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Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

NCT00980447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-02-08

No results posted yet for this study

Summary

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).

The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults.

Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.

Conditions

Interventions

BIOLOGICAL

UMN-0501

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart

BIOLOGICAL

UMN-0501

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart

BIOLOGICAL

UMN-0501

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart

Sponsors & Collaborators

  • UMN Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Tetsuo Nakayama, MD, PhD · Kitasato University Kitasato Institute for Life Sciences

  • Suminobu Ito, MD, PhD · National Hospital Organization

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

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Entities

Diseases

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 NCT00980447 on ClinicalTrials.gov