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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987011
• Other study ID #: MG1109_P3
• Status: Completed
• Phase: Phase 3
• First received: July 22, 2013
• Last updated: July 1, 2015
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

MG1109 is purified, inactivated influenza viral antigen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• MG1109

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Catholic University Of Korea ST. Vincent's Hospital	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Green Cross Corporation	Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer = 1:40		1st vaccination ~ 21 days after 2nd vaccination	No
Primary	Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody		1st vaccination ~ 21 days after 2nd vaccination	No
Primary	GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination		1st vaccination ~ 21 days after 2nd vaccination	No
Primary	The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination		Each vaccination ~ 7 days after each vaccination	Yes
Primary	The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination		1st vaccination ~ 24 weeks after 2nd vaccination	Yes
Secondary	GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination		1st vaccination ~ 21 days after 2nd vaccination	No
Secondary	GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination		1st vaccination ~ 21 days after 2nd vaccination	No
Secondary	Vital signs(body temperature, pulse)		1st vaccination ~ 21 days after 2nd vaccination	Yes
Secondary	The results of physical examinations		1st vaccination ~ 21 days after 2nd vaccination	Yes
Secondary	Lab results(Hematology, Blood chemistry, Urinalysis)		1st vaccination ~ 21 days after 2nd vaccination	Yes