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

Sponsored by:	Solvay Biologicals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00665509

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 III

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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
1: Experimental	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

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

Responsible Party:	Solvay Pharmaceuticals ( Maaike Cronenberg )
Study ID Numbers:	S201.3.127, 2008-001038-28
Study First Received:	April 10, 2008
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00665509
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Germany: Paul-Ehrlich-Institut

Keywords provided by Solvay Pharmaceuticals:

Influenza
Vaccine
CHMP criteria

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009