Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

This study has been completed.

Sponsor:

Information provided by:

UMN Pharma Inc.

ClinicalTrials.gov Identifier:

NCT01195038

First received: September 2, 2010

Last updated: February 7, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 2, 2010
Last Updated Date	February 7, 2011
Start Date ^ICMJE	October 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2010)	Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004) [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01195038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 2, 2010)	Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses [ Time Frame: Days 7, 21 ] [ Designated as safety issue: No ] Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
Official Title ^ICMJE	A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine
Brief Summary	The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Influenza
Intervention ^ICMJE	Biological: Recombinant Influenza HA Vaccine (H5N1) one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain Other Name: UMN-0501
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	87
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects who completed a priming study (JPIP501-01a, NCT00980447) Male and female healthy adults Written informed consent obtained from the subject before study entry Exclusion Criteria: History of H5N1 influenza or vaccination of other H5N1 influenza vaccines Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines) Treatment with disallowed drugs including other study drugs Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Gender	Both
Ages	21 Years to 41 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01195038
Other Study ID Numbers ^ICMJE	JPIP501-01b
Has Data Monitoring Committee	No
Responsible Party	UMN Pharma, Clinical Research Division
Study Sponsor ^ICMJE	UMN Pharma Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	UMN Pharma Inc.
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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