Infections, StaphylococcalPhase 1NCT01160172
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults
A Phase 1 study testing Staphylococcal investigational vaccine GSK2392103A, Staphylococcal investigational vaccine GSK2392105A and Staphylococcal investigational vaccine GSK2392106A in people with Infections, Staphylococcal, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Staphylococcal
- What is being tested?
- Staphylococcal investigational vaccine GSK2392103A, Staphylococcal investigational vaccine GSK2392105A and Staphylococcal investigational vaccine GSK2392106A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jul 2010to 23 Aug 2012
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female between 18 and 40 years of age, inclusive, at the time of first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history, clinical examination and laboratory assessment before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
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- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test at Screening, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
Who cannot join
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- Any clinically significant acute or chronic, local or systemic infection, proven or suspected to be caused by Staphylococcus aureus and requiring antibiotic treatment, within the 6 months preceding the first vaccination.
- Previous administration of any investigational Staphylococcus aureus vaccine/antibodies.
- History of; or current bleeding or coagulation disorder.
- Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
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- History of; or current autoimmune or other immune-mediated disease.
- Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines up to 1 month after the last vaccine dose.
- Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Any clinically relevant abnormal haematological or biochemical or urine laboratory values at screening.
- Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
- Acute disease and/or fever at study entry.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of; or current alcoholism and/or drug abuse.
- Any other condition that the principal investigator judges may interfere with study findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Partially Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal 4-component Investigational Vaccine (GSK2392102A) in Healthy Adults
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
- Conditions
- Infections, Staphylococcal
- Being tested
- Staphylococcal investigational vaccine GSK2392103A, Staphylococcal investigational vaccine GSK2392105A, Staphylococcal investigational vaccine GSK2392106A, Staphylococcal investigational vaccine GSK2392019A, Saline placebo
- Keywords
- vaccine, young adults, Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staphylococcal investigational vaccine GSK2392103ABiological
intramuscular vaccination according to protocol schedule
Staphylococcal investigational vaccine GSK2392105ABiological
intramuscular vaccination according to protocol schedule
Staphylococcal investigational vaccine GSK2392106ABiological
intramuscular vaccination according to protocol schedule
Staphylococcal investigational vaccine GSK2392019ABiological
intramuscular vaccination according to protocol schedule
Saline placeboDrug
intramuscular vaccination according to protocol schedule
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Staphylococcal investigational vaccine GSK2392103A |
| Group B | Experimental | Not described Receives: Biological: Staphylococcal investigational vaccine GSK2392105A |
| Group C | Experimental | Not described Receives: Biological: Staphylococcal investigational vaccine GSK2392106A |
| Group D | Experimental | Not described Receives: Biological: Staphylococcal investigational vaccine GSK2392019A |
| Group E | Placebo comparator | Not described Receives: Drug: Saline placebo |
| Group F | Placebo comparator | Not described Receives: Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups.
Measured: During a 7-day (day 0-6) follow up period after each vaccine dose
Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups.
Measured: During a 30-day (day 0-29) follow up period after each vaccine dose
Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups.
Measured: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups.
Measured: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Measured: Prior to each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Measured: 1 day after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Measured: 7 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Measured: 29/30 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Measured: 6 months after the last vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Measured: 12 months after the last vaccine dose
Secondary outcomes (2)
Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups.
Measured: Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose.
Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups.
Measured: At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start19 Jul 2010
- Primary completion23 Aug 2012
- Study completion23 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, StaphylococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160172
- Sponsor's protocol ID
- 113949
- Status last verified
- May 2017
- First submitted
- 1 Jul 2010
- Last updated
- 30 May 2017
- Results posted
- No
Publications
Levy J, Licini L, Haelterman E, Moris P, Lestrate P, Damaso S, Van Belle P, Boutriau D. Safety and immunogenicity of an investigational 4-component Staphylococcus aureus vaccine with or without AS03B adjuvant: Results of a randomized phase I trial. Hum Vaccin Immunother. 2015;11(3):620-31. doi: 10.1080/21645515.2015.1011021.
PubMed 25715157
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal 4-component Investigational Vaccine (GSK2392102A) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01160172
- Acronym / sponsor ID
- 113949
- Conditions
- Infections, Staphylococcal
- Keywords
- vaccine, young adults, Staphylococcus aureus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2010 (actual)
- Primary completion
- 23 Aug 2012 (actual)
- Study completion
- 23 Aug 2012 (actual)
- First posted
- 12 Jul 2010 (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.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Staphylococcal investigational vaccine GSK2392103A |
| Group B | Experimental | Biological: Staphylococcal investigational vaccine GSK2392105A |
| Group C | Experimental | Biological: Staphylococcal investigational vaccine GSK2392106A |
| Group D | Experimental | Biological: Staphylococcal investigational vaccine GSK2392019A |
| Group E | Placebo comparator | Drug: Saline placebo |
| Group F | Placebo comparator | Drug: Saline placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female between 18 and 40 years of age, inclusive, at the time of first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history, clinical examination and laboratory assessment before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
Key exclusion criteria (17 listed)
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- Any clinically significant acute or chronic, local or systemic infection, proven or suspected to be caused by Staphylococcus aureus and requiring antibiotic treatment, within the 6 months preceding the first vaccination.
- Previous administration of any investigational Staphylococcus aureus vaccine/antibodies.
- History of; or current bleeding or coagulation disorder.
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 |
|---|---|---|
| Staphylococcal investigational vaccine GSK2392103Aintramuscular vaccination according to protocol schedule | Biological | Group A |
| Staphylococcal investigational vaccine GSK2392105Aintramuscular vaccination according to protocol schedule | Biological | Group B |
| Staphylococcal investigational vaccine GSK2392106Aintramuscular vaccination according to protocol schedule | Biological | Group C |
| Staphylococcal investigational vaccine GSK2392019Aintramuscular vaccination according to protocol schedule | Biological | Group D |
| Saline placebointramuscular vaccination according to protocol schedule | Drug | Group E, Group F |
Primary outcome
Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups.
Time frame: During a 7-day (day 0-6) follow up period after each vaccine dose
Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups.
Time frame: During a 30-day (day 0-29) follow up period after each vaccine dose
Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups.
Time frame: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups.
Time frame: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: Prior to each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 1 day after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 7 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 29/30 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 6 months after the last vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 12 months after the last vaccine dose
2 secondary outcomes
Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups.
Time frame: Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose.
Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups.
Time frame: At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540.
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 30 May 2017.
- Derived from this study: PubMed 25715157Levy J, Licini L, Haelterman E, Moris P, Lestrate P, Damaso S, Van Belle P, Boutriau D. Safety and immunogenicity of an investigational 4-component Staphylococcus aureus vaccine with or without AS03B adjuvant: Results of a randomized phase I trial. Hum Vaccin Immunother. 2015;11(3):620-31. doi: 10.1080/21645515.2015.1011021.
- Results for study 113949 can be found on the GSK Clinical Study RegisterLink 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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Staphylococcal investigational vaccine GSK2392103A, Staphylococcal investigational vaccine GSK2392105A and Staphylococcal investigational vaccine GSK2392106A in people with Infections, Staphylococcal, run by GlaxoSmithKline at 1 site in Belgium.
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 9 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups. (time frame: During a 7-day (day 0-6) follow up period after each vaccine dose). The study lists 10 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 NCT01160172, which also lists 1 linked publication.
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 30 May 2017.