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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

NCT01666262 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2012-08-16

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

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

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

OTHER

Placebo:Stabilizer

5% sucrose

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Completion
2012-01-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01666262 on ClinicalTrials.gov