CompletedPhase 3

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

South Korea420 participantsStarted 2013-08

Plain-language summary

The purpose of this study is to evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

Who can participate

Age range18 Years – 60 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

Timeframe: 1st vaccination ~ 21 days after 2nd vaccination

Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody

Timeframe: 1st vaccination ~ 21 days after 2nd vaccination

GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination

Timeframe: 1st vaccination ~ 21 days after 2nd vaccination

The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination

Timeframe: Each vaccination ~ 7 days after each vaccination

The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination

Timeframe: 1st vaccination ~ 24 weeks after 2nd vaccination

Trial details

NCT IDNCT01987011

SponsorGreen Cross Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10

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