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Phase I Safety and Immunogenicity of Live Attenuated Influenza H5 Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2) in Healthy Thai Volunteers

NCT ID: NCT01656356

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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The purpose of this study is to evaluate safety and reactogenicity of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO, in Thailand to previously healthy Thais.

Detailed Description

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It is a phase I randomized placebo controlled trial (vaccine and placebo ratio of 2:1). A phase II study is planned to be conducted following review of results of this phase.

Phase I: It is a double blind randomized placebo controlled trial involving 24 participants age 18-49 years (16 will receive vaccines and 8 will receive placebo). All will be admitted in the isolation ward for 10-14 days after each immunization mainly for safety assessment. Two doses of live attenuated influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) will be given by intranasal route 21 days apart. Each group of 4 participants will be immunized at a time at 30-60 mins interval. All participants will be followed 21 days after each immunization. Total follow up is 60 day.

Conditions

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Preventive Avian Flu

Keywords

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Avian Flu H5N2

Study Groups

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A/17/turkey/Turkey/05/133 (H5N2)

Group Type ACTIVE_COMPARATOR

Avian Flu Vaccine

Intervention Type BIOLOGICAL

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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Avian Flu Vaccine

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Age 18-49 years old
* Having Thai ID card or equivalent
* Are seronegative to the specific H5 influenza virus determined by antibody titer less than 1:40 by HAI test to the corresponding antigen.
* Anti HIV - Negative
* All hematology \& biochemistry and urine analysis are within normal range or of no clinical significance (not more than 1.5 times of normal value)
* Able to read and write and sign written informed consent.

Exclusion Criteria

* Known history of egg allergy
* Having had recently influenza infection confirmed as H5
* History of bronchial asthma
* History of chronic lung diseases
* History of chronic rhinitis
* History of immunodeficiency state
* History of immunosuppression
* History of heavy smoking (more than 5 rolls per day)
* History of alcoholic (pure drink 200 ml per day)
* Acute infectious and noninfectious diseases (within 2 weeks)
* Exacerbation of chronic diseases or cancer or HIV positives
* Anamnestic leukocytosis, hepatitis B and C positives
* The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
* Participation in other research study or stop participant less than 1 month
* Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
* Any concomitant medication with Aspirin
* The volunteers who have family members with immunodeficiency
* Poultry workers
* Have undertaken international travel within the one week prior to immunization
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Punnee Pitisuttithum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Tropical Medicine

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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GPO AVIAN FLU Vaccine-V02

Identifier Type: -

Identifier Source: org_study_id