Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
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ClinicalTrials.gov Identifier: NCT00731393 |
Recruitment Status
:
Completed
First Posted
: August 11, 2008
Last Update Posted
: September 15, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Thiomersal free trivalent influenza split vaccine 2003/2004 Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 157 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official 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 |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | August 2004 |
Actual Study Completion Date : | August 2004 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A
Subjects aged between 6 months and 3 years.
|
Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
2 doses, intramuscular injection
|
Experimental: Group B
Subjects aged 3 to 6 years.
|
Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
2 doses, intramuscular injection
|
Active Comparator: Group C
Subjects aged between 6 months and 3 years.
|
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
2 doses, intramuscular injection
Other Name: Thiomersal free trivalent influenza split vaccine 2003/2004
|
Active Comparator: Group D
Subjects aged 3 to 6 years.
|
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
2 doses, intramuscular injection
Other Name: Thiomersal free trivalent influenza split vaccine 2003/2004
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 6 Months to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731393
Germany | |
GSK Investigational Site | |
Buetzow, Mecklenburg-Vorpommern, Germany, 18246 | |
GSK Investigational Site | |
Rostock, Mecklenburg-Vorpommern, Germany, 18106 | |
GSK Investigational Site | |
Bischofswerda, Sachsen, Germany, 01877 | |
GSK Investigational Site | |
Coswig, Sachsen, Germany, 01640 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01169 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01307 | |
GSK Investigational Site | |
Leipzig, Sachsen, Germany, 04209 | |
GSK Investigational Site | |
Bad Segeberg, Schleswig-Holstein, Germany, 23795 | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24937 | |
GSK Investigational Site | |
Husum, Schleswig-Holstein, Germany, 25813 | |
GSK Investigational Site | |
Berlin, Germany, 10315 | |
GSK Investigational Site | |
Berlin, Germany, 12627 | |
GSK Investigational Site | |
Berlin, Germany, 13355 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00731393 History of Changes |
Other Study ID Numbers: |
100351 |
First Posted: | August 11, 2008 Key Record Dates |
Last Update Posted: | September 15, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Keywords provided by GlaxoSmithKline:
Thiomersal-free influenza split vaccine 2003/2004 Influsplit SSW®/Fluarix™ 2003/2004 Influenza |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |