NCT01656356

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

3 months

First QC Date

July 25, 2012

Last Update Submit

August 7, 2012

Conditions

Preventive Avian Flu

Keywords

Avian FluH5N2

Study Arms (2)

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

ACTIVE COMPARATOR
Biological: Avian Flu Vaccine

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

Avian Flu VaccineBIOLOGICAL
A/17/turkey/Turkey/05/133 (H5N2)
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Tropical Medicine

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2012

First Posted

August 3, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

TH(1)