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CompletedNCT00306943Updated Sep 21, 2016

Annual Study for Fluarix Registration

A Phase 3 interventional study of Influsplit SSW® in Influenza, sponsored by GlaxoSmithKline. Completed at 5 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-21.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Influenza
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Interventions

  • BiologicalInflusplit SSW®
06

What researchers measure

Primary outcomes

  1. Investigation of the humoral immune response (haemagglutination inhibiting antibodies) in subjects

Secondary outcomes

  1. 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.

07

Study locations

5 sites
  • GSK Investigational Site
    Dresden, Sachsen 01069, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01099, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01187, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01219, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01277, Germany
08

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00306943
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Mar 27, 2006
Start date
Jul 2005
Primary completion
Aug 2005
Completion
Aug 2005
Last update
Sep 21, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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