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

H

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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