Staphylococcal InfectionsPhase 2NCT02492958

SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

A Phase 2 study testing Staphylococcus aureus 4-antigen vaccine in people with Staphylococcal Infections, run by Pfizer at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86 years. Read more about this study

Who is it for?: Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Staphylococcal Infections
What is being tested?: Staphylococcus aureus 4-antigen vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 136 participants
Where: 2 sitesJapan
Study dates: Jun 2015to Sep 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Japanese male and female adults aged 20 to <86 years,
Determined as healthy by the investigator (Subjects with preexisting chronic medical conditions determined to be stable may be included),
Must be available for the 12 month duration of the study,
Subjects must agree to use an acceptable method of birth control for 3 months after study vaccination (if the subject or the subject's partner are/is capable of having children).

Who cannot join

Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components,
Unstable or serious chronic medical condition that would increase the subject's risk of participation,
Immune system suppression or treatment with medications that suppress the immune system,
Receipt of blood products or immunoglobulins within the past 12 months,
Any infection proven or suspected to be caused by S.aureus within the past 6 months,
A staff member at this site nor a relative of those site staff members, nor a sponsor's employee directly involved in the conduct of this research study,
Living in a nursing home, long-term care facility or other institution or requiring any types of nursing care,
A pregnant or a breast feeding woman.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
Fukuoka, 812-0025
SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
Sumida-ku, Tokyo, 130-0004

Other trials in Japan

About this study

Official title: A Phase 1/2a Placebo-controlled, Randomized, Double-blind, Sponsor-unblinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of Staphylococcus Aureus 4-antigen Vaccine (sa4ag) In Japanese Adults

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86 years.

Conditions: Staphylococcal Infections
Being tested: Staphylococcus aureus 4-antigen vaccine, Placebo
Medical subject headings: Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Staphylococcus aureus 4-antigen vaccineBiological
Also called SA4Ag
a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
PlaceboBiological
a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm

Study groups in NCT02492958
Study group	Role	What they receive
SA4Ag	Experimental	Staphylococcus aureus 4-antigen vaccine Receives: Biological: Staphylococcus aureus 4-antigen vaccine
Placebo	Placebo comparator	a lyophile match to the vaccine, consisting of excipients of SA4Ag formulation minus the active ingredients Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination
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.
Measured: Day 1 up to Day 14
Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination
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).
Measured: Day 1 up to Day 14
Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination
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.
Measured: Day 1 up to Day 14
Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination
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).
Measured: Day 1 up to Day 14
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit
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.
Measured: Day 1 up to Day 29
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12
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.
Measured: After Day 29 up to Month 12
Percentage of Participants With Hematology Abnormalities at Day 5
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.
Measured: Day 5
Percentage of Participants With Hematology Abnormalities at Day 15
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.
Measured: Day 15
Percentage of Participants With Coagulation Abnormalities at Day 5
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.
Measured: Day 5
Percentage of Participants With Coagulation Abnormalities at Day 15
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.
Measured: Day 15
Percentage of Participants With Blood Chemistry Abnormalities at Day 5
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.
Measured: Day 5
Percentage of Participants With Blood Chemistry Abnormalities at Day 15
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.
Measured: Day 15
Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29
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.
Measured: Day 29

Secondary outcomes (7)

Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3
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.
Measured: Baseline, Day 11, 15 and Month3
Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)
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.
Measured: Baseline, Day 11, 15, 29 and Month 3
Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
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.
Measured: Baseline, Day 11, 15, 29 and Month 3
Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)
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.
Measured: Baseline, Day 11, 15, 29 and Month 3
Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3
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.
Measured: Baseline, Day 11, 15, 29 and Month 3
Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3
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.
Measured: Baseline, Day 11, 15, 29 and Month 3
Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3
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.
Measured: Baseline, Day 11, 15, 29 and Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Sep 2016

First posted9 Jul 2015 (estimated)
Study startJun 2015
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02492958
Sponsor's protocol ID: B3451003
Other IDs: 6123K1-1006
Status last verified: Jul 2018
First submitted: 29 May 2015
Last updated: 30 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Staphylococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Placebo-controlled, Randomized, Double-blind, Sponsor-unblinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of Staphylococcus Aureus 4-antigen Vaccine (sa4ag) In Japanese Adults
ClinicalTrials.gov ID: NCT02492958
Acronym / sponsor ID: B3451003
Conditions: Staphylococcal Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2015 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 9 Jul 2015 (estimated)
Results: Posted 30 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86 years.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SA4Ag	Experimental	Biological: Staphylococcus aureus 4-antigen vaccineStaphylococcus aureus 4-antigen vaccine
Placebo	Placebo comparator	Biological: Placeboa lyophile match to the vaccine, consisting of excipients of SA4Ag formulation minus the active ingredients

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Japanese male and female adults aged 20 to <86 years,
Determined as healthy by the investigator (Subjects with preexisting chronic medical conditions determined to be stable may be included),
Must be available for the 12 month duration of the study,
Subjects must agree to use an acceptable method of birth control for 3 months after study vaccination (if the subject or the subject's partner are/is capable of having children).

Key exclusion criteria (8 listed)

Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components,
Unstable or serious chronic medical condition that would increase the subject's risk of participation,
Immune system suppression or treatment with medications that suppress the immune system,
Receipt of blood products or immunoglobulins within the past 12 months,
Any infection proven or suspected to be caused by S.aureus within the past 6 months,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Staphylococcus aureus 4-antigen vaccineAlso: SA4Aga single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm	Biological	SA4Ag
Placeboa single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm	Biological	Placebo

Primary outcome

Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination
Time frame: Day 1 up to Day 14
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.
Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination
Time frame: Day 1 up to Day 14
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).
Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination
Time frame: Day 1 up to Day 14
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.
Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination
Time frame: Day 1 up to Day 14
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).
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit
Time frame: Day 1 up to Day 29
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.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12
Time frame: After Day 29 up to Month 12
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.
Percentage of Participants With Hematology Abnormalities at Day 5
Time frame: Day 5
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.
Percentage of Participants With Hematology Abnormalities at Day 15
Time frame: Day 15
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.
Percentage of Participants With Coagulation Abnormalities at Day 5
Time frame: Day 5
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.
Percentage of Participants With Coagulation Abnormalities at Day 15
Time frame: Day 15
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.
Percentage of Participants With Blood Chemistry Abnormalities at Day 5
Time frame: Day 5
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.
Percentage of Participants With Blood Chemistry Abnormalities at Day 15
Time frame: Day 15
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.
Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29
Time frame: Day 29
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.

7 secondary outcomes

Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3
Time frame: Baseline, Day 11, 15 and Month3
Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)
Time frame: Baseline, Day 11, 15, 29 and Month 3
Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Time frame: Baseline, Day 11, 15, 29 and Month 3
Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)
Time frame: Baseline, Day 11, 15, 29 and Month 3
Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3
Time frame: Baseline, Day 11, 15, 29 and Month 3
Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3
Time frame: Baseline, Day 11, 15, 29 and Month 3
Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3
Time frame: Baseline, Day 11, 15, 29 and Month 3

Results and safety

Results posted to the registry on 30 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (20 to <65 Years)	34	33
SA4Ag (20 to <65 Years)	34	34
Placebo (65 to <86 Years)	34	32
SA4Ag (65 to <86 Years)	34	34

Primary outcome: Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination

Time frame: Day 1 up to Day 14. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo (20 to <65 Years) n = 34	SA4Ag (20 to <65 Years) n = 34	Placebo (65 to <86 Years) n = 34	SA4Ag (65 to <86 Years) n = 34
Value	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)

Population analysed: Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.

Primary outcome: Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination

Time frame: Day 1 up to Day 14. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo (20 to <65 Years) n = 34	SA4Ag (20 to <65 Years) n = 34	Placebo (65 to <86 Years) n = 34	SA4Ag (65 to <86 Years) n = 34
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)

Population analysed: Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.

Primary outcome: Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination

Time frame: Day 1 up to Day 14. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo (20 to <65 Years) n = 34	SA4Ag (20 to <65 Years) n = 34	Placebo (65 to <86 Years) n = 34	SA4Ag (65 to <86 Years) n = 34
Value	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)

Population analysed: Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.

Primary outcome: Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination

Time frame: Day 1 up to Day 14. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo (20 to <65 Years) n = 34	SA4Ag (20 to <65 Years) n = 34	Placebo (65 to <86 Years) n = 34	SA4Ag (65 to <86 Years) n = 34
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)

Population analysed: Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (20 to <65 Years)	1 of 34 (2.9%)	11 of 34 (32.4%)	Not reported
SA4Ag (20 to <65 Years)	0 of 34 (0%)	13 of 34 (38.2%)	Not reported
Placebo (65 to <86 Years)	2 of 34 (5.9%)	8 of 34 (23.5%)	Not reported
SA4Ag (65 to <86 Years)	3 of 34 (8.8%)	17 of 34 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Staphylococcus aureus 4-antigen vaccine in people with Staphylococcal Infections, run by Pfizer at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination (time frame: Day 1 up to Day 14). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02492958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.