Staphylococcal InfectionsPhase 1NCT01643941
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 study testing SA4Ag vaccine low dose, Blood draw and Colonization swab sample in people with Staphylococcal Infections, run by Pfizer at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- SA4Ag vaccine low dose, Blood draw and Colonization swab sample
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2012to Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Benchmark Research
Austin, Texas, 78705
PMG Research of Raleigh, LLC
Cary, North Carolina, 27518
Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
Cincinnati, Ohio, 45206
Broward Research Group
Hollywood, Florida, 33024
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Miami Research Associates
South Miami, Florida, 33143
About this study
Official title: 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
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.
- Conditions
- Staphylococcal Infections
- Being tested
- SA4Ag vaccine low dose, Blood draw, Colonization swab sample, SA4Ag vaccine mid dose, SA4Ag vaccine high dose
- Keywords
- Staphylococcus aureus, vaccine, Staphylococcal infection
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA4Ag vaccine low doseBiological
Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
Blood drawProcedure or surgery
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various timepoints.
SA4Ag vaccine mid doseBiological
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Blood drawProcedure or surgery
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various timepoints.
SA4Ag vaccine high doseBiological
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
Blood drawProcedure or surgery
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various timepoints.
SA3Ag vaccineBiological
Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.
Blood sampleProcedure or surgery
Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various timepoints.
PlaceboBiological
Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.
Blood drawProcedure or surgery
Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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.
Colonization swab samplesProcedure or surgery
Colonization swabs will be collected from all subjects at various timepoints.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SA4Ag vaccine low dose Receives: Biological: SA4Ag vaccine low dose; Procedure: Blood draw; Procedure: Colonization swab sample |
| 2 | Experimental | SA4Ag vaccine mid dose Receives: Biological: SA4Ag vaccine mid dose; Procedure: Blood draw; Procedure: Colonization swab sample |
| 3 | Experimental | SA4Ag vaccine high dose Receives: Biological: SA4Ag vaccine high dose; Procedure: Blood draw; Procedure: Colonization swab sample |
| 4 | Experimental | SA3Ag vaccine Receives: Biological: SA3Ag vaccine; Procedure: Blood sample; Procedure: Colonization swab sample |
| 5 | Placebo comparator | Placebo Receives: Biological: Placebo; Procedure: Blood draw; Procedure: Colonization swab samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of subjects reporting solicited local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries)
Measured: 14 days
Number and proportion of subjects reporting solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain) and severity of solicited systemic events self-reported on electronic diaries
Measured: 14 days
Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: 1 month (AEs); 6 months (SAEs)
Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments
Measured: 14 days
Number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments
Measured: 14 days
Proportion of subjects achieving antibody responses to specific vaccine components with results ≥ thresholds defined for each vaccine component based on immunoglobulin-binding and/or opsonphagocytic activity assays
Measured: 1 month
Secondary outcomes (7)
Immunoglobulin titers measured as geometric mean titers for each antigen at each applicable blood sampling time point, as measured by antigen-specific antibody levels using an immunoglobulin binding assay.
Measured: various, up to 12 months
Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates at each applicable blood sampling time point.
Measured: various, up to 12 months
Immunoglobulin geometric mean fold rise for each of the vaccine components as measured by antigen-specific antibody levels using an immunoglobulin binding assay.
Measured: 1 month
Geometric mean fold rise on opsonophagocytic activity assay titers against S. aureus isolates.
Measured: 1 month
Proportion of subjects achieving antibody responses to specific antigens with results ≥ thresholds defined for each vaccine component at each applicable visit.
Measured: Various, up to 12 months
Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in immunoglobulin titers from baseline to each applicable visit after vaccination for each antigen.
Measured: Various, up to 12 months
Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in opsonophagocytic activity titers against S. aureus isolates from baseline to each applicable visit after vaccination.
Measured: Various, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643941
- Sponsor's protocol ID
- B3451011
- Status last verified
- Feb 2019
- First submitted
- 9 Jul 2012
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Creech CB, Frenck RW, Fiquet A, Feldman R, Kankam MK, Pathirana S, Baber J, Radley D, Cooper D, Eiden J, Gruber WC, Jansen KU, Anderson AS, Gurtman A. Persistence of Immune Responses Through 36 Months in Healthy Adults After Vaccination With a Novel Staphylococcus aureus 4-Antigen Vaccine (SA4Ag). Open Forum Infect Dis. 2019 Dec 24;7(1):ofz532. doi: 10.1093/ofid/ofz532. eCollection 2020 Jan.
PubMed 31993453Creech CB, Frenck RW Jr, Sheldon EA, Seiden DJ, Kankam MK, Zito ET, Girgenti D, Severs JM, Immermann FW, McNeil LK, Cooper D, Jansen KU, Gruber W, Eiden J, Anderson AS, Baber J. Safety, tolerability, and immunogenicity of a single dose 4-antigen or 3-antigen Staphylococcus aureus vaccine in healthy older adults: Results of a randomised trial. Vaccine. 2017 Jan 5;35(2):385-394. doi: 10.1016/j.vaccine.2016.11.032. Epub 2016 Nov 17.
