A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

NCT00866580 | Withdrawn Phase 3

• 1 other identifier: 112865
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Pandemic influenza

Outcome Measures

Primary Outcomes (1)

• Serum HI antibody titres

  Day -30, Day 42

Secondary Outcomes (6)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Biological: GSK's candidate influenza vaccine 1562902A; Biological: FluarixTM; Biological: Placebo

Group B

EXPERIMENTAL

Biological: GSK's candidate influenza vaccine 1562902A; Biological: FluarixTM; Biological: Placebo

Interventions

GSK's candidate influenza vaccine 1562902A BIOLOGICAL

Intramuscular dose on Day 0 and Day 21

Group A; Group B

FluarixTM BIOLOGICAL

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

Group A; Group B

Placebo BIOLOGICAL

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

Group A; Group B

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Curitiba/Paraná, Paraná, 80810-050, Brazil

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: May 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

BR (1)