Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years

NCT01364571

Last updated date
Study Location
Broward Research Group
Hollywood, Florida, 33024, United States
Contact
1-800-718-1021

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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
18-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy adults aged 18 to <65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.

- Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (e-diary) from Day 1 to Day 14 following vaccination(s).

- Ability to be contacted by telephone during study participation.

- All male and female subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study.

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


- Unstable chronic medical condition or disease requiring significant change in therapy
or hospitalization within 3 months before receipt of study vaccine.


- Serious chronic medical disorders and any other disorder that in the investigator's
opinion precludes the subject from participating in the study


- Donation of blood volume of 250 mL or greater (excluding protocol-required blood
collection), or donation of plasma within 3 months prior to enrollment.


- Bleeding condition associated with prolonged bleeding time that may contraindicate
intramuscular injection or blood draw including subjects taking anticoagulant,
antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30
days before enrollment through 1 month post-vaccination.


- Any contraindication to vaccination or vaccine components.


- Immunocompromised persons and subjects currently on immunosuppressive therapy or with
a history of immunosuppressive therapy, including chemotherapy agents or long term
systemic corticosteroids.


- Previous administration of S. aureus vaccination.


- Any infection proven or suspected to be caused by S. aureus within 6 months preceding
study vaccination.


- Receipt of blood products or immunoglobulins (including monoclonal antibodies) within
12 months before enrollment through conclusion of the study.


- Participation in other investigational or interventional studies within 30 days before
the current study begins and/or during study participation.


- Subjects who are investigational site staff members or subjects who are immediate
family members (1st degree relatives) of investigational site staff members or Pfizer
employees directly involved in the conduct of the trial.


- Residence in a nursing home or long-term care facility or requirement for semiskilled
nursing care.


- For Phase 1 subjects only, any abnormality in screening hematology, coagulation and/or
blood chemistry laboratory values.


- Women who are pregnant (as determined by urine pregnancy test) or breastfeeding.


- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
Official Title  ICMJE A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years
Brief Summary This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to <65 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Staphylococcal Infections
Intervention  ICMJE
  • Biological: SA4Ag vaccine low dose
    Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
  • Procedure: Blood draw
    Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
  • Procedure: Colonization swab sample
    Colonization swabs will be collected from all subjects at various time points throughout the study.
  • Biological: SA4Ag vaccine mid dose
    Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
  • Procedure: Blood sample
    Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
  • Biological: SA4Ag vaccine high dose
    Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
  • Biological: Placebo
    Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
Study Arms  ICMJE
  • Experimental: 1
    SA4Ag vaccine low dose
    Interventions:
    • Biological: SA4Ag vaccine low dose
    • Procedure: Blood draw
    • Procedure: Colonization swab sample
  • Experimental: 2
    SA4Ag vaccine mid dose
    Interventions:
    • Biological: SA4Ag vaccine mid dose
    • Procedure: Blood sample
    • Procedure: Colonization swab sample
  • Experimental: 3
    SA4Ag vaccine high dose
    Interventions:
    • Biological: SA4Ag vaccine high dose
    • Procedure: Blood draw
    • Procedure: Colonization swab sample
  • Placebo Comparator: 4
    Placebo
    Interventions:
    • Biological: Placebo
    • Procedure: Blood draw
    • Procedure: Colonization swab sample
Publications *

*   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: August 4, 2011)
456
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
1068
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults aged 18 to <65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
  • Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (e-diary) from Day 1 to Day 14 following vaccination(s).
  • Ability to be contacted by telephone during study participation.
  • All male and female subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study.

Exclusion Criteria:

  • Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization within 3 months before receipt of study vaccine.
  • Serious chronic medical disorders and any other disorder that in the investigator's opinion precludes the subject from participating in the study
  • Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection), or donation of plasma within 3 months prior to enrollment.
  • Bleeding condition associated with prolonged bleeding time that may contraindicate intramuscular injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30 days before enrollment through 1 month post-vaccination.
  • Any contraindication to vaccination or vaccine components.
  • Immunocompromised persons and subjects currently on immunosuppressive therapy or with a history of immunosuppressive therapy, including chemotherapy agents or long term systemic corticosteroids.
  • Previous administration of S. aureus vaccination.
  • Any infection proven or suspected to be caused by S. aureus within 6 months preceding study vaccination.
  • Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 12 months before enrollment through conclusion of the study.
  • Participation in other investigational or interventional studies within 30 days before the current study begins and/or during study participation.
  • Subjects who are investigational site staff members or subjects who are immediate family members (1st degree relatives) of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.
  • Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care.
  • For Phase 1 subjects only, any abnormality in screening hematology, coagulation and/or blood chemistry laboratory values.
  • Women who are pregnant (as determined by urine pregnancy test) or breastfeeding.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01364571
Other Study ID Numbers  ICMJE B3451001
6123K1-1005 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP