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SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02492958
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Staphylococcal Infections
Interventions Biological: Staphylococcus aureus 4-antigen vaccine
Biological: Placebo
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Period Title: Overall Study
Started 34 34 34 34
Completed 33 34 32 34
Not Completed 1 0 2 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0
Adverse Event             1             0             1             0
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years) Total
Hide Arm/Group Description Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Total of all reporting groups
Overall Number of Baseline Participants 34 34 34 34 136
Hide Baseline Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 34 participants 34 participants 136 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
34
 100.0%
0
   0.0%
0
   0.0%
68
  50.0%
>=65 years
0
   0.0%
0
   0.0%
34
 100.0%
34
 100.0%
68
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 34 participants 34 participants 136 participants
Female
19
  55.9%
15
  44.1%
21
  61.8%
13
  38.2%
68
  50.0%
Male
15
  44.1%
19
  55.9%
13
  38.2%
21
  61.8%
68
  50.0%
1.Primary Outcome
Title Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination
Hide Description Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were defined 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 injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). In this outcome measure percentage of participants with any local reaction was reported.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.9
(0.1 to 15.3)
20.6
(8.7 to 37.9)
5.9
(0.7 to 19.7)
29.4
(15.1 to 47.5)
2.Primary Outcome
Title Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination
Hide Description Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (5.5 to 10.0 cm) and, severe (>=10.5 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Redness: Mild
2.9
(0.1 to 15.3)
2.9
(0.1 to 15.3)
2.9
(0.1 to 15.3)
5.9
(0.7 to 19.7)
Redness: Moderate
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
Redness: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
2.9
(0.1 to 15.3)
Swelling: Mild
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
0.0
(0.0 to 10.3)
Swelling: Moderate
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
8.8
(1.9 to 23.7)
Swelling: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Pain: Mild
0.0
(0.0 to 10.3)
17.6
(6.8 to 34.5)
2.9
(0.1 to 15.3)
14.7
(5.0 to 31.1)
Pain: Moderate
0.0
(0.0 to 10.3)
2.9
(0.1 to 15.3)
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
Pain: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
3.Primary Outcome
Title Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination
Hide Description Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 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 (significant, prevented daily activity). In this outcome measure percentage of participants with any systemic event was reported.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
29.4
(15.1 to 47.5)
29.4
(15.1 to 47.5)
17.6
(6.8 to 34.5)
35.3
(19.7 to 53.5)
4.Primary Outcome
Title Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination
Hide Description Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >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 (significant, prevented daily activity).
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fever: 37.5 degree C-38.4 degree C
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
2.9
(0.1 to 15.3)
5.9
(0.7 to 19.7)
Fever: 38.5 degree C-38.9 degree C
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Fever: 39.0 degree C-40.0 degree C
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Fever: >40.0 degree C
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Fatigue: Mild
8.8
(1.9 to 23.7)
8.8
(1.9 to 23.7)
5.9
(0.7 to 19.7)
11.8
(3.3 to 27.5)
Fatigue: Moderate
5.9
(0.7 to 19.7)
2.9
(0.1 to 15.3)
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
Fatigue: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Headache: Mild
5.9
(0.7 to 19.7)
11.8
(3.3 to 27.5)
2.9
(0.1 to 15.3)
5.9
(0.7 to 19.7)
Headache: Moderate
5.9
(0.7 to 19.7)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
2.9
(0.1 to 15.3)
Headache: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Vomiting: Mild
2.9
(0.1 to 15.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Vomiting: Moderate
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Vomiting: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Diarrhea: Mild
14.7
(5.0 to 31.1)
5.9
(0.7 to 19.7)
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
Diarrhea: Moderate
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Diarrhea: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Muscle Pain: Mild
0.0
(0.0 to 10.3)
2.9
(0.1 to 15.3)
8.8
(1.9 to 23.7)
8.8
(1.9 to 23.7)
Muscle Pain: Moderate
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
Muscle Pain: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
Joint Pain: Mild
0.0
(0.0 to 10.3)
2.9
(0.1 to 15.3)
0.0
(0.0 to 10.3)
5.9
(0.7 to 19.7)
Joint Pain: Moderate
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
2.9
(0.1 to 15.3)
Joint Pain: Severe
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
0.0
(0.0 to 10.3)
5.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit
Hide Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious AEs. Treatment-emergent AEs were events between the administration of investigational product and up to Day 29 that were absent before vaccination or that worsened relative to pre-administration state.
Time Frame Day 1 up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Unit of Measure: Percentage of participants
5.9 2.9 5.9 5.9
6.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12
Hide Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or deemed medically significant for any other reason. A treatment emergent AE was defined as an event that emerged during the study that was absent before administration of investigational product, or worsened relative to the pre-administration state. AEs reported during this time period included both SAEs and newly diagnosed chronic medical disorders (NDCMD). A NDCMD was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Time Frame After Day 29 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Unit of Measure: Percentage of participants
AEs 2.9 0.0 5.9 11.8
SAEs 2.9 0.0 5.9 8.8
7.Primary Outcome
Title Percentage of Participants With Hematology Abnormalities at Day 5
Hide Description Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here 'number of participants analyzed (N)' signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
Hemoglobin 0.0 16.7 0.0 0.0
White Blood Cells 0.0 16.7 0.0 0.0
Neutrophils 0.0 33.3 0.0 16.7
Platelets 0.0 0.0 0.0 0.0
8.Primary Outcome
Title Percentage of Participants With Hematology Abnormalities at Day 15
Hide Description Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
Hemoglobin 16.7 50.0 0.0 16.7
White Blood Cells 0.0 33.3 0.0 0.0
Neutrophils 0.0 33.3 0.0 16.7
Platelets 0.0 0.0 0.0 0.0
9.Primary Outcome
Title Percentage of Participants With Coagulation Abnormalities at Day 5
Hide Description Coagulation analysis included the following parameters: prothrombin time (PT), activated partial thromboplastin time (APTT), platelet aggregation (AGG) (with adenosine diphosphate [ADP], with arachidonic acid, and with collagen) and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
PT 0.0 0.0 0.0 0.0
APTT 0.0 0.0 0.0 0.0
Platelet AGG: ADP 0.0 0.0 0.0 0.0
Platelet AGG: Arachidonic acid 0.0 0.0 33.3 0.0
Platelet AGG: Collagen 0.0 0.0 0.0 0.0
Fibrinogen Activity 0.0 0.0 0.0 16.7
10.Primary Outcome
Title Percentage of Participants With Coagulation Abnormalities at Day 15
Hide Description Coagulation analysis included the following parameters: PT, APTT, platelet AGG with ADP, platelet AGG with arachidonic acid, platelet AGG with collagen and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
PT 0.0 0.0 0.0 0.0
APTT 0.0 0.0 0.0 0.0
Platelet AGG: ADP 0.0 0.0 0.0 0.0
Platelet AGG: Arachidonic acid 0.0 0.0 0.0 16.7
Platelet AGG: Collagen 0.0 0.0 0.0 0.0
Fibrinogen Activity 0.0 0.0 0.0 0.0
11.Primary Outcome
Title Percentage of Participants With Blood Chemistry Abnormalities at Day 5
Hide Description Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
Alanine Aminotransferase 0.0 0.0 0.0 0.0
Aspartate Aminotransferase 0.0 0.0 0.0 0.0
Alkaline Phosphatase 0.0 0.0 0.0 16.7
Bilirubin 0.0 16.7 0.0 0.0
Creatinine 0.0 0.0 0.0 0.0
Creatine Kinase 0.0 33.3 0.0 0.0
Lactate Dehydrogenase 16.7 16.7 0.0 16.7
12.Primary Outcome
Title Percentage of Participants With Blood Chemistry Abnormalities at Day 15
Hide Description Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
Alanine Aminotransferase 0.0 0.0 0.0 0.0
Aspartate Aminotransferase 0.0 0.0 0.0 0.0
Alkaline Phosphatase 0.0 0.0 0.0 16.7
Bilirubin 0.0 0.0 16.7 0.0
Creatinine 0.0 0.0 0.0 0.0
Creatine Kinase 0.0 0.0 16.7 0.0
Lactate Dehydrogenase 16.7 0.0 16.7 16.7
13.Primary Outcome
Title Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29
Hide Description Percentage of participants achieving predefined antibody response to capsular polysaccharide serotype 5 (CP5), capsular polysaccharide serotype 8 (CP8), clumping factor A (ClfA) and manganese transporter C (MntC) at Day 29 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on opsonophagocytic activity (OPA) assay for CP5 and CP8, respectively; was 121 based on fibrinogen-binding inhibition (FBI) assay for ClfA and 512 based on competitive Luminex immunoassay (cLIA) for MntC.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies the number of participants who were evaluable for specific antigens for each arm, respectively.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
CP5 Number Analyzed 31 participants 34 participants 32 participants 34 participants
25.8
(11.9 to 44.6)
100.0
(89.7 to 100.0)
15.6
(5.3 to 32.8)
100.0
(89.7 to 100.0)
CP8 Number Analyzed 34 participants 34 participants 34 participants 34 participants
17.6
(6.8 to 34.5)
100.0
(89.7 to 100.0)
20.6
(8.7 to 37.9)
94.1
(80.3 to 99.3)
ClfA Number Analyzed 34 participants 34 participants 34 participants 34 participants
8.8
(1.9 to 23.7)
94.1
(80.3 to 99.3)
5.9
(0.7 to 19.7)
88.2
(72.5 to 96.7)
MntC Number Analyzed 34 participants 34 participants 34 participants 34 participants
2.9
(0.1 to 15.3)
91.2
(76.3 to 98.1)
8.8
(1.9 to 23.7)
94.1
(80.3 to 99.3)
14.Secondary Outcome
Title Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3
Hide Description Percentage of participants achieving predefined antibody response to CP5, CP8, ClfA and MntC at Baseline, Day 11, 15 and Month 3 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on OPA assay for CP5 and CP8, respectively; was 121 based on FBI assay for ClfA, 512 based on cLIA for MntC.
Time Frame Baseline, Day 11, 15 and Month3
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies the number of participants who were evaluable for specific antigens for each arm, respectively.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline: CP5 Number Analyzed 34 participants 34 participants 34 participants 34 participants
20.6
(8.7 to 37.9)
23.5
(10.7 to 41.2)
11.8
(3.3 to 27.5)
14.7
(5.0 to 31.1)
Baseline: CP8 Number Analyzed 33 participants 33 participants 34 participants 34 participants
15.2
(5.1 to 31.9)
33.3
(18.0 to 51.8)
20.6
(8.7 to 37.9)
26.5
(12.9 to 44.4)
Baseline: ClfA Number Analyzed 34 participants 34 participants 34 participants 34 participants
11.8
(3.3 to 27.5)
0.0
(0.0 to 10.3)
2.9
(0.1 to 15.3)
0.0
(0.0 to 10.3)
Baseline: MntC Number Analyzed 34 participants 34 participants 34 participants 34 participants
2.9
(0.1 to 15.3)
23.5
(10.7 to 41.2)
8.8
(1.9 to 23.7)
11.8
(3.3 to 27.5)
Day 11: CP5 Number Analyzed 34 participants 33 participants 33 participants 34 participants
20.6
(8.7 to 37.9)
100.0
(89.4 to 100.0)
18.2
(7.0 to 35.5)
100.0
(89.7 to 100.0)
Day 11: CP8 Number Analyzed 33 participants 34 participants 34 participants 34 participants
18.2
(7.0 to 35.5)
100.0
(89.7 to 100.0)
20.6
(8.7 to 37.9)
94.1
(80.3 to 99.3)
Day 11: ClfA Number Analyzed 34 participants 34 participants 34 participants 34 participants
11.8
(3.3 to 27.5)
97.1
