NCT01201902

A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine

Randomized, Open, Clinical Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine GC1116 With Adjuvant in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.

Detailed description

▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay 1. Proportion of subjects, stratified by group, with seroconversion to HI antibody 2. Proportion of subjects, stratified by group, achieving a serum hemagglutination inhibition assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus 3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer * Safety Outcome Measures : 1\. Solicited adverse events(Day 0 \~ 6, Day 21 \~ 27) 2. Unsolicited adverse events(Day 0 \~ 42) 3. Adverse events(Day 21 \~ 6 months)

Conditions

• Influenza Infection

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted influenza A(H1N1) vaccine	0.25ml, Intramuscular on Day 0 and 21
BIOLOGICAL	Adjuvanted influenza A(H1N1) vaccine	0.5ml, Intramuscular on Day 0 and 21
BIOLOGICAL	un-adjuvanted influenza A(H1N1) vaccine	0.5ml, Intramuscular on Day 0 and 21
BIOLOGICAL	Adjuvanted influenza A(H1N1) vaccine	0.25ml, Intramuscular on Day 0 and 21
BIOLOGICAL	Adjuvanted influenza A(H1N1) vaccine	0.5ml, Intramuscular on Day 0 and 21

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2010-09-15
• Last updated: 2010-09-20