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Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais

NCT ID: NCT01666262

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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FLU H1N1 GPO PLAIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A/17/CA/2009/38 (H1N1)

Group Type EXPERIMENTAL

Vaccine A/17/CA/2009/38 (H1N1)

Intervention Type BIOLOGICAL

Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)

Stabilizer

Group Type PLACEBO_COMPARATOR

Placebo:Stabilizer

Intervention Type OTHER

5% sucrose

Interventions

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Vaccine A/17/CA/2009/38 (H1N1)

Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)

Intervention Type BIOLOGICAL

Placebo:Stabilizer

5% sucrose

Intervention Type OTHER

Other Intervention Names

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GPO Flu Vaccine-01

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Punnee Pitisuttithum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Tropical Medicine, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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GPO FLU VACCINE-01

Identifier Type: -

Identifier Source: org_study_id