Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine
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|ClinicalTrials.gov Identifier: NCT02229357|
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : April 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Avian Influenza||Biological: OrniFlu® inactivated vaccine||Phase 2|
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 blind placebo-controlled study Protocol No.: GPO AVIAN FLU Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University in February to May 2013.
A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and 20 received placebo (control group) in the previous study will be asked to return to the clinic to receive a single dose of an inactivated H5 influenza vaccine.
Total foloww up is 90 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
|Experimental: OrniFlu® inactivated vaccine||
Biological: OrniFlu® inactivated vaccine
All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229357
|Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Punnee Pitisuttithum||Mahidol University|