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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039623

Enrollment

200

Registered

2009-12-25

Start date

2010-01-31

Completion date

2012-04-30

Last updated

2009-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

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

Interventions

BIOLOGICALPandemrix® (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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Age: 18-64 * Both genders * Healthy

Exclusion criteria

* Under 18 or above 64 * Not healthy

Design outcomes

Primary

Measure	Time frame
antibody levels	one year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026