to 0.9)
Fever: 39.0 degree C to 40.0 degree C	0.2; (0.0 to 0.5)	0.1; (0.0 to 0.3)
Fever: >40.0 degree C	0.1; (0.0 to 0.3)	0.0; (0.0 to 0.2)
Fatigue: Any	43.3; (40.9 to 45.7)	40.4; (38.1 to 42.8)
Fatigue: Mild	14.0; (12.4 to 15.8)	12.6; (11.1 to 14.3)
Fatigue: Moderate	24.9; (22.8 to 27.0)	23.6; (21.6 to 25.7)
Fatigue: Severe	4.4; (3.4 to 5.5)	4.2; (3.3 to 5.2)
Headache: Any	32.4; (30.2 to 34.7)	31.2; (29.0 to 33.5)
Headache: Mild	17.7; (15.9 to 19.6)	18.0; (16.2 to 19.9)
Headache: Moderate	13.5; (11.9 to 15.3)	12.0; (10.5 to 13.6)
Headache: Severe	1.2; (0.8 to 1.9)	1.2; (0.8 to 1.9)
Diarrhea: Any	17.0; (15.2 to 18.8)	16.0; (14.3 to 17.9)
Diarrhea: Mild	13.0; (11.4 to 14.7)	12.2; (10.7 to 13.9)
Diarrhea: Moderate	3.4; (2.6 to 4.4)	2.9; (2.2 to 3.8)
Diarrhea: Severe	0.5; (0.2 to 1.0)	0.9; (0.5 to 1.5)
Vomiting: Any	2.7; (1.9 to 3.5)	3.3; (2.5 to 4.2)
Vomiting: Mild	2.4; (1.7 to 3.2)	2.6; (1.9 to 3.5)
Vomiting: Moderate	0.3; (0.1 to 0.7)	0.7; (0.3 to 1.2)
Vomiting: Severe	0.0; (0.0 to 0.2)	0.0; (0.0 to 0.2)
Muscle pain: Any	27.9; (25.8 to 30.1)	26.2; (24.1 to 28.4)
Muscle pain: Mild	10.1; (8.7 to 11.6)	9.3; (8.0 to 10.8)
Muscle pain: Moderate	15.7; (14.0 to 17.5)	14.6; (12.9 to 16.4)
Muscle pain: Severe	2.1; (1.5 to 2.9)	2.3; (1.7 to 3.2)
Joint pain: Any	27.5; (25.4 to 29.7)	25.8; (23.7 to 28.0)
Joint pain: Mild	9.6; (8.3 to 11.1)	8.0; (6.7 to 9.3)
Joint pain: Moderate	16.1; (14.4 to 17.9)	16.1; (14.4 to 18.0)
Joint pain: Severe	1.8; (1.2 to 2.5)	1.7; (1.2 to 2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fever: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.146
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -0.2 to 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fever: 38.0 degree C to 38.4 degree C
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -0.3 to 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fever: 38.5 degree C to 38.9 degree C
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fever: 39.0 degree C to 40.0 degree C
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fever: >40.0 degree C
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fatigue: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.093
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	2.9
	Confidence Interval	95%; -0.5 to 6.2
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fatigue: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -0.9 to 3.7
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fatigue: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -1.6 to 4.2
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Fatigue: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -1.2 to 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Headache: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.443
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -1.9 to 4.4
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Headache: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -2.9 to 2.3
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Headache: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; -0.7 to 3.8
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Headache: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -0.8 to 0.8
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Diarrhea: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.462
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.6 to 3.4
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Diarrhea: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.5 to 3.0
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Diarrhea: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.5
	Confidence Interval	95%; -0.7 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Diarrhea: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -1.0 to 0.2
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Vomiting: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.300
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	-0.6
	Confidence Interval	95%; -1.8 to 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Vomiting: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -1.3 to 0.8
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Vomiting: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	-0.4
	Confidence Interval	95%; -0.9 to 0.1
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Muscle pain: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.276
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.7
	Confidence Interval	95%; -1.3 to 4.7
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Muscle pain: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -1.2 to 2.8
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Muscle pain: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -1.4 to 3.5
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Muscle pain: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	-0.2
	Confidence Interval	95%; -1.2 to 0.8
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Joint pain: Any
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.273
	Comments	[Not Specified]
	Method	Miettinen and Nurminen
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -1.3 to 4.6
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Joint pain: Mild
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; -0.2 to 3.6
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Joint pain: Moderate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -2.6 to 2.4
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	Joint pain: Severe
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage of participants
	Estimated Value	0.1
	Confidence Interval	95%; -0.9 to 1.0
	Estimation Comments	[Not Specified]

4. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1)
Description	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.
Time Frame	From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received investigational product in this study.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1708	1709
Measure Type: Count of Participants; Unit of Measure: Participants
	213 12.5%	178 10.4%

5. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42
Description	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.
Time Frame	From vaccination until Day 42 after surgery (52-102 days after vaccination)

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received investigational product in this study.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1708	1709
Measure Type: Count of Participants; Unit of Measure: Participants
	1198 70.1%	1213 71.0%

6. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42
Description	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.
Time Frame	Day of surgery (Day 1) up to Day 42 after surgery

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received investigational product in this study.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1708	1709
Measure Type: Count of Participants; Unit of Measure: Participants
	1136 66.5%	1167 68.3%

7. Primary Outcome

Title	Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180
Description	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.
Time Frame	Day 42 up to Day 180 (up to 138 days)

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received investigational product in this study.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1708	1709
Measure Type: Count of Participants; Unit of Measure: Participants
	29 1.7%	41 2.4%

8. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180
Description	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.
Time Frame	From vaccination up to Day 180 after surgery (190-240 days after vaccination)

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received investigational product in this study.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1708	1709
Measure Type: Count of Participants; Unit of Measure: Participants
	403 23.6%	424 24.8%

9. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1)
Description	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.
Time Frame	From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received investigational product in this study.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1708	1709
Measure Type: Count of Participants; Unit of Measure: Participants
	27 1.6%	26 1.5%

10. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180
Description	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.
Time Frame	Day of surgery (Day 1) up to Day 180 after surgery

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received investigational product in this study.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1708	1709
Measure Type: Count of Participants; Unit of Measure: Participants
	384 22.5%	401 23.5%

11. Secondary Outcome

Title	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
Description	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 (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 180 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by EAC have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space).
Time Frame	Day of surgery (Day 1) up to Day 180 after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1544	1547
Measure Type: Count of Participants; Unit of Measure: Participants
	14 0.9%	14 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	VE
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -126.30 to 55.81
	Estimation Comments	VE was calculated as 1-(P/[1-P]*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.

12. Secondary Outcome

Title	Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery
Description	SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (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 SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 90 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported.
Time Frame	Day of surgery (Day 1) up to Day 90 after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1544	1547
Measure Type: Count of Participants; Unit of Measure: Participants
	24 1.6%	22 1.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	VE
	Estimated Value	-9.09
	Confidence Interval	(2-Sided) 95%; -104.06 to 41.41
	Estimation Comments	VE was calculated as 1-(P/[1-P]*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.

13. Secondary Outcome

Title	Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery
Description	SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (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 SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 180 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported.
Time Frame	Day of surgery (Day 1) up to Day 180 after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description:	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Number of Participants Analyzed	1544	1547
Measure Type: Count of Participants; Unit of Measure: Participants
	25 1.6%	23 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Staphylococcus Aureus 4-antigen (SA4Ag), Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	VE
	Estimated Value	-8.70
	Confidence Interval	(2-Sided) 95%; -100.42 to 40.80
	Estimation Comments	VE was calculated as 1-(P/[1-P]*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.

Adverse Events

Time Frame	SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment).
Adverse Event Reporting Description	Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Arm/Group Title	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
Arm/Group Description	Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
All-Cause Mortality
	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	13/1708 (0.76%)	10/1709 (0.59%)
Serious Adverse Events
	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	403/1708 (23.59%)	424/1709 (24.81%)
Blood and lymphatic system disorders
Anaemia * 1	4/1708 (0.23%)	4/1709 (0.23%)
Blood loss anaemia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Coagulopathy * 1	0/1708 (0.00%)	1/1709 (0.06%)
Disseminated intravascular coagulation * 1	1/1708 (0.06%)	0/1709 (0.00%)
Heparin-induced thrombocytopenia * 1	1/1708 (0.06%)	1/1709 (0.06%)
Iron deficiency anaemia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Leukocytosis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Normocytic anaemia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Pancytopenia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Platelet disorder * 1	0/1708 (0.00%)	1/1709 (0.06%)
Thrombocytopenia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cardiac disorders
Acute coronary syndrome * 1	0/1708 (0.00%)	1/1709 (0.06%)
Acute myocardial infarction * 1	3/1708 (0.18%)	4/1709 (0.23%)
Acute right ventricular failure * 1	1/1708 (0.06%)	0/1709 (0.00%)
Angina pectoris * 1	0/1708 (0.00%)	2/1709 (0.12%)
Angina unstable * 1	1/1708 (0.06%)	0/1709 (0.00%)
Arteriospasm coronary * 1	1/1708 (0.06%)	0/1709 (0.00%)
Atrial fibrillation * 1	12/1708 (0.70%)	10/1709 (0.59%)
Atrial flutter * 1	1/1708 (0.06%)	1/1709 (0.06%)
Bradycardia * 1	2/1708 (0.12%)	2/1709 (0.12%)
Cardiac arrest * 1	0/1708 (0.00%)	2/1709 (0.12%)
Cardiac failure * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cardiac failure acute * 1	0/1708 (0.00%)	1/1709 (0.06%)
Cardiac failure chronic * 1	0/1708 (0.00%)	1/1709 (0.06%)
Cardiac failure congestive * 1	1/1708 (0.06%)	4/1709 (0.23%)
Cardiac ventricular thrombosis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Cardio-respiratory arrest * 1	0/1708 (0.00%)	1/1709 (0.06%)
Cardiogenic shock * 1	2/1708 (0.12%)	0/1709 (0.00%)
Coronary artery disease * 1	1/1708 (0.06%)	4/1709 (0.23%)
Coronary artery occlusion * 1	0/1708 (0.00%)	1/1709 (0.06%)
Coronary artery stenosis * 1	0/1708 (0.00%)	2/1709 (0.12%)
Left ventricular dysfunction * 1	0/1708 (0.00%)	1/1709 (0.06%)
Myocardial infarction * 1	4/1708 (0.23%)	2/1709 (0.12%)
Sinus node dysfunction * 1	1/1708 (0.06%)	0/1709 (0.00%)
Sinus tachycardia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Supraventricular tachycardia * 1	1/1708 (0.06%)	1/1709 (0.06%)
