Status:
COMPLETED
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6-6 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00731393
Start Date
October 1 2003
End Date
August 1 2004
Last Update
September 15 2016
Active Locations (13)
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1
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, Germany, 18246
2
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18106
3
GSK Investigational Site
Bischofswerda, Saxony, Germany, 01877
4
GSK Investigational Site
Coswig, Saxony, Germany, 01640