Last updated: 11/07/2018 07:03:36
A study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ Staphylococcal investigational vaccine in healthy adults
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: Prior to each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Timeframe: 1 day after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Timeframe: 7 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Timeframe: 29/30 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Timeframe: 6 months after the last vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Timeframe: 12 months after the last vaccine dose
Secondary outcomes:
Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups.
Timeframe: 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.
Timeframe: At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540.
Interventions:
Biological/vaccine: Staphylococcal investigational vaccine GSK2392103A
Biological/vaccine: Staphylococcal investigational vaccine GSK2392105A
Biological/vaccine: Staphylococcal investigational vaccine GSK2392106A
Biological/vaccine: Staphylococcal investigational vaccine GSK2392019A
Drug: Saline placebo
Enrollment:
88
Observational study model:
Not applicable
Primary completion date:
2012-23-08
Time perspective:
Not applicable
Clinical publications:
Levy J et al. (2015) 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. 11(3):620-631.
Medical condition
Infections, Staphylococcal
Product
GSK2392102A, GSK2392103A, GSK2392105A, GSK2392106A, GSK2392109A
Collaborators
Not applicable
Study date(s)
July 2010 to August 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- * 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.
- * 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.
Inclusion and exclusion criteria
Inclusion criteria:
- * 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:
- 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
Exclusion criteria:
- * 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. * 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 location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2012-23-08
Actual study completion date
2012-23-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 113949 can be found on the GSK Clinical Study Register
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