Tachycardia * 1	2/1708 (0.12%)	3/1709 (0.18%)
Ventricular tachycardia * 1	0/1708 (0.00%)	2/1709 (0.12%)
Congenital, familial and genetic disorders
Spinal muscular atrophy * 1	0/1708 (0.00%)	1/1709 (0.06%)
Ear and labyrinth disorders
Vertigo positional * 1	0/1708 (0.00%)	1/1709 (0.06%)
Endocrine disorders
Inappropriate antidiuretic hormone secretion * 1	1/1708 (0.06%)	0/1709 (0.00%)
Eye disorders
Blindness unilateral * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cataract * 1	0/1708 (0.00%)	2/1709 (0.12%)
Retinal detachment * 1	1/1708 (0.06%)	0/1709 (0.00%)
Gastrointestinal disorders
Abdominal pain * 1	2/1708 (0.12%)	1/1709 (0.06%)
Abdominal pain upper * 1	1/1708 (0.06%)	1/1709 (0.06%)
Anal incontinence * 1	0/1708 (0.00%)	1/1709 (0.06%)
Anorectal disorder * 1	1/1708 (0.06%)	0/1709 (0.00%)
Colitis * 1	2/1708 (0.12%)	2/1709 (0.12%)
Colitis ischaemic * 1	0/1708 (0.00%)	1/1709 (0.06%)
Constipation * 1	3/1708 (0.18%)	4/1709 (0.23%)
Diarrhoea * 1	1/1708 (0.06%)	1/1709 (0.06%)
Diverticulum * 1	0/1708 (0.00%)	1/1709 (0.06%)
Duodenal ulcer * 1	2/1708 (0.12%)	0/1709 (0.00%)
Duodenal ulcer haemorrhage * 1	0/1708 (0.00%)	1/1709 (0.06%)
Dysphagia * 1	1/1708 (0.06%)	1/1709 (0.06%)
Gastric haemorrhage * 1	0/1708 (0.00%)	1/1709 (0.06%)
Gastritis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Gastrointestinal haemorrhage * 1	3/1708 (0.18%)	1/1709 (0.06%)
Gastrointestinal ulcer * 1	1/1708 (0.06%)	0/1709 (0.00%)
Gastrooesophageal reflux disease * 1	0/1708 (0.00%)	1/1709 (0.06%)
Ileus * 1	2/1708 (0.12%)	5/1709 (0.29%)
Impaired gastric emptying * 1	0/1708 (0.00%)	1/1709 (0.06%)
Inguinal hernia * 1	3/1708 (0.18%)	1/1709 (0.06%)
Intestinal obstruction * 1	2/1708 (0.12%)	0/1709 (0.00%)
Large intestine perforation * 1	1/1708 (0.06%)	0/1709 (0.00%)
Large intestine polyp * 1	0/1708 (0.00%)	2/1709 (0.12%)
Lower gastrointestinal haemorrhage * 1	1/1708 (0.06%)	0/1709 (0.00%)
Melaena * 1	1/1708 (0.06%)	0/1709 (0.00%)
Nausea * 1	1/1708 (0.06%)	1/1709 (0.06%)
Obstruction gastric * 1	1/1708 (0.06%)	1/1709 (0.06%)
Pancreatitis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Pancreatitis acute * 1	1/1708 (0.06%)	3/1709 (0.18%)
Pneumoperitoneum * 1	1/1708 (0.06%)	0/1709 (0.00%)
Proctitis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Rectal haemorrhage * 1	0/1708 (0.00%)	2/1709 (0.12%)
Rectal prolapse * 1	0/1708 (0.00%)	1/1709 (0.06%)
Retroperitoneal haematoma * 1	1/1708 (0.06%)	0/1709 (0.00%)
Small intestinal obstruction * 1	4/1708 (0.23%)	1/1709 (0.06%)
Subileus * 1	0/1708 (0.00%)	1/1709 (0.06%)
Vomiting * 1	1/1708 (0.06%)	0/1709 (0.00%)
Abdominal distension * 1	0/1708 (0.00%)	1/1709 (0.06%)
General disorders
Asthenia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Calcinosis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Chest pain * 1	3/1708 (0.18%)	5/1709 (0.29%)
Complication associated with device * 1	0/1708 (0.00%)	2/1709 (0.12%)
Complication of device insertion * 1	0/1708 (0.00%)	1/1709 (0.06%)
Dysplasia * 1	0/1708 (0.00%)	2/1709 (0.12%)
Fatigue * 1	0/1708 (0.00%)	1/1709 (0.06%)
Fibrosis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Gait disturbance * 1	1/1708 (0.06%)	0/1709 (0.00%)
Hernia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Impaired healing * 1	2/1708 (0.12%)	1/1709 (0.06%)
Medical device site reaction * 1	1/1708 (0.06%)	0/1709 (0.00%)
Multiple organ dysfunction syndrome * 1	4/1708 (0.23%)	3/1709 (0.18%)
Pain * 1	3/1708 (0.18%)	3/1709 (0.18%)
Peripheral swelling * 1	2/1708 (0.12%)	1/1709 (0.06%)
Pyrexia * 1	6/1708 (0.35%)	7/1709 (0.41%)
Surgical failure * 1	0/1708 (0.00%)	1/1709 (0.06%)
Hepatobiliary disorders
Bile duct stone * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cholecystitis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Cholecystitis acute * 1	4/1708 (0.23%)	4/1709 (0.23%)
Cholelithiasis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Immune system disorders
Anaphylactic reaction * 1	0/1708 (0.00%)	1/1709 (0.06%)
Anaphylactic shock * 1	0/1708 (0.00%)	1/1709 (0.06%)
Drug hypersensitivity * 1	2/1708 (0.12%)	2/1709 (0.12%)
Infections and infestations
Abscess jaw * 1	1/1708 (0.06%)	0/1709 (0.00%)
Abscess limb * 1	1/1708 (0.06%)	0/1709 (0.00%)
Atypical pneumonia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Bacteraemia * 1	0/1708 (0.00%)	3/1709 (0.18%)
Bacterial disease carrier * 1	1/1708 (0.06%)	0/1709 (0.00%)
Bronchitis * 1	3/1708 (0.18%)	2/1709 (0.12%)
Cellulitis * 1	5/1708 (0.29%)	4/1709 (0.23%)
Clostridium colitis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Clostridium difficile colitis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Clostridium difficile infection * 1	1/1708 (0.06%)	1/1709 (0.06%)
Cystitis * 1	1/1708 (0.06%)	1/1709 (0.06%)
Device related infection * 1	1/1708 (0.06%)	2/1709 (0.12%)
Diverticulitis * 1	2/1708 (0.12%)	1/1709 (0.06%)
Encephalitis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Enterobacter bacteraemia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Escherichia bacteraemia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Escherichia urinary tract infection * 1	0/1708 (0.00%)	1/1709 (0.06%)
Extradural abscess * 1	0/1708 (0.00%)	1/1709 (0.06%)
Fournier's gangrene * 1	0/1708 (0.00%)	1/1709 (0.06%)
Gastroenteritis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Herpes zoster * 1	0/1708 (0.00%)	1/1709 (0.06%)
Incision site abscess * 1	0/1708 (0.00%)	1/1709 (0.06%)
Infected skin ulcer * 1	0/1708 (0.00%)	1/1709 (0.06%)
Influenza * 1	2/1708 (0.12%)	1/1709 (0.06%)
Intervertebral discitis * 1	1/1708 (0.06%)	2/1709 (0.12%)
Lice infestation * 1	1/1708 (0.06%)	0/1709 (0.00%)
Lymphangitis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Medical device site joint infection * 1	0/1708 (0.00%)	1/1709 (0.06%)
Meningitis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Osteomyelitis * 1	2/1708 (0.12%)	2/1709 (0.12%)
Osteomyelitis chronic * 1	1/1708 (0.06%)	0/1709 (0.00%)
Perirectal abscess * 1	0/1708 (0.00%)	1/1709 (0.06%)
Pneumonia * 1	19/1708 (1.11%)	12/1709 (0.70%)
Pneumonia bacterial * 1	1/1708 (0.06%)	0/1709 (0.00%)
Post procedural infection * 1	1/1708 (0.06%)	1/1709 (0.06%)
Postoperative wound infection * 1	27/1708 (1.58%)	32/1709 (1.87%)
Pyelonephritis * 1	2/1708 (0.12%)	2/1709 (0.12%)
Pyelonephritis acute * 1	1/1708 (0.06%)	0/1709 (0.00%)
Sepsis * 1	11/1708 (0.64%)	10/1709 (0.59%)
Septic shock * 1	1/1708 (0.06%)	1/1709 (0.06%)
Skin infection * 1	0/1708 (0.00%)	3/1709 (0.18%)
Staphylococcal infection * 1	1/1708 (0.06%)	1/1709 (0.06%)
Upper respiratory tract infection * 1	1/1708 (0.06%)	0/1709 (0.00%)
Urinary tract infection * 1	6/1708 (0.35%)	7/1709 (0.41%)
Urosepsis * 1	2/1708 (0.12%)	1/1709 (0.06%)
Viral infection * 1	1/1708 (0.06%)	0/1709 (0.00%)
Wound infection * 1	5/1708 (0.29%)	5/1709 (0.29%)
Wound infection bacterial * 1	1/1708 (0.06%)	3/1709 (0.18%)
Wound infection fungal * 1	0/1708 (0.00%)	1/1709 (0.06%)
Wound infection staphylococcal * 1	0/1708 (0.00%)	3/1709 (0.18%)
Uncoded System Organ Class * 1	0/1708 (0.00%)	1/1709 (0.06%)
Meningoencephalitis septic shock * 1	0/1708 (0.00%)	1/1709 (0.06%)
Injury, poisoning and procedural complications
Adjacent segment degeneration * 1	1/1708 (0.06%)	1/1709 (0.06%)
Anaemia postoperative * 1	8/1708 (0.47%)	3/1709 (0.18%)
Ankle fracture * 1	0/1708 (0.00%)	2/1709 (0.12%)
Aortic injury * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cardiac function disturbance postoperative * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cervical vertebral fracture * 1	2/1708 (0.12%)	1/1709 (0.06%)
Concussion * 1	2/1708 (0.12%)	0/1709 (0.00%)
Contusion * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cystitis radiation * 1	1/1708 (0.06%)	0/1709 (0.00%)
Device deployment issue * 1	1/1708 (0.06%)	1/1709 (0.06%)
Device dispensing error * 1	0/1708 (0.00%)	1/1709 (0.06%)
Dural tear * 1	9/1708 (0.53%)	9/1709 (0.53%)
Endotracheal intubation complication * 1	0/1708 (0.00%)	1/1709 (0.06%)
Exposure to communicable disease * 1	0/1708 (0.00%)	1/1709 (0.06%)
Extradural haematoma * 1	4/1708 (0.23%)	1/1709 (0.06%)
Facial bones fracture * 1	0/1708 (0.00%)	1/1709 (0.06%)
Fall * 1	9/1708 (0.53%)	3/1709 (0.18%)
Femoral neck fracture * 1	1/1708 (0.06%)	2/1709 (0.12%)
Femur fracture * 1	1/1708 (0.06%)	2/1709 (0.12%)
Flatback syndrome * 1	0/1708 (0.00%)	1/1709 (0.06%)
Foreign body * 1	0/1708 (0.00%)	1/1709 (0.06%)
Fracture * 1	1/1708 (0.06%)	0/1709 (0.00%)
Fractured sacrum * 1	1/1708 (0.06%)	3/1709 (0.18%)
Graft complication * 1	0/1708 (0.00%)	1/1709 (0.06%)
Heart injury * 1	1/1708 (0.06%)	0/1709 (0.00%)
Hip fracture * 1	0/1708 (0.00%)	2/1709 (0.12%)
Humerus fracture * 1	1/1708 (0.06%)	1/1709 (0.06%)
Incision site haematoma * 1	0/1708 (0.00%)	1/1709 (0.06%)
Incomplete spinal fusion * 1	1/1708 (0.06%)	0/1709 (0.00%)
Joint dislocation * 1	1/1708 (0.06%)	1/1709 (0.06%)
Lumbar vertebral fracture * 1	6/1708 (0.35%)	5/1709 (0.29%)
Multiple fractures * 1	1/1708 (0.06%)	0/1709 (0.00%)
