A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.

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

Study Overview

• Status: Withdrawn
• Conditions: Influenza
• Intervention / Treatment: Biological: GSK's candidate influenza vaccine 1562902A; Biological: FluarixTM; Biological: Placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Curitiba/Paraná, Paraná, Brazil, 80810-050
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: GSK's candidate influenza vaccine 1562902A; Intramuscular dose on Day 0 and Day 21; Biological: FluarixTM; Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule; Biological: Placebo; Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
Experimental: Group B	Biological: GSK's candidate influenza vaccine 1562902A; Intramuscular dose on Day 0 and Day 21; Biological: FluarixTM; Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule; Biological: Placebo; Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum HI antibody titres	Day -30, Day 42

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum HI antibody titres	Day -30, Day 42, Month 6, Month 12
Serum neutralising antibody titres	Day -30, Day 42, Month 6, Month 12
Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms	Day 0 - Day 6 after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited adverse events	Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination
Occurrence and relationship to vaccination of serious adverse events	Day 0 - Month 6
Occurrence of adverse events of specific interest	Day 0 - Month 12

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: March 19, 2009
• First Submitted That Met QC Criteria: March 19, 2009
• First Posted (Estimate): March 20, 2009

Study Record Updates

• Last Update Posted (Estimate): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Pandemic influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 112865