CompletedPhase 1

Safety and Immunogenicity Of A Recombinant H5N1 Vaccine In Adults

United States100 participantsStarted 2010-11

Plain-language summary

The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults.

Age range18 Years – 49 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. At least 1 year post-menopausal
✓. Surgically sterile
✓. Will use oral, implantable, transdermal, or injectable contraceptives for 30 days prior to first vaccination and until 28 days after each vaccination
✓. Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the investigator (e.g., intrauterine device \[IUD\], female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner, or a sterile sexual partner) for study duration and until 28 days after vaccination

safety

Timeframe: 200 days

NCT IDNCT01250795

SponsorFraunhofer, Center for Molecular Biotechnology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07