Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years
NCT01643941
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- Healthy males and healthy postmenopausal females, aged 65 to <86 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.
- Available for the entire duration of the study, and able to comply with scheduled visits, study plan, laboratory tests, and other study procedures including completion of the electronic diary (e diary) from Day 1 to Day 14 following vaccination.
- Able to be contacted by telephone during study participation.
- Male subjects who, in the opinion of the investigator, are biologically capable of fathering children, and who are sexually active with women of childbearing potential must agree to use a highly effective method of contraception throughout the study.
- Unstable chronic medical condition or disease requiring significant change in therapy
or hospitalization for worsening disease within 3 months before receipt of study
vaccine.
- Serious chronic medical disorders or any disorder that in the investigator's opinion
precludes the subject from participating in the study.
- Donation of blood volume of 250 mL or greater or donation of plasma within 3 months
prior to enrollment through conclusion of the study.
- 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 completion of Visit 6 (Day 29).
- Any contraindication to vaccination or vaccine components, including previous
anaphylactic reaction to any vaccine or vaccine related components.
- Immunocompromised persons or subjects currently on immunosuppressive therapy or with a
history of immunosuppressive therapy. History of immune-modifying drugs.
- 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. Participation in purely
observational studies is acceptable.
- Subjects who are investigational site staff members or subjects who are immediate
family members (first-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. An ambulatory subject who is a resident of a retirement home or village
is eligible for the trial.
- A Mini-Mental State Examination (MMSE) score of ≤21.
- For Phase 1 subjects only, any abnormality in screening hematology, coagulation,
and/or blood chemistry laboratory values except as noted in protocol
- Subjects with known active disease with human immunodeficiency virus (HIV), hepatitis
B virus (HBV), and/or hepatitis C virus (HCV), or Phase 1 subjects with a positive
screening test for HIV, HBV and/or HCV.
- 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.
- Planned surgical procedure within 30 days following vaccination.
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Descriptive Information | ||||
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Brief Title ICMJE | Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 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) And A Single Dose Level Of A 3-antigen Staphylococcus Aureus Vaccine (sa3ag) In Healthy Adults Aged 65 To <86 Years | |||
Brief Summary | This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). 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 65 to <86 years. In addition, the study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to <86 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 |
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Study Arms ICMJE |
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Publications * |
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* 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 | 284 | |||
Original Estimated Enrollment ICMJE | 273 | |||
Actual Study Completion Date ICMJE | March 2014 | |||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years to 85 Years (Older 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 | NCT01643941 | |||
Other Study ID Numbers ICMJE | B3451011 | |||
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 |
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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 |