(84.7 to 99.9)
2.9
(0.1 to 15.3)
82.4
(65.5 to 93.2)
Day 11: MntC Number Analyzed 34 participants 34 participants 34 participants 34 participants
2.9
(0.1 to 15.3)
94.1
(80.3 to 99.3)
8.8
(1.9 to 23.7)
97.1
(84.7 to 99.9)
Day 15: CP5 Number Analyzed 33 participants 34 participants 33 participants 34 participants
21.2
(9.0 to 38.9)
100.0
(89.7 to 100.0)
9.1
(1.9 to 24.3)
100.0
(89.7 to 100.0)
Day 15: CP8 Number Analyzed 32 participants 34 participants 34 participants 34 participants
18.8
(7.2 to 36.4)
100.0
(89.7 to 100.0)
20.6
(8.7 to 37.9)
97.1
(84.7 to 99.9)
Day 15: ClfA Number Analyzed 34 participants 34 participants 34 participants 34 participants
11.8
(3.3 to 27.5)
97.1
(84.7 to 99.9)
5.9
(0.7 to 19.7)
88.2
(72.5 to 96.7)
Day 15: MntC Number Analyzed 34 participants 34 participants 34 participants 34 participants
2.9
(0.1 to 15.3)
94.1
(80.3 to 99.3)
17.6
(6.8 to 34.5)
97.1
(84.7 to 99.9)
Month 3: CP5 Number Analyzed 32 participants 34 participants 34 participants 34 participants
18.8
(7.2 to 36.4)
100.0
(89.7 to 100.0)
20.6
(8.7 to 37.9)
100.0
(89.7 to 100.0)
Month 3: CP8 Number Analyzed 34 participants 34 participants 34 participants 34 participants
20.6
(8.7 to 37.9)
100.0
(89.7 to 100.0)
14.7
(5.0 to 31.1)
88.2
(72.5 to 96.7)
Month 3: ClfA Number Analyzed 34 participants 34 participants 34 participants 34 participants
2.9
(0.1 to 15.3)
88.2
(72.5 to 96.7)
2.9
(0.1 to 15.3)
82.4
(65.5 to 93.2)
Month 3: MntC Number Analyzed 34 participants 34 participants 34 participants 34 participants
2.9
(0.1 to 15.3)
76.5
(58.8 to 89.3)
14.7
(5.0 to 31.1)
82.4
(65.5 to 93.2)
15.Secondary Outcome
Title Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)
Hide Description Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by cLIA for ClfA and MntC and corresponding 2-sided 95 percent (%) confidence intervals (CIs) were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.
Time Frame Baseline, Day 11, 15, 29 and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Baseline: ClfA
200.7
(177.6 to 226.8)
218.1
(196.7 to 241.7)
216.6
(179.7 to 261.0)
174.0
(150.3 to 201.4)
Baseline: MntC
349.4
(306.8 to 398.0)
376.8
(316.5 to 448.5)
321.4
(270.6 to 381.7)
334.8
(291.6 to 384.3)
Day 11: ClfA
190.7
(166.1 to 218.9)
4105.2
(2389.4 to 7053.0)
203.7
(172.2 to 241.0)
3394.1
(2029.3 to 5676.8)
Day 11: MntC
358.5
(312.2 to 411.6)
5019.6
(3207.2 to 7856.2)
313.6
(260.9 to 377.0)
6712.9
(4385.4 to 10275.6)
Day 15: ClfA
198.7
(172.2 to 229.2)
4706.0
(2802.7 to 7902.1)
231.9
(199.1 to 270.1)
4571.3
(2883.1 to 7248.1)
Day 15: MntC
351.4
(312.2 to 395.6)
4431.7
(2896.0 to 6781.7)
356.0
(297.8 to 425.5)
5710.0
(3816.9 to 8541.9)
Day 29: ClfA
198.4
(173.7 to 226.6)
3815.0
(2288.8 to 6359.0)
182.5
(149.4 to 223.1)
3313.6
(2155.0 to 5095.3)
Day 29: MntC
326.9
(287.2 to 371.9)
2920.8
(1947.4 to 4380.8)
281.4
(235.8 to 335.7)
3471.0
(2397.3 to 5025.5)
Month 3: ClfA
201.6
(177.3 to 229.2)
2309.3
(1492.9 to 3572.3)
224.8
(190.8 to 264.8)
2054.8
(1348.3 to 3131.6)
Month 3: MntC
316.3
(275.6 to 363.0)
1273.5
(912.1 to 1778.0)
384.1
(329.9 to 447.2)
1528.7
(1112.2 to 2101.1)
16.Secondary Outcome
Title Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Hide Description Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by OPA for CP5 and CP8 and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.
Time Frame Baseline, Day 11, 15, 29 and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies number of participants who were evaluable for specific antigens for each arm, respectively.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Baseline: CP5 Number Analyzed 34 participants 34 participants 34 participants 34 participants
355.1
(227.7 to 553.8)
301.7
(197.4 to 461.0)
349.0
(249.2 to 488.9)
332.9
(223.9 to 495.1)
Baseline: CP8 Number Analyzed 33 participants 33 participants 34 participants 34 participants
512.9
(338.4 to 777.5)
702.5
(407.8 to 1210.1)
337.3
(195.7 to 581.3)
388.6
(222.6 to 678.3)
Day 11: CP5 Number Analyzed 34 participants 33 participants 33 participants 34 participants
360.6
(231.7 to 561.1)
37617.8
(27863.0 to 50787.8)
342.0
(231.1 to 506.2)
31066.0
(20279.0 to 47591.1)
Day 11: CP8 Number Analyzed 33 participants 34 participants 34 participants 34 participants
567.9
(372.3 to 866.3)
27501.3
(19669.7 to 38451.2)
351.2
(205.9 to 598.9)
16214.6
(8218.2 to 31991.7)
Day 15: CP5 Number Analyzed 33 participants 34 participants 33 participants 34 participants
354.9
(236.9 to 531.9)
26677.0
(20149.0 to 35319.9)
331.3
(231.2 to 474.9)
31706.4
(21585.9 to 46571.8)
Day 15: CP8 Number Analyzed 32 participants 34 participants 34 participants 34 participants
514.7
(333.8 to 793.5)
25403.8
(18448.2 to 34981.9)
326.6
(193.6 to 551.1)
24039.8
(13014.0 to 44407.0)
Day 29: CP5 Number Analyzed 31 participants 34 participants 32 participants 34 participants
432.6
(275.3 to 679.8)
25026.5
(18911.3 to 33119.1)
350.1
(241.8 to 506.9)
29639.2
(20983.3 to 41865.7)
Day 29: CP8 Number Analyzed 34 participants 34 participants 34 participants 34 participants
544.5
(362.0 to 819.1)
23453.9
(16904.7 to 32540.3)
336.4
(195.7 to 578.3)
16542.0
(9489.2 to 28836.7)
Month 3: CP5 Number Analyzed 32 participants 34 participants 34 participants 34 participants
410.0
(266.1 to 631.8)
14679.2
(11032.9 to 19530.7)
339.8
(238.9 to 483.4)
16000.3
(11448.0 to 22362.8)
Month 3: CP8 Number Analyzed 34 participants 34 participants 34 participants 34 participants
504.1
(327.4 to 776.2)
11856.2
(8663.2 to 16226.1)
308.5
(187.1 to 508.7)
7881.5
(4521.6 to 13738.1)
17.Secondary Outcome
Title Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)
Hide Description Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by FBI for ClfA and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.
Time Frame Baseline, Day 11, 15, 29 and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Baseline
67.2
(60.5 to 74.7)
60.5 [1] 
(NA to NA)
63.3
(57.7 to 69.4)
60.5 [1] 
(NA to NA)
Day 11
68.4
(59.7 to 78.3)
755.5
(468.1 to 1219.2)
63.3
(57.7 to 69.4)
620.1
(367.8 to 1045.6)
Day 15
69.9
(60.2 to 81.2)
868.5
(544.1 to 1386.3)
64.6
(58.7 to 71.1)
706.8
(421.2 to 1185.9)
Day 29
68.1
(59.1 to 78.5)
748.4
(473.0 to 1184.4)
65.2
(58.6 to 72.5)
620.7
(396.5 to 971.8)
Month 3
64.0
(57.1 to 71.8)
474.5
(309.7 to 726.9)
63.1
(57.9 to 68.8)
384.8
(256.1 to 578.3)
[1]
CI was not estimated due to the lack of variability of GMT.
18.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3
Hide Description GMFRs of anti-Staphylococcus aureus cLIA for ClfA and MntC were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.
