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Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza; Influenza, Human

Intervention: Fluviral® (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This study is designed to test the safety and immunogenicity of Fluviral (2010 - 2011

Season) in adults aged 18 to 60 years and over 60 years.

Clinical Details

Official title: Immunogenicity and Safety Study of GSK Biologicals' (GSK1536489A) Trivalent Split Virion Influenza Vaccine Fluviral (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years.

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.

Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.

Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.

Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.

Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.

Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.

Secondary outcome:

Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Number of Subjects Reporting Unsolicited Adverse Events (AEs).

Number of Subjects With Serious Adverse Events (SAEs)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the

requirements of the protocol.

- Written informed consent obtained from the subject

- Male and female adults, 18 to 60 years of age and over 60 years of age.

- Satisfactory baseline medical assessment by history and physical examination

- Comprehension of the study requirements, ability to comprehend and comply with

procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the

subject:

- has practiced adequate contraception for 30 days prior to vaccination, and

- has a negative pregnancy test on the day of vaccination, and

- has agreed to continue adequate contraception during the entire treatment period

and for 2 months after completion of the vaccination series. Exclusion Criteria:

- Participation in previous year's (2009) Fluviral registration study

- Administration of any influenza vaccine within 6 months preceding the study start (35

or more subjects in the >60 year old age stratum will be recruited from among those who did NOT receive any inactivated influenza vaccine in 2009-2010 season, i. e. seasonal TIV or pandemic H1N1v).

- Administration of any other vaccine(s) within 30 days prior to study enrollment or

during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.

- Clinically or virologically confirmed influenza infection within 1 year preceding the

study start.

- 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.

- Acute disease at the time of enrollment. (Acute disease is defined as the presence of

a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i. e. oral temperature <38. 0°C.

- Significant acute or chronic, uncontrolled medical or psychiatric illness.

"Uncontrolled" is defined as:

- Requiring institution of new medical or surgical treatment within one (1) month

prior to study enrollment, or

- Requiring the re-institution of a previously discontinued medication or medical

treatment within one month prior to study enrollment, or

- Requiring a change in medication dosage in the one month prior to study

enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or

- Hospitalization or an event fulfilling the definition of a SAE within one month

prior to study enrollment.

- Any confirmed or suspected immunosuppressive condition including:

- History of human immunodeficiency virus (HIV) infection,

- Cancer or treatment for cancer, within 3 years of study enrollment. Persons with

a history of cancer who are disease-free without treatment for 3 years or more are eligible.

- History of renal impairment.

- History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.

- Complicated insulin-dependent diabetes mellitus.

- Unstable cardiopulmonary disease requiring chronic medical therapy or associated with

functional impairment.

- Presence of blood dyscrasias, including hemoglobinopathies and myelo- or

lymphoproliferative disorder.

- Receipt of systemic glucocorticoids (prednisone >= 20 mg/day for more than 14

consecutive days) within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.

- A history of any demyelinating disease including Multiple Sclerosis and

Guillain-Barré syndrome.

- Presence of an active neurological disorder.

- History of chronic alcohol consumption and/or drug abuse.

- 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 (egg protein,

thimerosal) and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury (such as thimerosal).

- 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.

Locations and Contacts

GSK Investigational Site, Sherbrooke, Quebec J1H 1Z1, Canada
Additional Information

Starting date: July 2010
Last updated: October 13, 2011

Page last updated: August 20, 2015

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