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

NCT01201902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2010-09-20

No results posted yet for this study

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.

Conditions

  • Influenza Infection

Interventions

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

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Woo-ju Kim · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2010-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201902 on ClinicalTrials.gov