Time Frame Baseline, Day 11, 15, 29 and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold rise
Day 11: ClfA
1.0
(0.9 to 1.0)
18.8
(11.0 to 32.1)
0.9
(0.9 to 1.0)
19.5
(12.0 to 31.8)
Day 11: MntC
1.0
(0.9 to 1.1)
13.3
(9.0 to 19.8)
1.0
(0.9 to 1.1)
20.1
(13.2 to 30.5)
Day 15: ClfA
1.0
(0.9 to 1.1)
21.6
(13.0 to 35.7)
1.1
(1.0 to 1.2)
26.3
(17.0 to 40.5)
Day 15: MntC
1.0
(0.9 to 1.1)
11.8
(8.1 to 17.1)
1.1
(1.0 to 1.3)
17.1
(11.5 to 25.3)
Day 29: ClfA
1.0
(0.9 to 1.1)
17.5
(10.7 to 28.7)
0.8
(0.8 to 0.9)
19.0
(12.8 to 28.4)
Day 29: MntC
0.9
(0.8 to 1.1)
7.8
(5.5 to 10.9)
0.9
(0.8 to 1.0)
10.4
(7.3 to 14.7)
Month 3: ClfA
1.0
(0.9 to 1.1)
10.6
(7.0 to 16.1)
1.0
(1.0 to 1.1)
11.8
(8.0 to 17.5)
Month 3: MntC
0.9
(0.8 to 1.0)
3.4
(2.6 to 4.4)
1.2
(1.1 to 1.4)
4.6
(3.4 to 6.1)
19.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3
Hide Description GMFRs of anti-Staphylococcus aureus OPA for CP5 and CP8 were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.
Time Frame Baseline, Day 11, 15, 29 and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here "n" signifies number of participants who were evaluable for specific antigens for each arm, respectively.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold rise
Day 11: CP5 Number Analyzed 34 participants 33 participants 33 participants 34 participants
1.0
(0.8 to 1.2)
125.0
(78.5 to 198.9)
0.9
(0.8 to 1.0)
93.3
(56.7 to 153.5)
Day 11: CP8 Number Analyzed 32 participants 33 participants 34 participants 34 participants
1.1
(1.0 to 1.3)
38.7
(21.0 to 71.3)
1.0
(0.9 to 1.1)
41.7
(20.6 to 84.6)
Day 15: CP5 Number Analyzed 33 participants 34 participants 33 participants 34 participants
1.0
(0.9 to 1.2)
88.4
(59.4 to 131.6)
0.9
(0.8 to 1.0)
95.2
(61.5 to 147.5)
Day 15: CP8 Number Analyzed 31 participants 33 participants 34 participants 34 participants
1.0
(0.9 to 1.1)
35.2
(19.1 to 64.8)
1.0
(0.9 to 1.0)
61.9
(30.8 to 124.4)
Day 29: CP5 Number Analyzed 31 participants 34 participants 32 participants 34 participants
1.1
(1.0 to 1.2)
83.0
(54.2 to 126.9)
0.9
(0.8 to 1.1)
89.0
(58.6 to 135.2)
Day 29: CP8 Number Analyzed 33 participants 33 participants 34 participants 34 participants
1.1
(1.0 to 1.2)
32.2
(17.4 to 59.5)
1.0
(1.0 to 1.0)
42.6
(22.6 to 80.4)
Month 3: CP5 Number Analyzed 32 participants 34 participants 34 participants 34 participants
1.1
(1.0 to 1.3)
48.7
(34.2 to 69.2)
1.0
(0.9 to 1.1)
48.1
(32.1 to 71.9)
Month 3: CP8 Number Analyzed 33 participants 33 participants 34 participants 34 participants
1.0
(0.9 to 1.2)
16.2
(9.6 to 27.6)
0.9
(0.8 to 1.0)
20.3
(11.5 to 35.8)
20.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3
Hide Description GMFR of anti-Staphylococcus aureus FBI for ClfA was computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.
Time Frame Baseline, Day 11, 15, 29 and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description:
Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
Overall Number of Participants Analyzed 34 34 34 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold rise
Day 11
1.0
(0.9 to 1.1)
12.5
(7.7 to 20.2)
1.0 [1] 
(NA to NA)
10.3
(6.1 to 17.3)
Day 15
1.0
(0.9 to 1.2)
14.4
(9.0 to 22.9)
1.0
(1.0 to 1.1)
11.7
(7.0 to 19.6)
Day 29
1.0
(0.9 to 1.1)
12.4
(7.8 to 19.6)
1.0
(1.0 to 1.1)
10.3
(6.6 to 16.1)
Month 3
1.0
(0.9 to 1.0)
7.8
(5.1 to 12.0)
1.0
(1.0 to 1.0)
6.4
(4.2 to 9.6)
[1]
CI was not estimated due to the lack of variability of GMFR.
Time Frame [Not Specified]
Adverse Event Reporting Description 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 study.
 
Arm/Group Title Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Hide Arm/Group Description Participants aged from 20 years to less than (<) 65 years, received a single dose of placebo matched to Staphylococcus aureus 4-antigen (SA4Ag) vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 20 years to <65 years, received a single 0.5 milliliter (mL) dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 65 years to <86 years, received a single dose of placebo matched to SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12. Participants aged from 65 years to <86 years, received a single 0.5 mL dose of SA4Ag vaccine intramuscularly on Day 1. Participants were followed up to Month 12.
All-Cause Mortality
Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/34 (2.94%)   0/34 (0.00%)   2/34 (5.88%)   3/34 (8.82%) 
Eye disorders         
Hyalosis asteroid * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Macular fibrosis * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Cataract * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Rib fracture * 1  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer * 1  1/34 (2.94%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%) 
Breast cancer * 1  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Nervous system disorders         
Carotid artery aneurysm * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Cerebral infarction * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Intracranial aneurysm * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Reproductive system and breast disorders         
Prostatitis * 1 [1]  0/15 (0.00%)  0/19 (0.00%)  0/13 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders         
Vocal cord disorder * 1  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
[1]
This event was gender specific.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (20 to <65 Years) SA4Ag (20 to <65 Years) Placebo (65 to <86 Years) SA4Ag (65 to <86 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/34 (32.35%)   13/34 (38.24%)   8/34 (23.53%)   17/34 (50.00%) 
Gastrointestinal disorders         
Diarrhea † 1  5/34 (14.71%)  2/34 (5.88%)  0/34 (0.00%)  2/34 (5.88%) 
Vomiting † 1  1/34 (2.94%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%) 
General disorders         
Fatigue † 1  5/34 (14.71%)  4/34 (11.76%)  2/34 (5.88%)  6/34 (17.65%) 
Injection site erythema † 1  1/34 (2.94%)  1/34 (2.94%)  1/34 (2.94%)  5/34 (14.71%) 
Injection site pain † 1  0/34 (0.00%)  7/34 (20.59%)  1/34 (2.94%)  7/34 (20.59%) 
Injection site pain * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Injection site swelling † 1  0/34 (0.00%)  0/34 (0.00%)  2/34 (5.88%)  3/34 (8.82%) 
Pyrexia † 1  0/34 (0.00%)  2/34 (5.88%)  1/34 (2.94%)  2/34 (5.88%) 
Infections and infestations         
Nasopharyngitis * 1  1/34 (2.94%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%) 
Upper respiratory tract infection * 1  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%)  0/34 (0.00%) 
Bronchitis * 1  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Cystitis * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%)  3/34 (8.82%) 
Myalgia † 1  0/34 (0.00%)  1/34 (2.94%)  3/34 (8.82%)  5/34 (14.71%) 
Nervous system disorders         
Headache † 1  4/34 (11.76%)  4/34 (11.76%)  1/34 (2.94%)  3/34 (8.82%) 
Migraine * 1  1/34 (2.94%)  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%) 
Headache * 1  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%)  0/34 (0.00%) 
Renal and urinary disorders         
Hypertonic bladder * 1  0/34 (0.00%)  0/34 (0.00%)  0/34 (0.00%)  1/34 (2.94%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia * 1 [1]  0/15 (0.00%)  0/19 (0.00%)  0/13 (0.00%)  1/21 (4.76%) 
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
[1]
This event was gender specific.
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02492958    
Other Study ID Numbers: B3451003
6123K1-1006 ( Other Identifier: Alias Study Number )
First Submitted: May 29, 2015
First Posted: July 9, 2015
Results First Submitted: August 15, 2017
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018