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Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

NCT02894840 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2020-03-17

Study results available
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Summary

The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.

Conditions

Interventions

BIOLOGICAL

an inactivated influenza vaccine

The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

OTHER

Placebo

The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

Sponsors & Collaborators

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • World Health Organization

    collaborator OTHER

  • Mahidol University

    lead OTHER

Principal Investigators

  • Punnee Pitisuttithum, Prof. · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-07-31
Completion
2016-11-30

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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 NCT02894840 on ClinicalTrials.gov