CompletedPhase 1/2

Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers

South Korea346 participantsStarted 2010-02

Plain-language summary

This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

Who can participate

Age range18 Years – 58 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.

Inclusion Criteria: * Healthy adults who are available for follow-up during the study Exclusion Criteria: * Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine * Subjects with immune system disorder including immune deficiency disease

What they're measuring

Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group

Timeframe: 42 days after vaccination

Number of subjects with Solicited / Unsolicited adverse events

Timeframe: With in 24 weeks after vaccination

Trial details

NCT IDNCT01389466

SponsorGreen Cross Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-11

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