Last updated: 11/03/2018 09:33:12

Study to demonstrate the lot-to-lot consistency and to evaluate the safety of an adjuvanted influenza vaccine candidate

GSK study ID
107192
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Demonstrate the lot-to-lot consistency of 3 consecutive production lots of an adjuvanted influenza vaccine candidate and evaluate the safety of an adjuvanted influenza vaccine candidate versus Fluarix™ administered intramuscularly in elderly
Trial description: The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: At Days 0 and 21

Number of seroconverted subjects against 3 strains of influenza disease.

Timeframe: At Day 21

Number of seroprotected subjects against 3 strains of influenza disease.

Timeframe: At Days 0 and 21

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

Timeframe: At Day 21

Number of subjects with any, grade 3 and related 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 new onset of chronic diseases (NOCDs).

Timeframe: From Day 0 to Day 180

Number of subjects with 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 30-day (Days 0-29) post-vaccination period

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

Timeframe: During the entire study period (Days 0-180)

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Candidate Influenza Vaccine GSK1247446A – 3 different formulations
  • Biological/vaccine: Fluarix TM
  • Enrollment:
    3124
    Primary completion date:
    2006-07-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK1247446A
    Collaborators
    Not applicable
    Study date(s)
    April 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
    Rouen, France, 76100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Weissenberg, Sachsen, Germany, 02627
    Status
    Study Complete
    Location
    GSK Investigational Site
    Haidari, Greece, 124 62
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris, France, 75679
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ketzin, Brandenburg, Germany, 14669
    Status
    Study Complete
    Location
    GSK Investigational Site
    Reading, Berkshire, United Kingdom, RG2 7AG
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ekaterinburg, Russia, 620078
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saratov, Russia, 410018
    Status
    Study Complete
    Location
    GSK Investigational Site
    Marousi, Greece, 151 26
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tartu, Estonia, 50417
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gières, France, 38610
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamar, Norway, 2317
    Status
    Study Complete
    Location
    GSK Investigational Site
    Edgbaston, Birmingham, United Kingdom, B15 2SQ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wolmirstedt, Sachsen-Anhalt, Germany, 39326
    Status
    Study Complete
    Location
    GSK Investigational Site
    Poitiers, France, 86000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cardiff, Glamorgan, United Kingdom, CF14 5GJ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Montpellier Cedex 5, France, 34295
    Status
    Study Complete
    Location
    GSK Investigational Site
    Delitzsch, Sachsen, Germany, 04509
    Status
    Study Complete
    Location
    GSK Investigational Site
    Stavanger, Norway, 4010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pirna, Sachsen, Germany, 01796
    Status
    Study Complete
    Location
    GSK Investigational Site
    Caen cedex 4, France, 14052
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kazan, Russia, 420015
    Status
    Study Complete
    Location
    GSK Investigational Site
    Waterloo, Liverpool, United Kingdom, L22 0LG
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lagord, France, 17140
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lille, France, 59019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Koenigslutter, Niedersachsen, Germany, 38154
    Status
    Study Complete
    Location
    GSK Investigational Site
    Marktl, Bayern, Germany, 84533
    Status
    Study Complete
    Location
    GSK Investigational Site
    Haag, Bayern, Germany, 83527
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tostedt, Niedersachsen, Germany, 21255
    Status
    Study Complete
    Location
    GSK Investigational Site
    Orestiada, Greece, 682 00
    Status
    Study Complete
    Location
    GSK Investigational Site
    Glasgow, Lanarkshire, United Kingdom, G81 4SA
    Status
    Study Complete
    Location
    GSK Investigational Site
    Goudi / Athens, Greece, 115 27
    Status
    Study Complete
    Location
    GSK Investigational Site
    Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oberaudorf, Bayern, Germany, 83080
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kamenz, Sachsen, Germany, 01917
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 11527
    Status
    Study Complete
    Location
    GSK Investigational Site
    Elverum, Norway, 2408
    Status
    Study Complete
    Location
    GSK Investigational Site
    Papagos/Athens, Greece, 15669
    Status
    Study Complete
    Location
    GSK Investigational Site
    Freital, Sachsen, Germany, 01705
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nikaia Piraeus, Greece, 184 54
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 54642
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bad Bramstedt, Schleswig-Holstein, Germany, 24576
    Status
    Study Complete
    Location
    GSK Investigational Site
    Manchester, United Kingdom, M15 6SX
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paradis, Norway, 5231
    Status
    Study Complete
    Location
    GSK Investigational Site
    Toulouse, France, 31300
    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
    Study complete
    Actual primary completion date
    2006-07-07
    Actual study completion date
    2006-07-07

    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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