A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160172
First received: July 1, 2010
Last updated: July 11, 2013
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.


Condition Intervention Phase
Staphylococcal Vaccines
Biological: Staphylococcal investigational vaccine GSK2392103A
Biological: Staphylococcal investigational vaccine GSK2392105A
Biological: Staphylococcal investigational vaccine GSK2392106A
Biological: Staphylococcal investigational vaccine GSK2392019A
Drug: Saline placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: Prior to each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 1 day after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 7 days after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 29/30 days after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 6 months after the last vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 12 months after the last vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Biological: Staphylococcal investigational vaccine GSK2392103A
intramuscular vaccination according to protocol schedule
Experimental: Group B
Not Applicable
Biological: Staphylococcal investigational vaccine GSK2392105A
intramuscular vaccination according to protocol schedule
Experimental: Group C
Not Applicable
Biological: Staphylococcal investigational vaccine GSK2392106A
intramuscular vaccination according to protocol schedule
Experimental: Group D
Not Applicable
Biological: Staphylococcal investigational vaccine GSK2392019A
intramuscular vaccination according to protocol schedule
Placebo Comparator: Group E
Not Applicable
Drug: Saline placebo
intramuscular vaccination according to protocol schedule
Placebo Comparator: Group F
Not Applicable
Drug: Saline placebo
intramuscular vaccination according to protocol schedule

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160172

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01160172     History of Changes
Other Study ID Numbers: 113949
Study First Received: July 1, 2010
Last Updated: July 11, 2013
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
vaccine
young adults
Staphylococcus aureus

ClinicalTrials.gov processed this record on April 17, 2014