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SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

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NCT02492958

Last updated on November 13, 2019
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FOR MORE INFORMATION
Study Location
SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
Sumida-ku, Tokyo, 130-0004 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Staphylococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Japanese male and female adults aged 20 to

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT02492958
Pfizer
Completed
SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

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Descriptive Information
Brief Title  ICMJE SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Staphylococcal Infections
Intervention  ICMJE
  • 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
  • Biological: Placebo
    a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
Study Arms  ICMJE
  • Experimental: SA4Ag
    Staphylococcus aureus 4-antigen vaccine
    Intervention: Biological: Staphylococcus aureus 4-antigen vaccine
  • Placebo Comparator: Placebo
    a lyophile match to the vaccine, consisting of excipients of SA4Ag formulation minus the active ingredients
    Intervention: Biological: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2015)		136
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion DateSeptember 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02492958
Other Study ID Numbers  ICMJE B3451003
6123K1-1006 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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