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SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

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ClinicalTrials.gov Identifier: NCT02492958
Recruitment Status : Completed
First Posted : July 9, 2015
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Staphylococcal Infections Biological: Staphylococcus aureus 4-antigen vaccine Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Start Date : June 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SA4Ag
Staphylococcus aureus 4-antigen vaccine
Biological: Staphylococcus aureus 4-antigen vaccine
a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
Other Name: SA4Ag

Placebo Comparator: Placebo
a lyophile match to the vaccine, consisting of excipients of SA4Ag formulation minus the active ingredients
Biological: Placebo
a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm




Primary Outcome Measures :
  1. Percentage of participants reporting local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries [ Time Frame: 14 days after vaccination ]
  2. Percentage of participants reporting systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle pain, and joint pain) and severity of systemic events as self-reported on electronic diaries [ Time Frame: 14 days after vaccination ]
  3. Percentage of participants reporting adverse events, newly diagnosed chronic medical disorders, and serious adverse events categorized according to the Medical Dictionary for Regulatory Activities [ Time Frame: 12 month after vaccination ]
  4. Percentage of Phase 1 participants with grading shifts in hematology, coagulation, and blood chemistry laboratory assessments [ Time Frame: 15 days after vaccination ]
  5. Percentage of Phase 1 participants with abnormal hematologic, coagulation, and blood chemistry assessments [ Time Frame: 15 days after vaccination ]
  6. Percentage of participants achieving antibody responses to specific vaccine components with results ≥ thresholds defined for each vaccine component based on immunoglobulin-binding, opsonophagocytic activity and fibrinogen binding assays. [ Time Frame: 1 month after vaccination ]
    Primary Immunogenicity Endpoints


Secondary Outcome Measures :
  1. Geometric mean titers specific to each vaccine component at each applicable blood sampling time pointe based on immunoglobulin-binding, opsonophagocytic activity and fibrinogen binding assays. [ Time Frame: various, up to 3 months ]
  2. Geometric mean fold rise specific to each vaccine component at each applicable blood sampling time pointe based on immunoglobulin-binding, opsonophagocytic activity and fibrinogen binding assays. [ Time Frame: various, up to 3 months ]
  3. Percentage of participants achieving antibody responses to specific vaccine components with results ≥ thresholds defined for each vaccine component based on immunoglobulin-binding, opsonophagocytic activity and fibrinogen binding assays. [ Time Frame: various, up to 3 months ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492958


Locations
Japan
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, Japan, 130-0004
Medical Co.LTA PS Clinic
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02492958     History of Changes
Other Study ID Numbers: B3451003
6123K1-1006 ( Other Identifier: Alias Study Number )
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs