Phase I/II study to evaluate the safety and immunogenicity of MG1109 in healthy adult volunteers

Randomized phase I/II study to evaluate the safety and immunogenicity of ‘MG1109(egg-based, pre-pandemic influenza(H5N1) vaccine)’ administered intramuscularly in healthy adult volunteers

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000119

Enrollment

346

Registered

2011-05-31

Start date

2010-02-11

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine : Investigational Product : MG1109(purified, inactivated influenza viral antigen) Dose : 0.125 mL ~ 1.0 mL Administration method : intramuscularly injection, twice at an interval of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy adults who are available for follow-up during the study

Exclusion criteria

Exclusion criteria: 1. Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine 2. Subjects with immune system disorder including immune deficiency disease

Design outcomes

Primary

Measure	Time frame
HI antibody titer;HI antibody seroconversion rate;HI antibody titer GMR;Solicited / Unsolicited adverse events	—

Secondary

Measure	Time frame
HI antibody titer GMT;Neutralizing antibody GMR & GMT;Vital signs / Physical examination / Laboratory test	—

Countries

Korea, Republic of

Contacts

Public ContactWoo Kim

Koera University Guro Hospital

Outcome results