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

Primary Purpose

Infections, Staphylococcal

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Staphylococcal investigational vaccine GSK2392103A
Staphylococcal investigational vaccine GSK2392105A
Staphylococcal investigational vaccine GSK2392106A
Staphylococcal investigational vaccine GSK2392019A
Saline placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Staphylococcal focused on measuring vaccine, young adults, Staphylococcus aureus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups.
Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups.
Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups.
Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups.
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.

Secondary Outcome Measures

Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups.
Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups.

Full Information

First Posted
July 1, 2010
Last Updated
May 24, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01160172
Brief Title
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 19, 2010 (Actual)
Primary Completion Date
August 23, 2012 (Actual)
Study Completion Date
August 23, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Staphylococcal
Keywords
vaccine, young adults, Staphylococcus aureus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Arm Title
Group D
Arm Type
Experimental
Arm Title
Group E
Arm Type
Placebo Comparator
Arm Title
Group F
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Staphylococcal investigational vaccine GSK2392103A
Intervention Description
intramuscular vaccination according to protocol schedule
Intervention Type
Biological
Intervention Name(s)
Staphylococcal investigational vaccine GSK2392105A
Intervention Description
intramuscular vaccination according to protocol schedule
Intervention Type
Biological
Intervention Name(s)
Staphylococcal investigational vaccine GSK2392106A
Intervention Description
intramuscular vaccination according to protocol schedule
Intervention Type
Biological
Intervention Name(s)
Staphylococcal investigational vaccine GSK2392019A
Intervention Description
intramuscular vaccination according to protocol schedule
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Intervention Description
intramuscular vaccination according to protocol schedule
Primary Outcome Measure Information:
Title
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
Title
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
Title
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)
Title
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)
Title
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time Frame
Prior to each vaccine dose
Title
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time Frame
1 day after each vaccine dose
Title
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time Frame
7 days after each vaccine dose
Title
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time Frame
29/30 days after each vaccine dose
Title
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time Frame
6 months after the last vaccine dose
Title
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time Frame
12 months after the last vaccine dose
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
25715157
Citation
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.
Results Reference
derived

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

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