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

Hadassah Medical Center

Status: Unknown

Conditions: Healthy

Treatments: Biological: Pandemrix® (H1N1 pandemic influenza)

Study type: Interventional

Funder types: Other

Identifiers

NCT01039623

Vaccine-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 18-64
• Both genders
• Healthy

Exclusion criteria

• Under 18 or above 64
• Not healthy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)