Trial intelligence / Profile preview

MG1109 H5N1 vaccine in healthy adults

NCT01987011Phase 3

Key facts

Status: Completed
Start: Aug 2013
Primary completion: Oct 2013
Countries: 1
Sponsor: GC Biopharma
Modality: Vaccines & Immunotherapeutics

Drugs: MG1109
Conditions: Influenza A H5N1 infection (H5N1)

Overview

Phase 3, randomised, double-blind trial in Influenza A H5N1 infection (H5N1) comparing MG1109 with Placebo (2 arms). Primary endpoints: Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 at Day 42, Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody at Day 42 and 3 more. Started Aug 2013; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

MG1109
MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days
Placebo
Placebo 0.5 mL Intramuscularly injection, twice at an interval of 21 days

Who it enrols

Healthy adults without history of exposure to H5N1 subtype or vaccine, and without immune system disorders.

Endpoints

Primary

Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40Day 42
Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibodyDay 42
Geometric Mean Ratio of Hemagglutination Inhibition(HI) antibody titerDay 42
Percentage of subjects reporting solicited adverse eventsDay 0 to Day 28
Percentage of subjects reporting unsolicited adverse eventsDay 0 to Week 24

Secondary

Geometric Mean Titer of Hemagglutination Inhibition(HI) antibody titerDay 42
Geometric Mean Titer and Geometric Mean Ratio of neutralizing antibody titerDay 42
Vital signs (body temperature, pulse)Day 42
Results of physical examinationsDay 42
Lab results (Hematology, Blood chemistry, Urinalysis)Day 42

Beyond the preview

Go deeper on NCT01987011.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01987011.