Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
1 other identifier
interventional
363
1 country
1
Brief Summary
The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2009
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedAugust 16, 2012
August 1, 2012
January 11, 2010
August 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systemic reaction and local reaction (vital sign, temperature)
11/2 year
Secondary Outcomes (1)
Humoral immune response
11/2 year
Study Arms (2)
A/17/CA/2009/38 (H1N1)
EXPERIMENTALStabilizer
PLACEBO COMPARATORInterventions
Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)
Eligibility Criteria
You may qualify if:
- Healthy
- Age 9 - \>49 years old
- Having Thai ID card or equivalent
- Are seronegative to the specific H1N1 influenza virus determined by antibody titer less than 1:10 by HAI test to the corresponding antigen
- Anti HIV - Negative
- All hematology \& biochemistry within normal range
- 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 H1N1 (indeed all other types if Influenza and vaccination with seasonal vaccine will not interfere)
- History of bronchial asthma
- History of chronic lung diseases
- History of chronic rhinitis
- History of immunodeficiency state
- History of immunosuppression
- Acute infectious and noninfectious diseases (within 2 weeks)
- Exacerbation of chronic diseases or cancer or HIV positives
- Anamnestic leukocytosis, hepatitis B and C 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
- Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
- Any concomitant medication with Aspirin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 11, 2010
First Posted
August 16, 2012
Study Start
September 1, 2009
Study Completion
January 1, 2012
Last Updated
August 16, 2012
Record last verified: 2012-08