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Completed

NCT Number: NCT00731393

Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04

The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bützow, Mecklenburg-Vorpommern, Germany

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
  • Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
  • All children included in the study must never have been given a prophylactic influenza inoculation.
  • Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an 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 until 30 days after administration of the second vaccine dose.
  • 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.
  • Known allergic reactions that might have been caused by one or more components of the vaccine.
  • Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.

Treatment and study plan

Thiomersal free trivalent influenza split vaccine 2003/2004

Biological

2 doses, intramuscular injection

GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004

Biological

2 doses, intramuscular injection

Other names: Thiomersal free trivalent influenza split vaccine 2003/2004

Primary outcomes

  1. GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.

    Time frame: On Day 21 (+- 2) after the second vaccination

Secondary outcomes

  1. Descriptive comparison of the occurrence and severity of solicited local and general symptoms

    Time frame: Within 4 days after each vaccination

  2. Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms

    Time frame: Within 30 days after each vaccination

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

    Time frame: Throughout the study

  4. GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.

    Time frame: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

To Determine the Immunogenicity and Reactogenicity of a Thiomersal Free Trivalent Influenza Split Vaccine 2003/2004 or of GSK Biologicals' Standard Formulation Influsplit SSW®/Fluarix™ 2003/2004 in Children Aged From 6 Months Until 6 Years

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Aug 11, 2008
Registry last updated
Sep 15, 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.

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