NCT01039623UnknownNot Applicable
Randomized Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference
Hadassah Medical Organization1 site in 1 country200 target enrollmentStarted: January 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- antibody levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 18-64
- •Both genders
Exclusion Criteria
- •Under 18 or above 64
- •Not healthy
Outcomes
Primary Outcomes
antibody levels
Time Frame: one year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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