Clinical trial NCT01987011: Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult Volunteers
Official title: Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Immunogenicity and Safety of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Avian influenza
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
Collaborators: name: Korean Center for Disease Control and Prevention
First posted: 2013-11-19
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: MG1109 is purified, inactivated influenza viral antigen.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40
timeFrame: 1st vaccination ~ 21 days after 2nd vaccination
measure: Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody
timeFrame: 1st vaccination ~ 21 days after 2nd vaccination
measure: 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
measure: 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
measure: 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
Secondary outcomes:
measure: GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination
timeFrame: 1st vaccination ~ 21 days after 2nd vaccination
measure: GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination
timeFrame: 1st vaccination ~ 21 days after 2nd vaccination
measure: Vital signs(body temperature, pulse)
timeFrame: 1st vaccination ~ 21 days after 2nd vaccination
measure: The results of physical examinations
timeFrame: 1st vaccination ~ 21 days after 2nd vaccination
measure: Lab results(Hematology, Blood chemistry, Urinalysis)
timeFrame: 1st vaccination ~ 21 days after 2nd vaccination
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Catholic University Of Korea ST. Vincent's Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: