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Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

NCT03390166 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 945

Last updated 2020-04-14

Study results available
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Summary

The study is aim to evaluate the immunogenicity and safety with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine

Conditions

Interventions

BIOLOGICAL

GPO Tri Fluvac vaccine

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

BIOLOGICAL

Licensed influenza vaccine

The comparator licensed influenza vaccine 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
2017-07-24
Primary Completion
2018-03-31
Completion
2019-02-12

Countries

  • Thailand

Study Locations

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Entities

Diseases
Companies

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 NCT03390166 on ClinicalTrials.gov