NCT00479921

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).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 healthy-volunteers

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

First QC Date

May 29, 2007

Last Update Submit

January 29, 2009

Conditions

Healthy Volunteers

Keywords

InfluenzaVaccineCHMP criteria

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2007/2008

Secondary Outcomes (1)

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

Interventions

Trivalent influenza subunit vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 serious systemic and/or local 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 1

Tessenderlo, Belgium

Location

Site 2

Hamburg, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory 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

May 29, 2007

First Posted

May 30, 2007

Study Start

June 1, 2007

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

DE(1)BE(1)