Last updated: 11/03/2018 09:22:53

Study to Evaluate an Influenza Vaccine Candidate

GSK study ID
107022
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: A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
Trial description: The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
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 virus

Timeframe: At Days 0 and 21 post-vaccination

Secondary outcomes:

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

Timeframe: At Day 180 post-vaccination.

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

Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination

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

Timeframe: During the 7-day (Days 0-6) follow up period after vaccination

Number of subjects with unsolicited adverse events (AEs).

Timeframe: During the 30-day (Days 0-29) follow-up period after vaccination

Number of subjects with any and related serious adverse events (SAEs)

Timeframe: During the entire study period (Day 0 to Day 180)

Interventions:
Biological/vaccine: Candidate Influenza Vaccine GSK1247446A – 2 different formulations
Biological/vaccine: FluarixTM
Enrollment:
1220
Observational study model:
Not applicable
Primary completion date:
2006-18-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1247446A
Collaborators
Not applicable
Study date(s)
May 2006 to July 2006
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
  • A male or female age 60 years or older at the time of the vaccination.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Turku, Finland, 20520
Status
Study Complete
Location
GSK Investigational Site
Kotka, Finland, 48100
Status
Study Complete
Location
GSK Investigational Site
Haidari, Greece, 124 62
Status
Study Complete
Location
GSK Investigational Site
Goudi / Athens, Greece, 115 27
Status
Study Complete
Location
GSK Investigational Site
Nikaia Piraeus, Greece, 184 54
Status
Study Complete
Location
GSK Investigational Site
Lahti, Finland, 15140
Status
Study Complete
Location
GSK Investigational Site
Jarvenpaa, Finland, 04400
Status
Study Complete
Location
GSK Investigational Site
Oulu, Finland, 90100
Status
Study Complete
Location
GSK Investigational Site
Marousi, Greece, 151 26
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00100
Status
Study Complete
Location
GSK Investigational Site
Vantaa, Finland, 01300
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00930
Status
Study Complete
Location
GSK Investigational Site
Thessaloniki, Greece, 54642
Status
Study Complete
Location
GSK Investigational Site
Tampere, Finland, 33200
Status
Study Complete
Location
GSK Investigational Site
Vantaa, Finland, 01600
Status
Study Complete
Location
GSK Investigational Site
Orestiada, Greece, 682 00
Status
Study Complete
Location
GSK Investigational Site
Pori, Finland, 28120
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
2006-18-07
Actual study completion date
2006-18-07

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
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