Influenza
Conditions
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 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 subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly)
Interventions
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Sponsors
Quintiles, Inc.
Abbott Biologicals
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
1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged \>= 18 and \<= 60 years or \>= 61 years of age at the day of study vaccination. 3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator
Exclusion criteria
1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. 2. A serious adverse reaction after a previous (influenza) vaccination. 3. Presence of any significant condition that may prohibit inclusion as determined by the investigator. 4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period. 5. A history of Guillain-Barré syndrome or active neurological disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines | 2 weeks |
| HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines | 3 weeks |
Countries
Belgium, Germany
Outcome results
None listed