The goal of this study is to assess the safety and immunogenicity of the seasonal and pandemic inactivated whole virion influenza vaccines produced with the production process set up by the NVI for technology transfer (proof of principle).
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: to assess the safety of seasonal and pandemic inactivated
whole virion influenza vaccine.
Secondary outcome
Secondary Objective(s): to assess immunogenicity of seasonal and pandemic
inactivated whole virion influenza vaccine, and to compare the safety profile
of the whole virion vaccines with a split virion vaccine.
Background summary
To increase availability of seasonal and especially pandemic influenza vaccines
for developing countries it is important that local vaccine production
facilities are established. NVI has set up an influenza vaccine production
process suitable for technology transfer to manufacturers in lower- and middle
income countries. The safety and immunogenicity of a monovalent seasonal and a
pandemic inactivated whole virion vaccine will be investigated.
Study objective
The goal of this study is to assess the safety and immunogenicity of the
seasonal and pandemic inactivated whole virion influenza vaccines produced with
the production process set up by the NVI for technology transfer (proof of
principle).
Study design
The study is a phase 1, double-blind, parallel, randomized, placebo-controlled
trial (N=120).
The seasonal and pandemic vaccines produced by NVI will be compared with a
commercial split virion seasonal vaccine as well as with a placebo. This
results in 3 study groups:
1. Egg-based pilot seasonal influenza vaccine 15 *g HA (n=60)
2. Egg-based pilot pandemic influenza vaccine 15 *g HA (n=30)
3. Commercial seasonal influenza vaccine 3x15 *g HA (split virion) (n=30)
Intervention
Three treatment arms will be included:
1. Seasonal influenza vaccine (one dose) and a placebo dose;
2. Pandemic influenza vaccine (two doses);
3. Commercial seasonal influenza vaccine (one dose) and a placebo dose.
Blood samples are drawn on screening, day 0, day 21 and on day 42. After each
dose, subjects are requested to complete a diary for five days to record
adverse events.
Study burden and risks
There are no benefits for the individual subjects in this trial. Subjects
should make four study visits. During each study visit, subjects are physically
examined and blood samples are drawn. The risks of venapuncture are considered
negligible. Subjects may experience adverse reactions to the vaccine. Subjects
should record adverse events in a diary. Adverse events are expected to be mild
and of short duration. The burden of participation in this study is considered
low.
Antonie van Leeuwenhoeklaan 9-11
3721 MA Bilthoven
NL
Antonie van Leeuwenhoeklaan 9-11
3721 MA Bilthoven
NL
Listed location countries
Age
Inclusion criteria
Age 18 to 49 years
Good health according to the investigator
Exclusion criteria
- having had an infectious disease with fever (including influenza) within the last 14 days
- present evidence of serious disease(s) demanding medical treatment that might interfere with the results of the study such as diseases which interfere with the immune system
- known or suspected allergy to any of the vaccine components: egg components, chicken protein, ovalbumin (by medical history)
- known or suspected immune deficiency
- history of any neurologic disorder, including epilepsy
- females: positive pregnancy test
- positive HIV, HBV or HCV serology
- previous vaccination with an influenza vaccine in the previous three winter seasons
- abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
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 |
|---|---|
| Other | 2695 |
| EudraCT | EUCTR2011-000159-17-NL |
| CCMO | NL35423.000.11 |