No registrations found.
ID
Source
Brief title
Health condition
Influenza, pandemic (H1N1) 2009, flu
Influenza, pandemische griep, griep
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of pandemic influenza incidence of vaccinated subjects compared to unvaccinated subjects.
Secondary outcome
1. Obtain data on immunogenicity of pandemic influenza vaccination;
a. Evaluation of the humoral immune response to the vaccine and correlate this to protection against the virus;
b. Evaluation of the cellular response to the vaccines and correlate this to protection against the virus;
c. Evaluation of the response to the second dose of the pandemic influenza vaccine.
2. Evaluation of cross-specific immune responses to pandemic H1N1 virus in the pre-vaccination samples;
3. Evaluation of specific immune responses against pandemic H1N1 virus in infected, unvaccinated controls;
4. Obtain data on immunogenicity of adjuvanted pandemic influenza A (H1N1) vaccination more than one year after vaccination;
5. Evaluation of the boosting capacity of unadjuvanted seasonal influenza A (H1N1) vaccination;
6. Evaluation of humoral and cellular immune responses against influenza A (H3N2) vaccine.
Background summary
We will investigate the incidence of pandemic influenza in healthy adults between 18 and 52 years of age that have either received the pandemic influenza vaccine or not and analyze whether humoral and cellular immune responses correlate with protection against influenza. The findings will have important implications for future pandemic and seasonal influenza vaccination campaigns.
Study objective
Evaluation of pandemic influenza incidence of vaccinated subjects compared to unvaccinated subjects in correlation with immunogenicity of the vaccine.
Study design
Timepoint 1: Presample blood and first vaccination;
Timepoint 2: Bloodsample 10-14 days after vaccination;
Timepoint 3: Bloodsample 3 weeks after first vaccination and second vaccination;
Timepoint 4: Blood sampling 3 weeks after second vaccination;
Timepoint 5: Nose swab, applicable if influenza-like illness is reported;
Timepoint 6: Bloodsampling at end of pandemic;
Timepoint 7: Bloodsample 1 year after vaccination;
Timepoint 8: Bloodsample 3 weeks after timepoint 7 (if additional influenza vaccination is administered);
Timepoint 9: Bloodsample at end of influenza season 2010/2011.
Intervention
Healthy adults will be vaccinated 2 times with a 3 week interval with the pandemic influenza vaccin Focetria (Novartis). At the described timepoints blood sampling will take place for immunological analysis. In the control group, individuals will not be vaccinated and bloodsampling will take place at timepoint 1 and 6.
In both groups, a nose swab will be taken when an individual reports influenza-like symptoms to confirm the presence of pandemic H1N1 virus. Primary endpoint of the study is the difference in the percentage of individuals infected with the pandemic influenza virus in both arms of the study.
Postbus 457
J. Beek, van
NVI,
Postbak 117
Bilthoven 3720 AL
The Netherlands
+31 (0)30-2743184
josine.van.beek@nvi-vaccin.nl
Postbus 457
J. Beek, van
NVI,
Postbak 117
Bilthoven 3720 AL
The Netherlands
+31 (0)30-2743184
josine.van.beek@nvi-vaccin.nl
Inclusion criteria
1. Good self-reported health according to the investigator;
2. Willingness and ability to adhere to the study regimen;
3. Having a signed informed consent (IC) form;
4. Age 18 – 65 years.
Exclusion criteria
The exclusion criteria with regard to contra-indications for receiving the pandemic influenza vaccine are:
1. Allergy to any of the components of the vaccine or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
The exclusion criteria with regard to blood collection and the immunological analysis are:
1. Immune deficiencies;
2. Haematological disorders;
3. Bleeding disorders;
4. Usage of anticoagulants, corticosteroids, NSAIDs and/or statins;
5. Diabetes mellitus;
6. Having had an infectious disease with fever within the last two weeks;
7. Previously diagnosed with pandemic H1N1 influenza.
Design
Recruitment
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 |
---|---|
NTR-new | NL1952 |
NTR-old | NTR2070 |
Other | NVI/NL : 255/29241.000.09 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |