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OpenTrials
Completed

NCT Number: NCT00363870

A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A male or female age between 18 and 64 years at the time of the first vaccination.
  • non-childbearing female

Exclusion criteria

  • Use of non-registered products
  • Pregnancy
  • Hypersensitivity to a previous dose of influenza vaccine
  • Acute disease at the time of enrolment/vaccination.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine
  • Administration of any other influenza vaccine for the season 2006-2007
  • Chronic disorders of the pulmonary or cardiovascular system, including asthma.
  • Administration of immune-modifying drugs
  • Administration of immunoglobulins and/or any blood products
  • History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)

Treatment and study plan

Fluarix vaccine

Biological

Primary outcomes

  1. occurrence of confirmed influenza

Secondary outcomes

  1. occurrence of influenza like illness

  2. Occurrence of pneumonia

  3. Immune response at days 0 and 21

  4. Safety during 7 Months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2006
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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