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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00731393
First received: August 7, 2008
Last updated: September 29, 2011
Last verified: September 2011

August 7, 2008
September 29, 2011
October 2003
August 2004   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00731393 on ClinicalTrials.gov Archive Site
  • Descriptive comparison of the occurrence and severity of solicited local and general symptoms [ Time Frame: Within 4 days after each vaccination ]
  • Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms [ Time Frame: Within 30 days after each vaccination ]
  • Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs). [ Time Frame: Throughout the study ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Influenza
  • Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
    2 doses, intramuscular injection
  • Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
    2 doses, intramuscular injection
    Other Names:
    • Thiomersal free trivalent influenza split vaccine 2003/2004
    • GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
  • Experimental: Group A
    Subjects aged between 6 months and 3 years.
    Intervention: Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
  • Experimental: Group B
    Subjects aged 3 to 6 years.
    Intervention: Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
  • Active Comparator: Group C
    Subjects aged between 6 months and 3 years.
    Intervention: Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
  • Active Comparator: Group D
    Subjects aged 3 to 6 years.
    Intervention: Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
Not Provided
August 2004   (final data collection date for primary outcome measure)

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.
Both
6 Months to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00731393
100351
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP