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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00731393
First received: August 7, 2008
Last updated: September 14, 2016
Last verified: September 2016
  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
Study Completion Date: August 2004
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 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

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731393

Locations
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 100351
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 
Study First Received: August 7, 2008
Last Updated: September 14, 2016
Health Authority: Germany: Pau-Ehrlich Institute
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 26, 2016