A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

NCT ID: NCT00866580

Last Updated: 2015-03-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-07-31

Brief Summary

This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A

Group Type: EXPERIMENTAL

GSK's candidate influenza vaccine 1562902A

Intervention Type: BIOLOGICAL

Intramuscular dose on Day 0 and Day 21

FluarixTM

Intervention Type: BIOLOGICAL

Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

Placebo

Intervention Type: BIOLOGICAL

Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

Group B

Group Type: EXPERIMENTAL

GSK's candidate influenza vaccine 1562902A

Intervention Type: BIOLOGICAL

Intramuscular dose on Day 0 and Day 21

FluarixTM

Intervention Type: BIOLOGICAL

Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

Placebo

Intervention Type: BIOLOGICAL

Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

Interventions

GSK's candidate influenza vaccine 1562902A

Intramuscular dose on Day 0 and Day 21

Intervention Type: BIOLOGICAL

FluarixTM

Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

Intervention Type: BIOLOGICAL

Placebo

Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
• Female subjects of non-childbearing potential.
• Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
• Written informed consent obtained from the subject.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria

• Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .
• Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
• Previous administration of a pandemic influenza vaccine.
• Administration of licensed vaccines within 4 weeks prior to enrolment in this study.
• Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of chronic alcohol consumption and/or drug abuse.
• History of hypersensitivity to vaccines.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Acute disease and/or fever at the time of enrolment.
• Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination..
• Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

• Minimum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Curitiba/Paraná, Paraná, Brazil

Countries

Brazil

Other Identifiers

112865

Identifier Type: -

Identifier Source: org_study_id