Status:
COMPLETED
Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
The Government Pharmaceutical Organization
World Health Organization
Conditions:
Avian Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
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
Detailed Description
It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine (produced by Microgen Russia) which will be given to healthy adult volunteers who participated in a double ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Poultry workers
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02229357
Start Date
June 1 2014
End Date
September 1 2014
Last Update
April 9 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, Thailand, 10400