A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

This study has been withdrawn prior to enrollment.
(Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866580
First received: March 19, 2009
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Pandemic Influenza
Biological: GSK's candidate influenza vaccine 1562902A
Biological: FluarixTM
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum HI antibody titres [ Time Frame: Day -30, Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum HI antibody titres [ Time Frame: Day -30, Day 42, Month 6, Month 12 ] [ Designated as safety issue: No ]
  • Serum neutralising antibody titres [ Time Frame: Day -30, Day 42, Month 6, Month 12 ] [ Designated as safety issue: No ]
  • Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: Day 0 - Day 6 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited adverse events [ Time Frame: Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of serious adverse events [ Time Frame: Day 0 - Month 6 ] [ Designated as safety issue: No ]
  • Occurrence of adverse events of specific interest [ Time Frame: Day 0 - Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: May 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   61 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866580

Locations
Brazil
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00866580     History of Changes
Other Study ID Numbers: 112865
Study First Received: March 19, 2009
Last Updated: February 24, 2011
Health Authority: Brazil: ANVISA

Keywords provided by GlaxoSmithKline:
Pandemic influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014