Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
|ClinicalTrials.gov Identifier: NCT01666262|
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : August 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: Vaccine A/17/CA/2009/38 (H1N1) Other: Placebo:Stabilizer||Phase 1 Phase 2|
Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.
Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||363 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais|
|Study Start Date :||September 2009|
|Study Completion Date :||January 2012|
|Experimental: A/17/CA/2009/38 (H1N1)||
Biological: Vaccine A/17/CA/2009/38 (H1N1)
Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)
Other Name: GPO Flu Vaccine-01
|Placebo Comparator: Stabilizer||
- Systemic reaction and local reaction (vital sign, temperature) [ Time Frame: 11/2 year ]
- Humoral immune response [ Time Frame: 11/2 year ]
Peak immunogenicity blood specimen and nasal washing for accessing immune response IgA.
Nasal swab on D2, D3, D5, D7 after immunization. Blood for ASC assay at D0 (baseline) and D7 after each dose of vaccine.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666262
|Faculty of Tropical Medicine, Mahidol University|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad||Mahidol University|