Clinical trial NCT04548518: Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Elderly
Official title: A Phase III Double Blinded, Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Subjects Aged 65 Years and Above
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza Vaccine
Tri Fluvac vaccine
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: The Government Pharmaceutical Organization
First posted: 2020-09-14
Enrollment: 816
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-inferiority double-blinded, randomized, controlled trial
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Number and percentage of seroconverted participants at 28 days post vaccination
timeFrame: 28 days
measure: Geometric Mean Titers (GMTs) of serum HI antibodies at baseline (Day 0) and post- vaccination (Day 28).
timeFrame: 28 days
Secondary outcomes:
measure: Number and percentage of participants with solicited local and systemic adverse events. post vaccination
timeFrame: 30 minutes, Day 1-3 post-vaccination
measure: Number and percentage of participants with unsolicited adverse event.
timeFrame: 180 days
measure: Number and percentage of participants with serious adverse event.
timeFrame: 180 days
measure: Number and percentage of participants with HI response with and without pre-existing HI antibody.
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Study officials:
affiliation: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
name: Punnee Pitisuttithum
role: PRINCIPAL_INVESTIGATOR
References: