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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 April 2015 |
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Main ID: |
NCT02229357 |
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Date of registration:
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28/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine
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Scientific title:
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Evaluation of Priming Effects by Pandemic Live Attenuated Influenza Vaccine (LAIV Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2)) on the Subsequent Response to Inactivated H5N1 Vaccine in Healthy Thai Volunteers: A Non-Randomized, Open Label Study |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02229357 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Punnee Pitisuttithum |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Avian Influenza
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Intervention(s)
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Biological: OrniFlu® inactivated vaccine
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Primary Outcome(s)
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Proportion of subjects exhibiting sero-responses in each of the assays (HAI, microneutralization) in the prime-boost and the control groups.
[Time Frame: 12 Months]
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Secondary Outcome(s)
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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.
[Time Frame: 12 Month]
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Secondary ID(s)
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GPO Avian Flu Vaccine-Boost
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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