Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference
Not Applicable
- Conditions
- Healthy
- Registration Number
- NCT01039623
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.
- Detailed Description
Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Age: 18-64
- Both genders
- Healthy
Exclusion Criteria
- Under 18 or above 64
- Not healthy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method antibody levels one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israel