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Completed

NCT Number: NCT00731029

Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03

This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Clinical Trials Call Center

Dresden, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
  • The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
  • Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.

Exclusion criteria

  • Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period
  • Acute disease at the beginning of the study
  • Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests
  • Pregnancy
  • Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
  • Known allergic reactions that might have been caused by one or more ingredients of the vaccine

Treatment and study plan

Thiomersal free trivalent influenza split vaccine 2002/2003

Biological

Single dose, intramuscular injection

GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003

Biological

Single dose, intramuscular injection

Primary outcomes

  1. GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.

    Time frame: On Day 21 (± 2) after vaccination

  2. Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms

    Time frame: Within 4 days after vaccination

Secondary outcomes

  1. Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms

    Time frame: Within 30 days after vaccination

  2. Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)

    Time frame: During the entire study period.

  3. Investigation of antibody persistence assessed by the criteria of the CHMP.

    Time frame: 11, 19, 27 weeks after vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Comparative Vaccination Study of the Reactogenicity and Immunogenicity of a Thiomersal-Free Formulation of Influsplit SSW® 2002/2003 Versus the Standard Formulation of Influsplit SSW® 2002/2003 in Individuals Over 18 Years

Important dates

Study start
2002
Primary completion
2003
First posted
Aug 8, 2008
Registry last updated
Aug 8, 2008

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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