Annual Study to Investigate Inactivated Virosomal Influenza Vaccine for the 2006/2007 Influenza Season in Europe.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00345462
First received: June 27, 2006
Last updated: February 5, 2010
Last verified: February 2010

June 27, 2006
February 5, 2010
June 2006
Not Provided
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Invivac® 2006/2007
Same as current
Complete list of historical versions of study NCT00345462 on ClinicalTrials.gov Archive Site
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
Same as current
Not Provided
Not Provided
 
Annual Study to Investigate Inactivated Virosomal Influenza Vaccine for the 2006/2007 Influenza Season in Europe.
Immunogenicity and Reactogenicity of Trivalent Virosomal Influenza Vaccine Invivac® for the Season 2006/2007. An Open, Baseline-controlled Study in Two Groups of Healthy Subjects: Adults and Elderly.

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available virosomal vaccine (Invivac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza virosomal vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy Volunteers
Biological: Trivalent virosomal influenza vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
120
Not Provided
Not Provided

Inclusion Criteria:

  • Signed and dated informed consent.
  • Healthy and aged >= 18 and <= 60 years or >= 61 years of age.
  • Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire."

Exclusion Criteria:

  • Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
  • Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
  • Having experienced a documented serious systemic reaction after previous influenza vaccination.
  • Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
  • Having received vaccination against influenza within the previous six months before Visit 1.

Exclusion criteria only for female subjects aged >=18 and <=60 years and of childbearing potential:

  • Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
  • Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00345462
S206.3.012, 2006-001301-28
Not Provided
Not Provided
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP