NCT01841918

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 31, 2018

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

January 29, 2013

Last Update Submit

January 30, 2018

Conditions

Influenza Due to Influenza A Virus Subtype H5N2

Outcome Measures

Primary Outcomes (1)

  • Phase II safety and immunogenicity of live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 (H5N2) in healthy Thai volunteers

    within 60 days after screening

Study Arms (2)

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

EXPERIMENTAL

100 participants will be admitted in the isolation ward for 5 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 28 days apart and will be followed for the total of 60 days.

Biological: Avian Flu Vaccine

Placebo

PLACEBO COMPARATOR

50 participants will be admitted in the isolation ward for 5 days after each administered placebo mainly for safety assessment. Two doses placebo will be given by intranasal route 28 days apart and will be followed for the total of 60 days.

Biological: Avian Flu Vaccine

Interventions

Avian Flu VaccineBIOLOGICAL
A/17/turkey/Turkey/05/133 (H5N2)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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Tropical Medicine

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Pitisuttithum P, Boonnak K, Chamnanchanunt S, Puthavathana P, Luvira V, Lerdsamran H, Kaewkungwal J, Lawpoolsri S, Thanachartwet V, Silachamroon U, Masamae W, Schuetz A, Wirachwong P, Thirapakpoomanunt S, Rudenko L, Sparrow E, Friede M, Kieny MP. Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2017 Aug;17(8):833-842. doi: 10.1016/S1473-3099(17)30240-2. Epub 2017 May 19.

    PMID: 28533093DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2013

First Posted

April 29, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

January 31, 2018

Record last verified: 2017-07

Locations

TH(1)