Last updated: 02/13/2019 07:42:04

Study to Evaluate an Influenza Vaccine Candidate

GSK study ID
110794
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunogenicity, safety and reactogenicity of GSK Biologicals' influenza vaccine GSK1247446A with various formulations in subjects aged 18-64 years
Trial description: In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.

Timeframe: At Days 0, 21 and 180

Secondary outcomes:

Number of seroconverted subjects against 3 strains of influenza disease.

Timeframe: At Days 21 and 180

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.

Timeframe: At Days 21 and 180

Number of seroprotected subjects against 3 strains of influenza disease.

Timeframe: At Days 0, 21 and 180

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Timeframe: At Days 0 and 21

Geometric mean of influenza-specific Cluster of Differentiation (CD) 4 T-cells.

Timeframe: At Days 0, 21 and 180

Geometric mean of influenza-specific Cluster of Differentiation (CD) 8 T-cells.

Timeframe: At Days 0, 21 and 180

Number of subjects with any and grade 3 solicited local symptoms.

Timeframe: During the 7-day (Days 0-6) post vaccination period

Number of subjects with any, grade 3 and related solicited general symptoms.

Timeframe: During the 7-day (Days 0-6) post vaccination period

Number of subjects with any, grade 3 and related medically significant conditions (MSCs).

Timeframe: From Day 0 to Day 180

Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).

Timeframe: During the 21-day (Days 0-20) post vaccination period

Number of subjects with serious adverse events (SAEs).

Timeframe: From Day 0 to Day 180

Interventions:
Biological/vaccine: Influenza Vaccine GSK1247446A – 4 different formulations
Biological/vaccine: Fluarix™
Enrollment:
1006
Observational study model:
Not applicable
Primary completion date:
2008-08-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1247446A
Collaborators
Not applicable
Study date(s)
October 2007 to May 2008
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
  • Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
  • A male or female between, and including, 18 - 64 years of age at the time of vaccination.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Study Complete
Location
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
Status
Study Complete
Location
GSK Investigational Site
Lille, France, 59019
Status
Study Complete
Location
GSK Investigational Site
Caen cedex 4, France, 14052
Status
Study Complete
Location
GSK Investigational Site
Lagord, France, 17140
Status
Study Complete
Location
GSK Investigational Site
Toulouse, France, 31300
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08036
Status
Study Complete
Location
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
Status
Study Complete
Location
GSK Investigational Site
Paris Cedex 18, France, 75877
Status
Study Complete
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28040
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Study Complete
Location
GSK Investigational Site
Paris, France, 75679
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28035
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2008-08-05
Actual study completion date
2008-08-05

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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