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

Mahidol University

Status and phase: Enrolling; Phase 3

Conditions: Influenza

Treatments: Biological: Licensed influenza vaccine; Biological: GPO Tri Fluvac vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04548518

Tri Fluvac Vaccine in Elderly

Details and patient eligibility

About

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).

Full 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).

Enrollment: 816 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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816 participants in 2 patient groups

GPO Tri Fluvac vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: GPO Tri Fluvac vaccine

Licensed Influenza vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: Licensed influenza vaccine