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

NCT00346723 | Completed Phase 3

• 2 other identifiers: S201.3.1252006-001300-37
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Keywords

Influenza, Vaccine, CHMP criteria

Outcome Measures

Primary Outcomes (1)

• Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2006/2007

Secondary Outcomes (1)

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

Interventions

Influvac® subunit influenza vaccine for i.m./deep s.c.injection BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead

Study Sites (1)

Site 1

Tessenderlo, Belgium

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Global Clinical Director Solvay

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: June 30, 2006
• Study Start: July 1, 2006
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

BE (1)