Study to Evaluate an Influenza Vaccine Candidate
A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
2 other identifiers
interventional
1,220
2 countries
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedStudy Start
First participant enrolled
May 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2006
CompletedResults Posted
Study results publicly available
May 1, 2013
CompletedJune 8, 2018
September 1, 2016
2 months
March 16, 2006
March 14, 2013
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.
At Days 0 and 21 post-vaccination
Secondary Outcomes (5)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
At Day 180 post-vaccination.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
During the 7-day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
During the 7-day (Days 0-6) follow up period after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs).
During the 30-day (Days 0-29) follow-up period after vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
During the entire study period (Day 0 to Day 180)
Study Arms (3)
GSK1247446A-AS03 Group
EXPERIMENTALSubjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Group
EXPERIMENTALSubjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group
ACTIVE COMPARATORSubjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Interventions
Single dose, Intramuscular injection
Eligibility Criteria
You may qualify if:
- 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
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
You may not qualify if:
- 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.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
- History of hypersensivity to a previous dose of influenza vaccine.
- Previous vaccination against influenza within the 9 months prior to enrollment.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (17)
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00930, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Kotka, 48100, Finland
GSK Investigational Site
Lahti, 15140, Finland
GSK Investigational Site
Oulu, 90100, Finland
GSK Investigational Site
Pori, 28120, Finland
GSK Investigational Site
Tampere, 33200, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Vantaa, 01300, Finland
GSK Investigational Site
Vantaa, 01600, Finland
GSK Investigational Site
Goudi / Athens, 115 27, Greece
GSK Investigational Site
Haidari, 124 62, Greece
GSK Investigational Site
Marousi, 151 26, Greece
GSK Investigational Site
Nikaia Piraeus, 184 54, Greece
GSK Investigational Site
Orestiáda, 682 00, Greece
GSK Investigational Site
Thessaloniki, 54642, Greece
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2006
First Posted
May 3, 2006
Study Start
May 11, 2006
Primary Completion
July 1, 2006
Study Completion
July 18, 2006
Last Updated
June 8, 2018
Results First Posted
May 1, 2013
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.