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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

September 2, 2010
February 7, 2011
October 2010
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01195038 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
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

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Recombinant Influenza HA Vaccine (H5N1)
one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain
Other Name: UMN-0501
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
January 2011
January 2011   (final data collection date for primary outcome measure)

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

Both
21 Years to 41 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01195038
JPIP501-01b
No
UMN Pharma, Clinical Research Division
UMN Pharma Inc.
Not Provided
Not Provided
UMN Pharma Inc.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP