Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00372255
First received: September 5, 2006
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.


Condition Intervention Phase
Influenza
Biological: Influsplit SSW® 2005/2006
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open, Phase IV Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • immune response in children 6-9 years

Secondary Outcome Measures:
  • immune response in children 10-13 years, symptoms and safety of the vaccine in children 6-13 years

Estimated Enrollment: 240
Study Start Date: November 2005
Intervention Details:
    Biological: Influsplit SSW® 2005/2006
    Other Name: Influsplit SSW® 2005/2006
  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children or children with an increased health risk due to an underlying chronic disease—such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases—aged between 6 and 13 years.
  • All subjects must not have received a prior influenza vaccination.
  • All subjects must not have had a prior influenza disease.

Exclusion Criteria:

  • Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
  • Acute illness at the start of the study.
  • Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
  • Known allergic reactions which might be caused by the ingredients of the vaccine.
  • Girls post-menarche: pregnancy or positive pregnancy-test
  • Multiple sclerosis or congenital or acquired immunodeficiencies.
  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: NCT00372255

Locations
Germany
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18106
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
GSK Investigational Site
Dresden, Sachsen, Germany, 01159
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Dresden, Sachsen, Germany, 01169
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
GSK Investigational Site
Leipzig, Sachsen, Germany, 04317
GSK Investigational Site
Wurzen, Sachsen, Germany, 04808
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 10315
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00372255     History of Changes
Other Study ID Numbers: 106252
Study First Received: September 5, 2006
Last Updated: September 29, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

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 August 26, 2014