Multiple injuries * 1	1/1708 (0.06%)	0/1709 (0.00%)
Muscle strain * 1	1/1708 (0.06%)	0/1709 (0.00%)
Overdose * 1	0/1708 (0.00%)	3/1709 (0.18%)
Periprosthetic fracture * 1	0/1708 (0.00%)	1/1709 (0.06%)
Post laminectomy syndrome * 1	1/1708 (0.06%)	0/1709 (0.00%)
Post procedural complication * 1	0/1708 (0.00%)	1/1709 (0.06%)
Post procedural constipation * 1	1/1708 (0.06%)	0/1709 (0.00%)
Post procedural discharge * 1	3/1708 (0.18%)	2/1709 (0.12%)
Post procedural fever * 1	1/1708 (0.06%)	0/1709 (0.00%)
Post procedural haematoma * 1	3/1708 (0.18%)	7/1709 (0.41%)
Post procedural haemorrhage * 1	1/1708 (0.06%)	0/1709 (0.00%)
Postoperative delirium * 1	1/1708 (0.06%)	3/1709 (0.18%)
Postoperative ileus * 1	3/1708 (0.18%)	7/1709 (0.41%)
Procedural complication * 1	1/1708 (0.06%)	0/1709 (0.00%)
Procedural haemorrhage * 1	4/1708 (0.23%)	3/1709 (0.18%)
Procedural hypotension * 1	1/1708 (0.06%)	0/1709 (0.00%)
Procedural pain * 1	7/1708 (0.41%)	9/1709 (0.53%)
Pseudomeningocele * 1	0/1708 (0.00%)	1/1709 (0.06%)
Road traffic accident * 1	0/1708 (0.00%)	2/1709 (0.12%)
Seroma * 1	6/1708 (0.35%)	4/1709 (0.23%)
Spinal column injury * 1	1/1708 (0.06%)	0/1709 (0.00%)
Spinal compression fracture * 1	6/1708 (0.35%)	2/1709 (0.12%)
Spinal cord injury cauda equina * 1	0/1708 (0.00%)	1/1709 (0.06%)
Spinal fracture * 1	1/1708 (0.06%)	2/1709 (0.12%)
Subdural haematoma * 1	2/1708 (0.12%)	2/1709 (0.12%)
Subdural haemorrhage * 1	1/1708 (0.06%)	0/1709 (0.00%)
Suture rupture * 1	1/1708 (0.06%)	0/1709 (0.00%)
Thoracic vertebral fracture * 1	4/1708 (0.23%)	4/1709 (0.23%)
Tibia fracture * 1	0/1708 (0.00%)	1/1709 (0.06%)
Toxicity to various agents * 1	1/1708 (0.06%)	1/1709 (0.06%)
Urethral injury * 1	1/1708 (0.06%)	0/1709 (0.00%)
Urinary retention postoperative * 1	0/1708 (0.00%)	1/1709 (0.06%)
Vascular injury * 1	1/1708 (0.06%)	0/1709 (0.00%)
Venous injury * 1	0/1708 (0.00%)	1/1709 (0.06%)
Wound dehiscence * 1	5/1708 (0.29%)	4/1709 (0.23%)
Wound secretion * 1	1/1708 (0.06%)	2/1709 (0.12%)
Lower limb fracture * 1	1/1708 (0.06%)	0/1709 (0.00%)
Investigations
Blood glucose increased * 1	1/1708 (0.06%)	0/1709 (0.00%)
Electrocardiogram abnormal * 1	1/1708 (0.06%)	0/1709 (0.00%)
Haemoglobin decreased * 1	0/1708 (0.00%)	1/1709 (0.06%)
Hepatic enzyme increased * 1	0/1708 (0.00%)	2/1709 (0.12%)
Oxygen saturation decreased * 1	1/1708 (0.06%)	0/1709 (0.00%)
Troponin increased * 1	1/1708 (0.06%)	0/1709 (0.00%)
Metabolism and nutrition disorders
Dehydration * 1	0/1708 (0.00%)	3/1709 (0.18%)
Diabetic ketoacidosis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Failure to thrive * 1	1/1708 (0.06%)	2/1709 (0.12%)
Fluid overload * 1	1/1708 (0.06%)	0/1709 (0.00%)
Gout * 1	0/1708 (0.00%)	1/1709 (0.06%)
Hyperkalaemia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Hypoglycaemia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Hyponatraemia * 1	3/1708 (0.18%)	1/1709 (0.06%)
Hypovolaemia * 1	3/1708 (0.18%)	3/1709 (0.18%)
Metabolic acidosis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/1708 (0.00%)	2/1709 (0.12%)
Arthritis * 1	1/1708 (0.06%)	2/1709 (0.12%)
Arthropathy * 1	0/1708 (0.00%)	1/1709 (0.06%)
Back pain * 1	8/1708 (0.47%)	7/1709 (0.41%)
Bone disorder * 1	0/1708 (0.00%)	1/1709 (0.06%)
Bursitis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Compartment syndrome * 1	1/1708 (0.06%)	0/1709 (0.00%)
Foot deformity * 1	1/1708 (0.06%)	1/1709 (0.06%)
Fracture nonunion * 1	0/1708 (0.00%)	1/1709 (0.06%)
Intervertebral disc degeneration * 1	0/1708 (0.00%)	2/1709 (0.12%)
Intervertebral disc disorder * 1	2/1708 (0.12%)	1/1709 (0.06%)
Intervertebral disc protrusion * 1	2/1708 (0.12%)	3/1709 (0.18%)
Joint instability * 1	0/1708 (0.00%)	1/1709 (0.06%)
Kyphosis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Mobility decreased * 1	1/1708 (0.06%)	0/1709 (0.00%)
Muscle spasms * 1	1/1708 (0.06%)	2/1709 (0.12%)
Muscular weakness * 1	4/1708 (0.23%)	3/1709 (0.18%)
Musculoskeletal chest pain * 1	1/1708 (0.06%)	1/1709 (0.06%)
Musculoskeletal disorder * 1	0/1708 (0.00%)	1/1709 (0.06%)
Myalgia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Myopathy * 1	1/1708 (0.06%)	0/1709 (0.00%)
Neck pain * 1	0/1708 (0.00%)	1/1709 (0.06%)
Osteoarthritis * 1	3/1708 (0.18%)	12/1709 (0.70%)
Pain in extremity * 1	7/1708 (0.41%)	1/1709 (0.06%)
Polymyalgia rheumatica * 1	0/1708 (0.00%)	1/1709 (0.06%)
Polymyositis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Rhabdomyolysis * 1	1/1708 (0.06%)	1/1709 (0.06%)
Rheumatoid arthritis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Rotator cuff syndrome * 1	0/1708 (0.00%)	3/1709 (0.18%)
Scoliosis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Spinal deformity * 1	2/1708 (0.12%)	1/1709 (0.06%)
Spinal disorder * 1	0/1708 (0.00%)	1/1709 (0.06%)
Spinal instability * 1	5/1708 (0.29%)	3/1709 (0.18%)
Spinal ligament ossification * 1	2/1708 (0.12%)	0/1709 (0.00%)
Spinal osteoarthritis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Spinal segmental dysfunction * 1	0/1708 (0.00%)	1/1709 (0.06%)
Spinal stenosis * 1	4/1708 (0.23%)	1/1709 (0.06%)
Spondylolisthesis * 1	3/1708 (0.18%)	2/1709 (0.12%)
Vertebral foraminal stenosis * 1	2/1708 (0.12%)	1/1709 (0.06%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon * 1	1/1708 (0.06%)	1/1709 (0.06%)
Basal cell carcinoma * 1	1/1708 (0.06%)	0/1709 (0.00%)
Bone neoplasm * 1	1/1708 (0.06%)	0/1709 (0.00%)
Breast cancer * 1	1/1708 (0.06%)	1/1709 (0.06%)
Clear cell renal cell carcinoma * 1	0/1708 (0.00%)	1/1709 (0.06%)
Gastric neoplasm * 1	0/1708 (0.00%)	1/1709 (0.06%)
Glioblastoma * 1	1/1708 (0.06%)	0/1709 (0.00%)
Invasive breast carcinoma * 1	0/1708 (0.00%)	1/1709 (0.06%)
Lung neoplasm malignant * 1	1/1708 (0.06%)	1/1709 (0.06%)
Malignant neoplasm of ampulla of vater * 1	1/1708 (0.06%)	0/1709 (0.00%)
Mediastinum neoplasm * 1	1/1708 (0.06%)	0/1709 (0.00%)
Metastases to liver * 1	1/1708 (0.06%)	0/1709 (0.00%)
Myeloid leukaemia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Non-Hodgkin's lymphoma * 1	1/1708 (0.06%)	0/1709 (0.00%)
Ovarian cancer * 1	1/1708 (0.06%)	0/1709 (0.00%)
Pancreatic carcinoma metastatic * 1	1/1708 (0.06%)	0/1709 (0.00%)
Prostate cancer * 1	2/1708 (0.12%)	1/1709 (0.06%)
Renal cancer * 1	1/1708 (0.06%)	0/1709 (0.00%)
Spinal meningioma benign * 1	0/1708 (0.00%)	1/1709 (0.06%)
Squamous cell carcinoma * 1	0/1708 (0.00%)	1/1709 (0.06%)
Nervous system disorders
Carpal tunnel syndrome * 1	0/1708 (0.00%)	1/1709 (0.06%)
Cauda equina syndrome * 1	1/1708 (0.06%)	0/1709 (0.00%)
Cerebral haemorrhage * 1	0/1708 (0.00%)	1/1709 (0.06%)
Cerebral infarction * 1	1/1708 (0.06%)	1/1709 (0.06%)
Cerebrospinal fistula * 1	0/1708 (0.00%)	2/1709 (0.12%)
Cerebrospinal fluid leakage * 1	5/1708 (0.29%)	5/1709 (0.29%)
Cerebrovascular accident * 1	2/1708 (0.12%)	2/1709 (0.12%)
Cervical radiculopathy * 1	2/1708 (0.12%)	0/1709 (0.00%)
Cervical spinal cord paralysis * 1	1/1708 (0.06%)	2/1709 (0.12%)
Decreased vibratory sense * 1	0/1708 (0.00%)	1/1709 (0.06%)
Dizziness * 1	1/1708 (0.06%)	1/1709 (0.06%)
Dysarthria * 1	1/1708 (0.06%)	0/1709 (0.00%)
Encephalopathy * 1	4/1708 (0.23%)	5/1709 (0.29%)
Facial paralysis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Generalised tonic-clonic seizure * 1	1/1708 (0.06%)	0/1709 (0.00%)
Headache * 1	1/1708 (0.06%)	2/1709 (0.12%)
Hemiparesis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Hepatic encephalopathy * 1	1/1708 (0.06%)	0/1709 (0.00%)
IIIrd nerve paresis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Ischaemic stroke * 1	1/1708 (0.06%)	1/1709 (0.06%)
Loss of consciousness * 1	0/1708 (0.00%)	1/1709 (0.06%)
Lumbar radiculopathy * 1	0/1708 (0.00%)	2/1709 (0.12%)
Metabolic encephalopathy * 1	1/1708 (0.06%)	2/1709 (0.12%)
Miller Fisher syndrome * 1	1/1708 (0.06%)	0/1709 (0.00%)
Monoparesis * 1	1/1708 (0.06%)	1/1709 (0.06%)
Monoplegia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Myelopathy * 1	2/1708 (0.12%)	1/1709 (0.06%)
Neuropathy peripheral * 1	0/1708 (0.00%)	1/1709 (0.06%)
Normal pressure hydrocephalus * 1	1/1708 (0.06%)	0/1709 (0.00%)
Paraesthesia * 1	0/1708 (0.00%)	2/1709 (0.12%)
Paralysis * 1	3/1708 (0.18%)	0/1709 (0.00%)
Paraparesis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Paraplegia * 1	2/1708 (0.12%)	1/1709 (0.06%)
Parkinson's disease * 1	0/1708 (0.00%)	1/1709 (0.06%)
Polyneuropathy * 1	1/1708 (0.06%)	0/1709 (0.00%)
Presyncope * 1	2/1708 (0.12%)	1/1709 (0.06%)
Radiculopathy * 1	2/1708 (0.12%)	2/1709 (0.12%)
Sciatica * 1	2/1708 (0.12%)	4/1709 (0.23%)
Sedation * 1	1/1708 (0.06%)	0/1709 (0.00%)
Seizure * 1	3/1708 (0.18%)	1/1709 (0.06%)
Spinal cord compression * 1	1/1708 (0.06%)	0/1709 (0.00%)
Spinal cord disorder * 1	0/1708 (0.00%)	1/1709 (0.06%)
Spinal epidural haematoma * 1	2/1708 (0.12%)	1/1709 (0.06%)
Syncope * 1	2/1708 (0.12%)	5/1709 (0.29%)
Thalamus haemorrhage * 1	1/1708 (0.06%)	0/1709 (0.00%)
Thrombotic cerebral infarction * 1	0/1708 (0.00%)	1/1709 (0.06%)
Transient ischaemic attack * 1	4/1708 (0.23%)	4/1709 (0.23%)
Trigeminal neuralgia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Visual field defect * 1	1/1708 (0.06%)	0/1709 (0.00%)
Vocal cord paralysis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Product Issues
Device breakage * 1	2/1708 (0.12%)	2/1709 (0.12%)
Device dislocation * 1	11/1708 (0.64%)	6/1709 (0.35%)
Device failure * 1	3/1708 (0.18%)	6/1709 (0.35%)
Device fastener issue * 1	3/1708 (0.18%)	1/1709 (0.06%)
Device loosening * 1	3/1708 (0.18%)	2/1709 (0.12%)
Implant subsidence * 1	0/1708 (0.00%)	1/1709 (0.06%)
Psychiatric disorders
Alcohol withdrawal syndrome * 1	1/1708 (0.06%)	0/1709 (0.00%)
Anxiety * 1	0/1708 (0.00%)	1/1709 (0.06%)
Confusional state * 1	2/1708 (0.12%)	2/1709 (0.12%)
Delirium * 1	3/1708 (0.18%)	4/1709 (0.23%)
Delirium tremens * 1	1/1708 (0.06%)	0/1709 (0.00%)
Mental disorder * 1	0/1708 (0.00%)	1/1709 (0.06%)
Mental status changes * 1	4/1708 (0.23%)	7/1709 (0.41%)
Suicidal ideation * 1	1/1708 (0.06%)	1/1709 (0.06%)
Renal and urinary disorders
Acute kidney injury * 1	6/1708 (0.35%)	8/1709 (0.47%)
Bladder disorder * 1	1/1708 (0.06%)	0/1709 (0.00%)
Bladder neck obstruction * 1	0/1708 (0.00%)	1/1709 (0.06%)
Chronic kidney disease * 1	0/1708 (0.00%)	1/1709 (0.06%)
Dysuria * 1	1/1708 (0.06%)	0/1709 (0.00%)
Haematuria * 1	0/1708 (0.00%)	1/1709 (0.06%)
Nephrolithiasis * 1	2/1708 (0.12%)	1/1709 (0.06%)
Nephropathy * 1	0/1708 (0.00%)	1/1709 (0.06%)
Neurogenic bladder * 1	1/1708 (0.06%)	0/1709 (0.00%)
Renal failure * 1	0/1708 (0.00%)	2/1709 (0.12%)
Renal injury * 1	0/1708 (0.00%)	1/1709 (0.06%)
Ureterolithiasis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Urethral stenosis * 1	0/1708 (0.00%)	2/1709 (0.12%)
Urinary incontinence * 1	0/1708 (0.00%)	1/1709 (0.06%)
Urinary retention * 1	4/1708 (0.23%)	3/1709 (0.18%)
Reproductive system and breast disorders
Benign prostatic hyperplasia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Erectile dysfunction * 1	0/1708 (0.00%)	1/1709 (0.06%)
Prostatic haemorrhage * 1	0/1708 (0.00%)	1/1709 (0.06%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome * 1	2/1708 (0.12%)	0/1709 (0.00%)
Acute respiratory failure * 1	7/1708 (0.41%)	4/1709 (0.23%)
Aspiration * 1	1/1708 (0.06%)	0/1709 (0.00%)
Asthma * 1	1/1708 (0.06%)	1/1709 (0.06%)
Atelectasis * 1	2/1708 (0.12%)	1/1709 (0.06%)
Chronic obstructive pulmonary disease * 1	2/1708 (0.12%)	0/1709 (0.00%)
Dyspnoea * 1	2/1708 (0.12%)	2/1709 (0.12%)
Eosinophilic pneumonia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Haemothorax * 1	0/1708 (0.00%)	1/1709 (0.06%)
Hypoxia * 1	3/1708 (0.18%)	4/1709 (0.23%)
Interstitial lung disease * 1	0/1708 (0.00%)	1/1709 (0.06%)
Pharyngeal oedema * 1	0/1708 (0.00%)	1/1709 (0.06%)
Pharyngeal ulceration * 1	1/1708 (0.06%)	0/1709 (0.00%)
Pleural effusion * 1	0/1708 (0.00%)	1/1709 (0.06%)
Pneumonia aspiration * 1	2/1708 (0.12%)	2/1709 (0.12%)
Pneumothorax * 1	1/1708 (0.06%)	0/1709 (0.00%)
Pulmonary embolism * 1	22/1708 (1.29%)	17/1709 (0.99%)
Pulmonary hypertension * 1	1/1708 (0.06%)	1/1709 (0.06%)
Pulmonary infarction * 1	1/1708 (0.06%)	1/1709 (0.06%)
Pulmonary oedema * 1	3/1708 (0.18%)	2/1709 (0.12%)
Pulmonary thrombosis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Respiratory arrest * 1	1/1708 (0.06%)	0/1709 (0.00%)
Respiratory depression * 1	1/1708 (0.06%)	0/1709 (0.00%)
Respiratory distress * 1	0/1708 (0.00%)	1/1709 (0.06%)
Respiratory failure * 1	3/1708 (0.18%)	7/1709 (0.41%)
Respiratory tract oedema * 1	0/1708 (0.00%)	1/1709 (0.06%)
Sleep apnoea syndrome * 1	1/1708 (0.06%)	0/1709 (0.00%)
Skin and subcutaneous tissue disorders
Decubitus ulcer * 1	1/1708 (0.06%)	0/1709 (0.00%)
Skin ulcer * 1	2/1708 (0.12%)	0/1709 (0.00%)
Swelling face * 1	0/1708 (0.00%)	2/1709 (0.12%)
Surgical and medical procedures
Arthrodesis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Muscle flap operation * 1	1/1708 (0.06%)	0/1709 (0.00%)
Spinal fusion surgery * 1	1/1708 (0.06%)	0/1709 (0.00%)
Vascular disorders
Deep vein thrombosis * 1	21/1708 (1.23%)	19/1709 (1.11%)
Haematoma * 1	2/1708 (0.12%)	3/1709 (0.18%)
Haemodynamic instability * 1	1/1708 (0.06%)	0/1709 (0.00%)
Haemorrhage * 1	2/1708 (0.12%)	1/1709 (0.06%)
Hypertension * 1	0/1708 (0.00%)	1/1709 (0.06%)
Hypotension * 1	13/1708 (0.76%)	10/1709 (0.59%)
Hypovolaemic shock * 1	1/1708 (0.06%)	3/1709 (0.18%)
Iliac artery occlusion * 1	0/1708 (0.00%)	1/1709 (0.06%)
Intermittent claudication * 1	0/1708 (0.00%)	1/1709 (0.06%)
Ischaemia * 1	0/1708 (0.00%)	1/1709 (0.06%)
