Skip to main content
OpenTrials
Completed

NCT Number: NCT00476307

Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Dresden, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female aged 18 years or above;
  • Non-childbearing or using adequate contraception;
  • Written informed consent obtained from the subject.

Exclusion criteria

Subjects must not:

  • Participate in a trial or using non-registered product;
  • Use immunosuppressants, blood products, or another influenza vaccine during study;
  • Have virologically confirmed influenza within 1 year;
  • Have allergic or acute disease;
  • Have unstabilized serious chronic disease;
  • Be a lactating female.

Treatment and study plan

Fluarix™/Influsplit SSW® 2007/2008

Biological

Primary outcomes

  1. Immune response 21 days post vaccination

Secondary outcomes

  1. Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People Aged 18 Years or Above

Important dates

Study start
2007
Study completion
2007
First posted
May 22, 2007
Registry last updated
Nov 4, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.