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Clinical Trials/NCT01039623
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

Sponsor Class
Other

Study Sites (1)

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