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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2006-07-07
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
Completed
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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