Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults
This study has been completed.
Information provided by (Responsible Party):
First received: June 21, 2012
Last updated: August 23, 2012
Last verified: August 2012
This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral® (2012/2013 Season) in Adults Aged 18 Years and Older
Primary Outcome Measures:
- Humoral immune response in terms of HI antibodies against each of the 3 vaccine influenza strains in subjects 18 years of age and above. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- Humoral immune response in terms of HI antibodies against each of the 3 vaccine influenza strains in subjects aged 18 years of age and above. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of solicited local and general adverse events (AEs). [ Time Frame: During a 4-day (Day 0 to 3) follow-up period after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited AEs. [ Time Frame: Within 21 days after vaccination (Day 0 - Day 20) ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events (SAEs). [ Time Frame: From the beginning (Day 0) up to the study end (Day 21) ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
Experimental: Group FLU Q-TIV
Subjects 18 years and older will receive Fluviral®
1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
- Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
- Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- Acute disease and/or fever at the time of enrolment.
- Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness.
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Insulin-dependent diabetes mellitus.
- Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
- History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- Any known or suspected allergy to any constituent of Fluviral® and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
- A history of severe adverse reaction to a previous influenza vaccination.
- Pregnant and/or lactating/nursing female.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626820
|GSK Investigational Site
|Sherbrooke, Quebec, Canada, J1H 1Z1 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 21, 2012
||August 23, 2012
||Canada: Biologics and Genetic Therapies Directorate (BGTD)
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases