NCT02229357

Brief Summary

This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

August 28, 2014

Last Update Submit

April 8, 2015

Conditions

Avian Influenza

Keywords

H5N2 Vaccine

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.

    12 Months

Secondary Outcomes (1)

  • Post-vaccination injection site and systemic reactogenicity and adverse events to the H5 inactivated influenza vaccine in subjects previously primed with LAIV H5N2 and in naïve subjects.

    12 Month

Study Arms (1)

OrniFlu® inactivated vaccine

EXPERIMENTAL
Biological: OrniFlu® inactivated vaccine

Interventions

OrniFlu® inactivated vaccineBIOLOGICAL

All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays

OrniFlu® inactivated vaccine

Eligibility Criteria

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

You may qualify if:

  • Participated in the Phase II study Protocol No.: GPO AVIAN FLU Vaccine-V02-2
  • Healthy
  • Age 18-49 years old
  • Having Thai ID card or equivalent
  • Anti HIV - Negative
  • All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
  • 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
  • Receiving other vaccination against H5N1
  • History of bronchial asthma
  • History of chronic lung diseases
  • History of chronic rhinitis
  • History of immunodeficiency state
  • History of immunosuppression\< 6 months prior to immunization
  • History of heavy smoking (more than 5 packs per day)
  • History of alcoholic (pure drink 200 ml per day)
  • Acute infectious and noninfectious diseases (within 2 weeks)
  • HIV 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, 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

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal Diseases

Study Officials

  • Punnee Pitisuttithum

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 1, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

TH(1)