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This study has been withdrawn prior to enrollment.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
  Purpose

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).


Condition Intervention Phase
Healthy Volunteers
Biological: Trivalent virosomal influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Invivac® 2006/2007

Secondary Outcome Measures:
  • HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)

Estimated Enrollment: 120
Study Start Date: June 2006
  Eligibility

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

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).
  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: NCT00345462

Locations
Germany
Site 1
Berlin, Germany
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00345462     History of Changes
Other Study ID Numbers: S206.3.012, 2006-001301-28
Study First Received: June 27, 2006
Last Updated: February 5, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Solvay Pharmaceuticals:
Influenza, Vaccine, CHMP criteria

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 28, 2014