PubMed 27866765
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01643941
- Acronym / sponsor ID
- B3451011
- Conditions
- Staphylococcal Infections
- Keywords
- Staphylococcus aureus, vaccine, Staphylococcal infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: SA4Ag vaccine low dose, Procedure: Blood draw, Procedure: Colonization swab sampleSA4Ag vaccine low dose |
| 2 | Experimental | Biological: SA4Ag vaccine mid dose, Procedure: Blood draw, Procedure: Colonization swab sampleSA4Ag vaccine mid dose |
| 3 | Experimental | Biological: SA4Ag vaccine high dose, Procedure: Blood draw, Procedure: Colonization swab sampleSA4Ag vaccine high dose |
| 4 | Experimental | Biological: SA3Ag vaccine, Procedure: Blood sample, Procedure: Colonization swab sampleSA3Ag vaccine |
| 5 | Placebo comparator | Biological: Placebo, Procedure: Blood draw, Procedure: Colonization swab samplesPlacebo |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SA4Ag vaccine low doseSubjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine. | Biological | 1 |
| Blood drawBlood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 or surgery | 1 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various timepoints. | Procedure or surgery | 1 |
| SA4Ag vaccine mid doseSubjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine. | Biological | 2 |
| Blood drawBlood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 or surgery | 2 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various timepoints. | Procedure or surgery | 2 |
| SA4Ag vaccine high doseSubjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine. | Biological | 3 |
| Blood drawBlood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 or surgery | 3 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various timepoints. | Procedure or surgery | 3 |
| SA3Ag vaccinePhase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine. | Biological | 4 |
| Blood sampleBlood for immunogenicity will be collected from all subjects at various timepoints. | Procedure or surgery | 4 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various timepoints. | Procedure or surgery | 4 |
| PlaceboSubjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients. | Biological | 5 |
| Blood drawBlood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. 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 or surgery | 5 |
| Colonization swab samplesColonization swabs will be collected from all subjects at various timepoints. | Procedure or surgery | 5 |
Primary outcome
Number and proportion of subjects reporting solicited local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries)
Time frame: 14 days
Number and proportion of subjects reporting solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain) and severity of solicited systemic events self-reported on electronic diaries
Time frame: 14 days
Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: 1 month (AEs); 6 months (SAEs)
Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments
Time frame: 14 days
Number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments
Time frame: 14 days
Proportion of subjects achieving antibody responses to specific vaccine components with results ≥ thresholds defined for each vaccine component based on immunoglobulin-binding and/or opsonphagocytic activity assays
Time frame: 1 month
7 secondary outcomes
Immunoglobulin titers measured as geometric mean titers for each antigen at each applicable blood sampling time point, as measured by antigen-specific antibody levels using an immunoglobulin binding assay.
Time frame: various, up to 12 months
Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates at each applicable blood sampling time point.
Time frame: various, up to 12 months
Immunoglobulin geometric mean fold rise for each of the vaccine components as measured by antigen-specific antibody levels using an immunoglobulin binding assay.
Time frame: 1 month
Geometric mean fold rise on opsonophagocytic activity assay titers against S. aureus isolates.
Time frame: 1 month
Proportion of subjects achieving antibody responses to specific antigens with results ≥ thresholds defined for each vaccine component at each applicable visit.
Time frame: Various, up to 12 months
Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in immunoglobulin titers from baseline to each applicable visit after vaccination for each antigen.
Time frame: Various, up to 12 months
Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in opsonophagocytic activity titers against S. aureus isolates from baseline to each applicable visit after vaccination.
Time frame: Various, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Derived from this study: PubMed 31993453Creech CB, Frenck RW, Fiquet A, Feldman R, Kankam MK, Pathirana S, Baber J, Radley D, Cooper D, Eiden J, Gruber WC, Jansen KU, Anderson AS, Gurtman A. Persistence of Immune Responses Through 36 Months in Healthy Adults After Vaccination With a Novel Staphylococcus aureus 4-Antigen Vaccine (SA4Ag). Open Forum Infect Dis. 2019 Dec 24;7(1):ofz532. doi: 10.1093/ofid/ofz532. eCollection 2020 Jan.
- Derived from this study: PubMed 27866765Creech CB, Frenck RW Jr, Sheldon EA, Seiden DJ, Kankam MK, Zito ET, Girgenti D, Severs JM, Immermann FW, McNeil LK, Cooper D, Jansen KU, Gruber W, Eiden J, Anderson AS, Baber J. Safety, tolerability, and immunogenicity of a single dose 4-antigen or 3-antigen Staphylococcus aureus vaccine in healthy older adults: Results of a randomised trial. Vaccine. 2017 Jan 5;35(2):385-394. doi: 10.1016/j.vaccine.2016.11.032. Epub 2016 Nov 17.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SA4Ag vaccine low dose, Blood draw and Colonization swab sample in people with Staphylococcal Infections, run by Pfizer at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of subjects reporting solicited local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries) (time frame: 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643941, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.