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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014