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
1 other identifier
interventional
157
1 country
13
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 Influsplit SSW® 2003/2004.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2003
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 7, 2008
CompletedFirst Posted
Study publicly available on registry
August 11, 2008
CompletedSeptember 15, 2016
September 1, 2016
10 months
August 7, 2008
September 14, 2016
Conditions
Keywords
Outcome Measures
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.
On Day 21 (+- 2) after the second vaccination
Secondary Outcomes (4)
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
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.
On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
Study Arms (4)
Group A
EXPERIMENTALSubjects aged between 6 months and 3 years.
Group B
EXPERIMENTALSubjects aged 3 to 6 years.
Group C
ACTIVE COMPARATORSubjects aged between 6 months and 3 years.
Group D
ACTIVE COMPARATORSubjects aged 3 to 6 years.
Interventions
2 doses, intramuscular injection
2 doses, intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (13)
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18106, Germany
GSK Investigational Site
Bischofswerda, Saxony, 01877, Germany
GSK Investigational Site
Coswig, Saxony, 01640, Germany
GSK Investigational Site
Dresden, Saxony, 01169, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Leipzig, Saxony, 04209, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Berlin, State of Berlin, 10315, Germany
GSK Investigational Site
Berlin, State of Berlin, 12627, Germany
GSK Investigational Site
Berlin, State of Berlin, 13355, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2008
First Posted
August 11, 2008
Study Start
October 1, 2003
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.