Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00665509
First received: April 10, 2008
Last updated: August 12, 2008
Last verified: August 2008
  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 vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).


Condition Intervention Phase
Influenza
Biological: Trivalent influenza subunit vaccine Influvac
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, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects

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 Influvac® 2008/2009 [ Time Frame: 2 and 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP) [ Time Frame: 2 and 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml, trivalent one injection at Day 1

  Eligibility

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

Inclusion Criteria:

  • Willing and able to give informed consent and able to adhere to all protocol required study procedures.
  • Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
  • Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

  • Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
  • A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
  • Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.
  • A history of Guillain-Barré syndrome or active neurological disease.
  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: NCT00665509

Locations
Belgium
Site 1
Tessenderlo, Belgium
Germany
Site 2
Hamburg, Germany
Sponsors and Collaborators
Solvay Biologicals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Maaike Cronenberg, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00665509     History of Changes
Other Study ID Numbers: S201.3.127, 2008-001038-28
Study First Received: April 10, 2008
Last Updated: August 12, 2008
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
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 19, 2014