Assessment of the humoral immune response and safety of reduced doses of influenza vaccine administered intradermally compared to intramuscular administratio
Completed
- Conditions
- InfluenzaInfections and Infestations
- Registration Number
- ISRCTN33950739
- Lead Sponsor
- Berna Biotech AG, Crucell Company (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 275
Inclusion Criteria
Healthy volunteers between 18 and 60 years of age.
Exclusion Criteria
1. Pregnancy and lactation
2. Treatment with immunoglobulins or blood transfusions
3. Immunodeficiency
4. History of egg protein allergy/severe atopy/serious adverse reaction to influenza vaccine
5. Previous vaccination against influenza in the past 330 days
6. Participation in another clinical trial
7. Known blood coagulation disorders
8. Acute febrile illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity, assessed by blood tests. Blood was collected before and approximately three weeks after vaccination.
- Secondary Outcome Measures
Name Time Method Safety will be assessed at baseline and at 3 weeks after vaccination, including a 4-day adverse event questionnaire, soliciting a set of local and systemic Adverse Events (AEs) according to the European Medicines Agency (EMEA) specifications.