Labile blood pressure * 1	1/1708 (0.06%)	0/1709 (0.00%)
Orthostatic hypotension * 1	2/1708 (0.12%)	1/1709 (0.06%)
Pelvic venous thrombosis * 1	1/1708 (0.06%)	0/1709 (0.00%)
Peripheral artery thrombosis * 1	1/1708 (0.06%)	1/1709 (0.06%)
Peripheral ischaemia * 1	1/1708 (0.06%)	0/1709 (0.00%)
Shock * 1	1/1708 (0.06%)	0/1709 (0.00%)
Shock haemorrhagic * 1	3/1708 (0.18%)	0/1709 (0.00%)
Subclavian vein thrombosis * 1	0/1708 (0.00%)	1/1709 (0.06%)
Thrombophlebitis superficial * 1	2/1708 (0.12%)	0/1709 (0.00%)
Venous thrombosis limb * 1	1/1708 (0.06%)	1/1709 (0.06%)
1 Term from vocabulary, MedDRA v22.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Staphylococcus Aureus 4-antigen (SA4Ag)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1530/1708 (89.58%)	1489/1709 (87.13%)
Blood and lymphatic system disorders
Anaemia * 1	97/1708 (5.68%)	122/1709 (7.14%)
Blood loss anaemia * 1	58/1708 (3.40%)	42/1709 (2.46%)
Leukocytosis * 1	18/1708 (1.05%)	20/1709 (1.17%)
Thrombocytopenia * 1	26/1708 (1.52%)	23/1709 (1.35%)
Cardiac disorders
Tachycardia * 1	32/1708 (1.87%)	30/1709 (1.76%)
Gastrointestinal disorders
Constipation * 1	201/1708 (11.77%)	192/1709 (11.23%)
Diarrhoea 1 * 1	31/1708 (1.81%)	30/1709 (1.76%)
Nausea * 1	162/1708 (9.48%)	140/1709 (8.19%)
Vomiting 1 * 1	80/1708 (4.68%)	67/1709 (3.92%)
Diarrhoea 2 † 1	287/1708 (16.80%)	270/1709 (15.80%)
Vomiting 2 † 1	45/1708 (2.63%)	55/1709 (3.22%)
General disorders
Chest pain * 1	18/1708 (1.05%)	13/1709 (0.76%)
Oedema peripheral * 1	22/1708 (1.29%)	29/1709 (1.70%)
Pyrexia 1 * 1	121/1708 (7.08%)	114/1709 (6.67%)
Fatigue † 1	732/1708 (42.86%)	681/1709 (39.85%)
Injection site erythema † 1	156/1708 (9.13%)	16/1709 (0.94%)
Injection site pain † 1	408/1708 (23.89%)	142/1709 (8.31%)
Injection site swelling † 1	135/1708 (7.90%)	17/1709 (0.99%)
Pyrexia 2 † 1	34/1708 (1.99%)	23/1709 (1.35%)
Infections and infestations
Nasopharyngitis * 1	28/1708 (1.64%)	23/1709 (1.35%)
Urinary tract infection * 1	96/1708 (5.62%)	103/1709 (6.03%)
Injury, poisoning and procedural complications
Anaemia postoperative * 1	109/1708 (6.38%)	108/1709 (6.32%)
Dural tear * 1	60/1708 (3.51%)	73/1709 (4.27%)
Fall * 1	60/1708 (3.51%)	44/1709 (2.57%)
Incision site pain * 1	67/1708 (3.92%)	63/1709 (3.69%)
Procedural pain * 1	92/1708 (5.39%)	84/1709 (4.92%)
Wound complication * 1	19/1708 (1.11%)	21/1709 (1.23%)
Metabolism and nutrition disorders
Hyperglycaemia * 1	28/1708 (1.64%)	25/1709 (1.46%)
Hypokalaemia * 1	24/1708 (1.41%)	18/1709 (1.05%)
Hyponatraemia * 1	22/1708 (1.29%)	20/1709 (1.17%)
Musculoskeletal and connective tissue disorders
Arthralgia 1 * 1	27/1708 (1.58%)	29/1709 (1.70%)
Back pain * 1	39/1708 (2.28%)	36/1709 (2.11%)
Muscle spasms * 1	21/1708 (1.23%)	30/1709 (1.76%)
Muscular weakness * 1	25/1708 (1.46%)	24/1709 (1.40%)
Musculoskeletal pain * 1	24/1708 (1.41%)	20/1709 (1.17%)
Pain in extremity * 1	55/1708 (3.22%)	59/1709 (3.45%)
Arthralgia 2 † 1	465/1708 (27.22%)	435/1709 (25.45%)
Myalgia (muscle pain) † 1	472/1708 (27.63%)	442/1709 (25.86%)
Nervous system disorders
Dizziness * 1	30/1708 (1.76%)	35/1709 (2.05%)
Headache 1 * 1	33/1708 (1.93%)	26/1709 (1.52%)
Hypoaesthesia * 1	50/1708 (2.93%)	38/1709 (2.22%)
Paraesthesia * 1	24/1708 (1.41%)	12/1709 (0.70%)
Headache 2 † 1	549/1708 (32.14%)	526/1709 (30.78%)
Psychiatric disorders
Insomnia * 1	68/1708 (3.98%)	63/1709 (3.69%)
Renal and urinary disorders
Acute kidney injury * 1	24/1708 (1.41%)	13/1709 (0.76%)
Urinary retention * 1	58/1708 (3.40%)	59/1709 (3.45%)
Respiratory, thoracic and mediastinal disorders
Atelectasis * 1	10/1708 (0.59%)	21/1709 (1.23%)
Cough * 1	8/1708 (0.47%)	19/1709 (1.11%)
Hypoxia * 1	24/1708 (1.41%)	35/1709 (2.05%)
Skin and subcutaneous tissue disorders
Erythema * 1	57/1708 (3.34%)	61/1709 (3.57%)
Pruritus * 1	27/1708 (1.58%)	33/1709 (1.93%)
Rash * 1	21/1708 (1.23%)	15/1709 (0.88%)
Vascular disorders
Hypertension * 1	15/1708 (0.88%)	20/1709 (1.17%)
Hypotension * 1	79/1708 (4.63%)	84/1709 (4.92%)
1 Term from vocabulary, MedDRA v22.0; * Indicates events were collected by non-systematic assessment; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02388165
• Other Study ID Numbers: B3451002; 2014-002644-40 ( EudraCT Number ); 6123K1-2001 ( Other Identifier: Alias Study Number ); STRIVE ( Other Identifier: Alias Study Number )
• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Results First Submitted: June 5, 2020
• Results First Posted: September 2, 2020
• Last Update Posted: January 5, 2021