- To assess the safety and tolerability of a nonadjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups;- To assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Griep
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Frequency and severity of systemic reactions after the first, second and
third vaccinations.
Secondary outcome
- Frequency and severity of injection site reactions after the first, second
and third vaccinations;
- Number of subjects with fever, malaise or shivering with onset within 7 days
after the first, second and third vaccinations;
- Frequency and severity of adverse events (AEs) observed during the entire
study period.
Background summary
Influenza is a highly contagious viral infection frequently causing a severe
disease characterized by systemic symptoms (e.g. headache, tenderness or pain
in the muscles, chills, fever) as well as symptoms from the involvement of the
respiratory tract. The H5N1 influenza virus, also known as avian influenza
virus, predominantly infects birds. It is of particular concern as it may cause
severe disease in humans if infection occurs. So far the number of infected
humans worldwide is limited. However, the reported proportion of humans having
died from infection with this H5N1 influenza virus is very high. There are
different strains of H5N1 influenza viruses, that have been responsible for
infection of humans in different parts of the world.
Vaccination against pandemic influenza is considered to be the most effective
option to limit the spread of a pandemic strain. Therefore, effective vaccines
against highly pathogenic avian influenza H5N1 viruses are an urgent and global
public health priority
Study objective
- To assess the safety and tolerability of a nonadjuvanted H5N1 influenza
vaccine in an adult and elderly population and in specified risk groups;
- To assess the immune response to a non-adjuvanted H5N1 influenza vaccine in
an adult and elderly
population and in specified risk groups;
- To assess the persistence of H5N1 influenza antibodies after vaccination with
a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and
in specific risk groups.
- To demonstrate consistency of immune response among three different lots of a
non-adjuvanted H5N1 influenza vaccine
Study design
Open-label, multicenter research study with 3 cohorts and different treatment
groups
Intervention
Subjects in
Cohort 1 stratum A treatment group 1
Cohort 1 stratum A treatment group 3
Cohort 1 stratum A treatment group 4
Cohort 1 stratum B treatment group 1
Cohort 2
Cohort 3
receive 2 x 0,5 ml vaccin (7,5 microgram A/Vietnam/1203/2004) intramuscular
subjects in
Cohort 1 stratum A treatment group 2
Cohort 1 stratum B treatment group 2
receive 2 x 0,5 ml vaccin (3,75 microgram A/Vietnam/1203/2004) intramuscular
In the Netherlands only healthy subjects in Cohort 1 Stratum A treatment group
4 will be recruited
Study burden and risks
The risks consists of the possibility of side effects. The most commonly
observed side effects were injection site pain, headache, fatigue, and muscle
pain. Mild fever, malaise, joint pain, shivering, sweating, dizziness, vertigo,
upper respiratory tract pain as well as redness, swelling, hardening and
bruising at the injection site also occurred at a common frequency.
As with any vaccination, allergic reactions, very rarely central or peripheral
nervous system disturbances may occur. In addition, vaccination may cause a
flare or progression of a pre-existing autoimmune disease.
The burden consists of 2 intramuscular injections and the completion of a diary
with symptoms throughout the whole study period. In addition, the subject will
be asked to visit the research center 5 times in total. 4 times a physical
examination will be done. For subjects in treatment group 4 in addition to the
above a blood sample (30 ml) will be taken 3 times.
The subjects of TG 4 that participate in the extension study must visit the
clinic for 2 more times with 2 times a blood draw and 2 times a physicial exam
and one time a booster vaccination.
Industriestrasse 67
1220 Wenen
Oostenrijk
Industriestrasse 67
1220 Wenen
Oostenrijk
Listed location countries
Age
Inclusion criteria
-Are 18 years of age or older
-Agree to keep a daily record of symptoms for the duration of the study
-Are generally healthy, as determined by the investigator*s clinical judgment
through collection of medical history and performance of a physical
examination.
Exclusion criteria
-Have a history of exposure to H5N1 virus or a history of vaccination with an
H5N1 influenza vaccine;
-Are at high risk of contracting H5N1 influenza infection
-Have a history of severe allergic reactions or anaphylaxis;
-Have a rash, dermatological condition or tattoos which may interfere with
injection site reaction rating;
-Have received any live vaccine within 4 weeks or inactivated vaccine within 2
weeks prior to vaccination in this study;
-Currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000558-11-NL |
| CCMO | NL23153.000.08 |