Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Annual Study for Fluarix Registration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00306943
First received: September 15, 2005
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/ Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).


Condition Intervention Phase
Prophylaxis Influenza Illness
Biological: Influsplit SSW®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase III Vaccination Study for Evaluation of Immunogenicity and Reactogenicity of Influsplit SSW 2004/2005 in People Age 18 or Beyond

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Investigation of the humoral immune response (haemagglutination inhibiting antibodies) in subjects

Secondary Outcome Measures:
  • Investigation of the safety and reactogenicity in subject's age 18 or elder past application of a doses of Influenza split vaccine 2005/2006 in relation to solicited and non-solicited incidents.

Estimated Enrollment: 120
Study Start Date: July 2005
Intervention Details:
    Biological: Influsplit SSW®
    Other Name: Influsplit SSW®
Detailed Description:

Since 1998 it is common practice within the European Community, to grant new licensees for Influenza Vaccines including the actual strain composition, by realizing the EU "Mutual Recognition Procedure" The procedure foresees the clinical testing of the vaccine before approval according to the particulars in the EU-Document CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines" of the "Committee for Proprietary Medical Products (CPMP) as Sub-Organization of the "European Agency for the Evaluation of Medicinal Products". Assessment of the Immunogenicity and Reactogenicity of the in its strain composition actualized, Influenza split vaccine2004/2005 (Influenza split vaccine 2005/2006) versus the criteria of the CPMP.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study.
  • All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004.
  • Written informed consent obtained from the subject must be available, after the subject has been informed in an understandable language.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature <37.5°C (99.5°F).
  • Acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Pregnancy (exclusion by safe contraception; pregnancy test at day 0.
  • Known allergic reactions, probably caused by one or more vaccine ingredients.
  • Drug and/or Alcohol abusers
  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: NCT00306943

Locations
Germany
GSK Investigational Site
Dresden, Sachsen, Germany, 01219
GSK Investigational Site
Dresden, Sachsen, Germany, 01277
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
GSK Investigational Site
Dresden, Sachsen, Germany, 01069
GSK Investigational Site
Dresden, Sachsen, Germany, 01187
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00306943     History of Changes
Other Study ID Numbers: 104745
Study First Received: September 15, 2005
Last Updated: November 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on November 25, 2014