Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
This study has been completed.
Sponsor:
Mahidol University
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University
ClinicalTrials.gov Identifier:
NCT01666262
First received: January 11, 2010
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: Vaccine A/17/CA/2009/38 (H1N1) Other: Placebo:Stabilizer |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by Mahidol University:
Primary Outcome Measures:
- Systemic reaction and local reaction (vital sign, temperature) [ Time Frame: 11/2 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Humoral immune response [ Time Frame: 11/2 year ] [ Designated as safety issue: No ]
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.
| Enrollment: | 363 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2012 |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Other: Placebo:Stabilizer
5% sucrose
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 9 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666262
Locations
| Thailand | |
| Faculty of Tropical Medicine, Mahidol University | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
Mahidol University
Investigators
| Principal Investigator: | Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad | Mahidol University |
More Information
No publications provided
| Responsible Party: | Punnee Pitisuttithum, Professor, Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01666262 History of Changes |
| Other Study ID Numbers: | GPO FLU VACCINE-01 |
| Study First Received: | January 11, 2010 |
| Last Updated: | August 10, 2012 |
| Health Authority: | Thailand: Ethical Committee Thailand: Food and Drug Administration |
Keywords provided by Mahidol University:
|
FLU H1N1 GPO PLAIV |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013