Incidence of pandemic influenza and the immunogenicity of the pandemic vaccin.
Recruiting
- Conditions
- Influenza, pandemic (H1N1) 2009, fluInfluenza, pandemische griep, griep
- Registration Number
- NL-OMON29324
- Lead Sponsor
- etherlands Vaccin Institute
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 375
Inclusion Criteria
1. Good self-reported health according to the investigator;
2. Willingness and ability to adhere to the study regimen;
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of pandemic influenza incidence of vaccinated subjects compared to unvaccinated subjects.
- Secondary Outcome Measures
Name Time Method 1. Obtain data on immunogenicity of pandemic influenza vaccination;<br /><br>a. Evaluation of the humoral immune response to the vaccine and correlate this to protection against the virus;<br /><br>b. Evaluation of the cellular response to the vaccines and correlate this to protection against the virus;<br /><br>c. Evaluation of the response to the second dose of the pandemic influenza vaccine.<br /><br>2. Evaluation of cross-specific immune responses to pandemic H1N1 virus in the pre-vaccination samples;<br /><br>3. Evaluation of specific immune responses against pandemic H1N1 virus in infected, unvaccinated controls;<br /><br>4. Obtain data on immunogenicity of adjuvanted pandemic influenza A (H1N1) vaccination more than one year after vaccination;<br /><br>5. Evaluation of the boosting capacity of unadjuvanted seasonal influenza A (H1N1) vaccination;<br /><br>6. Evaluation of humoral and cellular immune responses against influenza A (H3N2) vaccine.