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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Trivalent influenza subunit vaccine Influvac

• Registration Number: NCT00665509
• Lead Sponsor: Solvay Biologicals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-24
• Study Start: 2008-06
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-12
• Last Update Posted: 2008-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Trivalent influenza subunit vaccine Influvac	-

Primary Outcome Measures

Name	Time	Method
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009	2 and 3 weeks

Secondary Outcome Measures

Name	Time	Method
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)	2 and 3 weeks

Trial Locations

Locations (2)

Site 2; 🇩🇪 Hamburg, Germany

Site 1; 🇧🇪 Tessenderlo, Belgium