Clinical trial NCT02492958: SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Staphylococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Japanese male and female adults aged 20 to \<86 years,
2. Determined as healthy by the investigator (Subjects with preexisting chronic medical conditions determined to be stable may be included),
3. Must be available for the 12 month duration of the study,
4. 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).

Exclusion Criteria:

1. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components,
2. Unstable or serious chronic medical condition that would increase the subject's risk of participation,
3. Immune system suppression or treatment with medications that suppress the immune system,
4. Receipt of blood products or immunoglobulins within the past 12 months,
5. Any infection proven or suspected to be caused by S.aureus within the past 6 months,
6. 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,
7. Living in a nursing home, long-term care facility or other institution or requiring any types of nursing care,
8. A pregnant or a breast feeding woman.

Primary outcomes:
measure: Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination
timeFrame: Day 1 up to Day 14
measure: Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination
timeFrame: Day 1 up to Day 14
measure: Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination
timeFrame: Day 1 up to Day 14
measure: Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination
timeFrame: Day 1 up to Day 14
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit
timeFrame: Day 1 up to Day 29
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12
timeFrame: After Day 29 up to Month 12
measure: Percentage of Participants With Hematology Abnormalities at Day 5
timeFrame: Day 5
measure: Percentage of Participants With Hematology Abnormalities at Day 15
timeFrame: Day 15
measure: Percentage of Participants With Coagulation Abnormalities at Day 5
timeFrame: Day 5
measure: Percentage of Participants With Coagulation Abnormalities at Day 15
timeFrame: Day 15
measure: Percentage of Participants With Blood Chemistry Abnormalities at Day 5
timeFrame: Day 5
measure: Percentage of Participants With Blood Chemistry Abnormalities at Day 15
timeFrame: Day 15
measure: Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29
timeFrame: Day 29
Secondary outcomes:
measure: Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3
timeFrame: Baseline, Day 11, 15 and Month3
measure: Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)
timeFrame: Baseline, Day 11, 15, 29 and Month 3
measure: Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
timeFrame: Baseline, Day 11, 15, 29 and Month 3
measure: Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)
timeFrame: Baseline, Day 11, 15, 29 and Month 3
measure: Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3
timeFrame: Baseline, Day 11, 15, 29 and Month 3
measure: Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3
timeFrame: Baseline, Day 11, 15, 29 and Month 3
measure: Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3
timeFrame: Baseline, Day 11, 15, 29 and Month 3
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
state: Tokyo
city: Fukuoka
country: Japan
facility: SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: