Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Government Pharmaceutical Organization | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPO Tri Fluvac vaccine | Active Comparator | 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. |
|
| Licensed Influenza vaccine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GPO Tri Fluvac vaccine | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of seroconverted participants at 28 days post vaccination | seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria:
| 28 days |
| Geometric Mean Titers (GMTs) of serum HI antibodies at baseline (Day 0) and post- vaccination (Day 28). | Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 28) for each of the three vaccine antigens. GMTs will be calculated with 95% CI. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants with solicited local and systemic adverse events. post vaccination | Solicited local adverse events including redness/erythema, swelling/induration, pain, and limitation of arm movement. Solicited systemic adverse events including fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, and headache. | 30 minutes, Day 1-3 post-vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Punnee Pitisuttithum | Contact | (662) 6435599 | punnee.pit@mahidol.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Punnee Pitisuttithum | Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University | Recruiting | Bangkok | Thailand |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
non-inferiority double-blinded, randomized, controlled trial
Not provided
Not provided
double blinded
|
| Licensed influenza vaccine | Biological | The comparator licensed influenza vaccine is a seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020 |
|
| Number and percentage of participants with unsolicited adverse event. | Number and percentage of participants with unsolicited adverse event occuring during the entire study period (Days 0-180) | 180 days |
| Number and percentage of participants with serious adverse event. | Number and percentage of participants with serious adverse event occuring during the entire study period (Days 0-180) | 180 days |
| Number and percentage of participants with HI response with and without pre-existing HI antibody. | Number and percentage of participants with a HI antibody titer ≥1:40 (seroprotective level) to each of the three vaccine antigens. | 28 days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |