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SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

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NCT02492958

Last updated on March 25, 2018
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FOR MORE INFORMATION
Study Location
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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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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Staphylococcal Infections
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
September 2016
September 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02492958
B3451003
6123K1-1006 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2016

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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