Clinical trial NCT00346723: Annual Study to Investigate Inactivated Subunit Influenza Vaccine for the 2006/2007 Influenza Season in Europe.
Official title: Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac® for the Season 2006/2007. An Open, Baseline-Controlled Study in Two Groups of Healthy Subjects: Adults and Elderly.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers
Keywords: Influenza, Vaccine, CHMP criteria
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Exclusion criteria only for female subjects aged \>=18 and \<=60 years and of childbearing potential:

* 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).

Primary outcomes:
measure: Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2006/2007
Secondary outcomes:
measure: HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
Other outcomes:
Locations:
city: Tessenderlo
country: Belgium
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: