NCT01039623

Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

Randomized Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Pandemrix® (H1N1 pandemic influenza)	vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2009-12-25
• Last updated: 2009-12-25

Locations

1 site across 1 country: Israel