Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

Condition(s) targeted: Influenza

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

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.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral® (2012/2013 Season) in Adults Aged 18 Years and Older

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

Primary outcome:

Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.

Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.

Secondary outcome:

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

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

Criteria:

Inclusion Criteria:

- Subjects who, in the opinion of the investigator, can and will comply with the

requirements of the protocol.

- A male or female 18 years of age and older at the time of the first vaccination.

- Written informed consent obtained from the subject.

- Healthy subjects as established by medical history and clinical examination before

entering into the study.

- 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. Exclusion Criteria:

- 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.

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

Starting date: July 2012
Last updated: August 8, 2013