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Thymosin alpha 1 dose-ranging pilot study to enhance H1N1 vaccine immunogenicity in adults with ESRD on chronic dialysis
2009-016362-85Phase 2Completed
- Sponsor
- Leadiant Biosciences
- Start
- Dec 2009
- Modality
- Modified Peptides → Peptides, Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Countries
- 1
01
Overview
Phase 2, randomised, open-label trial of thymosin alpha 1 and influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted) in influenza A virus infection (H1N1) (3 arms), sponsored by Leadiant Biosciences. Primary endpoints: CHMP/EMEA immunogenicity success criteria at Day 21 by hemagglutination inhibition, Number and percentage of immunogenicity successes by treatment group and 2 more. Started Dec 2009; status: completed.
02
Drugs
thymosin alpha 1influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted)
03
Conditions
influenza A virus infection (H1N1)
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