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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01039623
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 27
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: Pandemrix® (H1N1 pandemic influenza)	N/A

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
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Apr 1, 2012

Outcome Measures

Primary Outcome Measures

1. antibody levels [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age: 18-64

• Both genders

• Healthy

Exclusion Criteria:

• Under 18 or above 64

• Not healthy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01039623
• Other Study ID Numbers: Vaccine-HMO-CTIL
• First Posted: Dec 25, 2009
• Last Update Posted: Dec 25, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Healthy volunteers

Study Results

No Results Posted as of Dec 25, 2009