|- candidate number||8926|
|- NTR Number||NTR2695|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jan-2011|
|- Secondary IDs||NVI-253 / NL35423.000.11 ; Nederlands Vaccin Instituut / CCMO|
|- Public Title||Safety and immunogenicity of whole virion influenza vaccines.|
|- Scientific Title||Safety and immunogenicity of seasonal and pandemic inactivated whole virion influenza vaccine in healthy adults.|
|- hypothesis||1. Assessment of safety of seasonal and pandemic inactivated whole virion influenza vaccines;|
2. Assessment of immunogenicity of the whole virion vaccines;
3. Comparison of the safety profile of the whole virion vaccines with a split virion vaccine.
|- Healt Condition(s) or Problem(s) studied||Influenza|
|- Inclusion criteria||1. Age 18 to 49 years;|
2. If female: Willing to use contraceptive measures during the study;
3. Good health according to the investigator;
4. Willing and able to adhere to the study regimen;
5. Having a signed informed consent form.
|- Exclusion criteria||1. Having had an infectious disease with fever (including influenza) within the last 14 days;|
2. 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;
3. Known or suspected allergy to any of the vaccine components: egg components, chicken protein, ovalbumin (by medical history);
4. Known or suspected immune deficiency;
5. History of any neurologic disorder, including epilepsy;
6. Females: Positive pregnancy test;
7. Positive HBV or HCV serology;
8. Previous vaccination with an influenza vaccine in the previous winter season (2010-2011);
9. Previous vaccination with any vaccine within 3 months before screening;
10. Previous administration of plasma products (including immunoglobulins) within 3 months before vaccination;
11. Systemic treatment with corticosteroids within one month before screening;
12. Blood donation within one month before screening;
13. Participation in another clinical trial within three months before screening;
14. Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2011|
|- planned closingdate||30-sep-2011|
|- Target number of participants||150|
|- Interventions||Four treatment arms will be included:|
1. Seasonal influenza vaccine (one dose) and a placebo dose;
2. Pandemic influenza vaccine (two doses);
3. Placebo (two doses);
4. Commercial seasonal influenza vaccine (one dose) and a placebo dose.
Blood samples are drawn on screening, day 0 (prior to vaccine/placebo administration), day 21 (prior to vaccine/placebo administration), and on day 42. After each vaccine/placebo dose, subjects are requested to complete a diary for five days to record adverse events.
|- Primary outcome||The incidence of systemic and local adverse events.|
|- Secondary outcome||Anti-hemagglutinin antibody against the influenza vaccine strain by HI test.|
|- Timepoints||Blood samples are drawn on screening, day 0 (prior to vaccine/placebo administration), day 21 (prior to vaccine/placebo administration), and on day 42.
After each vaccine/placebo dose, subjects are requested to complete a diary for five days to record adverse events.
|- Trial web site||http://www.itpiv.nl/|
|- CONTACT FOR PUBLIC QUERIES|| R.A.J. Boxtel, van|
|- CONTACT for SCIENTIFIC QUERIES|| R.A.J. Boxtel, van|
|- Sponsor/Initiator ||Rijksinstituut voor Volksgezondheid en Milieu (RIVM)|
(Source(s) of Monetary or Material Support)
|World Health Organization (WHO)|
|- Brief summary||To increase availability of seasonal and especially pandemic influenza vaccines for developing countries it is important that local vaccine production facilities are established. The Netherlands Vaccine Institute (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. |
|- Main changes (audit trail)|
|- RECORD||13-jan-2011 - 24-jun-2011|