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

NCT04548518 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 816

Last updated 2022-08-25

No results posted yet for this study

Summary

The study is aim to evaluate the Immunogenicity 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

Each dose of Tri Fluvac contains a total of 45 micrograms (μg) hemagglutinin (HA) per 0.5 ml dose (15 μg HA per strain per dose), to be administered by intramuscular (IM) injection. Tri Fluvac is manufactured and formulated into a multiple-dose vial vaccine (2 doses) using thimerosal at relatively low concentration as preservative (≤ 5.75 μg mercury/ dose). Each 0.5 ml dose of vaccine may contain residual amounts of ovalbumin (≤ 1.0μg), formaldehyde (≤ 100μg), tween 80 (≤ 0.9μg), triton x-100 (≤0.05μg) and gentamicin (≤0.075μg).

BIOLOGICAL

Licensed influenza vaccine

The comparator licensed influenza vaccine is a seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020

Sponsors & Collaborators

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • Mahidol University

    lead OTHER

Principal Investigators

  • Punnee Pitisuttithum · Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT04548518 on ClinicalTrials.gov