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

Immunogenicity and Reactogenicity of Trivalent Virosomal Influenza Vaccine Invivac® for the Season 2006/2007. An Open, Baseline-controlled Study in Two Groups of Healthy Subjects: Adults and Elderly.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345462

Enrollment

120

Registered

2006-06-28

Start date

2006-06-30

Completion date

Unknown

Last updated

2010-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Influenza, Vaccine, CHMP criteria

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 virosomal vaccine (Invivac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza virosomal vaccine in two groups of healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).

Interventions

BIOLOGICALTrivalent virosomal influenza vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Invivac® 2006/2007	—

Secondary

Measure	Time frame
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026