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:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00731393
First received: August 7, 2008
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Thiomersal free trivalent influenza split vaccine 2003/2004 Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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 ]
| Enrollment: | 157 |
| Study Start Date: | October 2003 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Names:
|
|
Active Comparator: Group D
Subjects aged 3 to 6 years.
|
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
2 doses, intramuscular injection
Other Names:
|
Eligibility| Ages Eligible for Study: | 6 Months to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731393
Locations
| Germany | |
| GSK Investigational Site | |
| Buetzow, Mecklenburg-Vorpommern, Germany, 18246 | |
| 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, 12627 | |
| GSK Investigational Site | |
| Berlin, Germany, 10315 | |
| GSK Investigational Site | |
| Berlin, Germany, 13355 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00731393 History of Changes |
| Other Study ID Numbers: | 100351 |
| Study First Received: | August 7, 2008 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Germany: Pau-Ehrlich Institute |
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 |
ClinicalTrials.gov processed this record on June 17, 2013