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

NCT ID: NCT04548518

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 816 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2023-12-31

Brief 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).

Detailed Description

This is a phase III, non-inferiority double-blinded, randomized, controlled trial of 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).

A total of about 816 healthy Thai male and female adult volunteers ≥ 65 years of age; 408 participants will be randomized to receive the GPO Tri Fluvac and 408 will receive an active comparator (a 1:1 ratio).

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GPO Tri Fluvac vaccine

408 participants will receive a seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020 (consisting of A/Brisbane/02/2018 (H1N1)pdm-09-like virus, A/South Australia/34/2019 (H3N2)-like virus, and B/Washington/02/2019-like (B/Victoria lineage) virus) produced by the Government Pharmaceutical Organization (GPO), Thailand. The vaccine to be administered by intramuscular (IM) injection.

Group Type: ACTIVE_COMPARATOR

GPO Tri Fluvac vaccine

Intervention Type: BIOLOGICAL

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).

Licensed Influenza vaccine

408 will receive a Licensed Influenza vaccine (seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020 (consisting of A/Brisbane/02/2018 (H1N1) pdm-09-like virus, A/South Australia/34/2019 (H3N2)-like virus, and B/Washington/02/2019-like (B/Victoria lineage) virus) 0.5 mL administered intramuscularly (IM) in the deltoid muscle of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

Licensed influenza vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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).

Intervention Type: BIOLOGICAL

Licensed influenza vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 65 years old on the day of screening, having Thai ID card or equivalent
• Able to read and write in Thai and sign written informed consent form
• Able to attend all scheduled visits and to comply with all trial procedures.
• Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable, under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination.

Exclusion Criteria

• Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
• Hypersensitivity after previous administration of any vaccine.
• Having a history of H1N1, H3N2 or FluB infection within 3 months preceding enrollment to the trial
• Vaccination against influenza in the past 6 months preceding enrollment to the trial
• Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 28 visit.
• History of bronchial asthma, chronic lung diseases, chronic rhinitis
• History of immunodeficiency state
• History of immunosuppression < 6 months prior to immunization
• History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. egg proteins, gentamicin or thimerosal)
• History of Guillain-Barré Syndrome or cerebrovascular events
• Having acute infection with fever > 38 degree Celsius or noninfectious diseases (within 72 hours) preceding enrollment in the trial
• Volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the trial or planned receipt of such products prior to the Day 28 visit.
• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
• Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine
• Study site employees who are involved in the protocol and/or may have direct access to study related area

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Government Pharmaceutical Organization

OTHER_GOV

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Punnee Pitisuttithum

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Punnee Pitisuttithum

Role: PRINCIPAL_INVESTIGATOR

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,

Locations

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Punnee Pitisuttithum

Role: CONTACT

punnee.pit@mahidol.ac.th

(662) 6435599

Facility Contacts

Punnee Pitisuttithum

Role: primary

punnee.pit@mahidol.ac.th

6626435599

Other Identifiers

Tri Fluvac Vaccine in Elderly

Identifier Type: -

Identifier Source: org_study_id