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COMPLETEDPHASE1

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

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

NCT01643941•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.
+7 more criteria

Locations (7)

Broward Research Group

Hollywood, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

PMG Research of Raleigh, LLC

Cary, North Carolina, United States

Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Benchmark Research

Austin, Texas, United States

Key Dates

Start Date

August 1, 2012

Primary Completion Date

May 1, 2013

Completion Date

March 1, 2014

Last Updated

March 4, 2019

Enrollment

284

ACTUAL participants

Conditions

Staphylococcal Infections

Interventions

SA4Ag vaccine low dose

BIOLOGICAL

Blood draw

PROCEDURE

Colonization swab sample

PROCEDURE

SA4Ag vaccine mid dose

BIOLOGICAL

Blood draw

PROCEDURE

Colonization swab sample

PROCEDURE

SA4Ag vaccine high dose

BIOLOGICAL

Blood draw

PROCEDURE

Colonization swab sample

PROCEDURE

SA3Ag vaccine

BIOLOGICAL

Blood sample

PROCEDURE

Colonization swab sample

PROCEDURE

Placebo

BIOLOGICAL

Blood draw

PROCEDURE

Colonization swab samples

PROCEDURE

Unbound Cloxacillin Concentrations During Continuous Infusion

NCT06848387

Staphylococcal Infections

View study

RECRUITINGPHASE4

Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

NCT05899140

Skin InfectionStaphylococcal Infections+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Unbound Cloxacillin Concentrations During Continuous Infusion

Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

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