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Immunogenicity Study of S-OIV H1N1 Influenza Vaccine

NCT01096225 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2010-04-12

No results posted yet for this study

Summary

The primary immunogenicity objective is to assess the antibody response and T-cell response of split-virion inactivated A (H1N1) vaccine. Participants will include up to 20 healthy persons of age 20 and older who have no history of novel influenza H1N1 2009 infection in latest 3 months or novel influenza H1N1 2009 vaccination. This is a randomized study in healthy males and non-pregnant females, aged 20 years and older. All subjects will be stratified into 1 dose group (15mcg per dose), and will receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. On Day 0, Day 10, Day 21, Day 28, Day 35 and Day 42 after first vaccination (Day 0), the immunogenicity testing will be manipulated. The antibody response of immunogenicity testing will be hemagglutination inhibiting (HAI) on serum. The T-cell response will be interferon-gamma ELISPOT assay and Tetramer staining using PBMCs.

Conditions

  • Human Influenza

Interventions

BIOLOGICAL

split-virion, H1N1 vaccine of 15 μg

split-virion inactivated S-OIV vaccine of 15 μg on day 0 and 21.

Sponsors & Collaborators

  • Hualan Biological Bacterin Co. Ltd.

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    collaborator NETWORK

  • Chinese Academy of Sciences

    lead OTHER_GOV

Principal Investigators

  • George Fu Gao, Ph.D. · CAS Key Laboratory of Pathogenic Microbiology and Immunology,Institute of microbiology, Chinese Academy of Sciences

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-04-30
Completion
2010-08-31

Countries

  • China

Study Locations

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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 NCT01096225 on ClinicalTrials.gov