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
1 other identifier
interventional
87
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2010
CompletedFirst Posted
Study publicly available on registry
September 3, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 8, 2011
February 1, 2011
3 months
September 2, 2010
February 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Day 21
Secondary Outcomes (2)
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
Days 7, 21
Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination
21 days
Interventions
one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain
Eligibility Criteria
You may qualify if:
- Subjects who completed a priming study (JPIP501-01a, NCT00980447)
- Male and female healthy adults
- Written informed consent obtained from the subject before study entry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMN Pharma Inc.lead
Study Sites (2)
UMN Investigational Site
Osaka, Japan
UMN Investigational Site
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2010
First Posted
September 3, 2010
Study Start
October 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 8, 2011
Record last verified: 2011-02