Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects
2 other identifiers
interventional
120
2 countries
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2008
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedAugust 13, 2008
August 1, 2008
1 month
April 10, 2008
August 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009
2 and 3 weeks
Secondary Outcomes (1)
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
2 and 3 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
3x 15mcg HA per 0.5 ml, trivalent one injection at Day 1
Eligibility Criteria
You may qualify if:
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
You may not qualify if:
- Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.
- A history of Guillain-Barré syndrome or active neurological disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Site 1
Tessenderlo, Belgium
Site 2
Hamburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
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
April 10, 2008
First Posted
April 24, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
August 13, 2008
Record last verified: 2008-08