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| Name | Class |
|---|---|
| The Government Pharmaceutical Organization | OTHER_GOV |
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The study is aim to evaluate the safety and immunogenicity of one dose TetraFluvac TF vaccine (15 μg HA per strain per dose) of the GPO seasonal quadrivalent inactivated split virion influenza vaccine in healthy adults aged 18 years and above over 90 days post-injection.
This is a double blind randomized study consisting of two phases - Phase I and Phase II.
Phase I of the study A total of 40 healthy participants aged 18 years and above will be enrolled (1:1 ratio, 20 TetraFluvac TF vaccine and 20 Vaxigrip vaccine (Commercially available seasonal quadrivalent split, manufactured by Sanofi Pasteur, Ltd. France)
Phase II of the study A total of 250 healthy participants will be enrolled (4:1 ratio, 200 TetraFluvac TF vaccine and 50 Vaxigrip vaccine (Commercially available seasonal quadrivalent split , manufactured by Sanofi Pasteur, Ltd. France) One dose of the TetraFluvac TF or Commercially available seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 will be given 0.5 ml by intramuscular route.
Total follow-up is 90 days.
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination participants will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization.
Blood specimens for immune response will be collected on Day 0 prior to vaccination, Day 28, Day 60, and day 90.
Blood specimen for safety will be collected Day 28 for participants Phase I only for clinical hematology and chemistry.
A DSMB, composed of at least three independent members with expertise in vaccine clinical trials, will be convened to provide additional safety oversight. In Phase I, the DSMB will meet to review all safety profiles of 28 days after immunization. After completing Day 7 of phase I with no safety concern, the screening for phase II can be started. However, the vaccination of phase II will occur after the recommendation of the DSMB.There should be no safety concerns from DSMB meeting for continue Phase II. In Phase II, the DSMB will meet to review all safety profiles after vaccination of 100 participants for completion of Phase II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TetraFluvac TF vaccine | Experimental | 20 participants in phase I study and 200 participants in phase II study will receive a prefilled single dose of 0.5 ml of TetraFluvac TF vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
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| Vaxigrip vaccine | Active Comparator | 20 participants in phase I study and 50 participants in phase II study will receive a prefilled single dose of 0.5 ml Vaxigrip vaccine (Commercially available seasonal quadrivalent split, manufactured by Sanofi Pasteur, Ltd. France) will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TetraFluvac TF vaccine | Biological | The vaccine is a seasonal quadrivalent inactivated split virion influenza vaccine [A/Sydney/5/2021(H1N1) pdm09-like virus and A/Darwin/9/2021 (H3N2)-like virus and B/Austria/1359417/2021 (B/Victoria Lineage)-like virus and B/Phuket/3073/2013 (B/Yamagata lineage)-like virus] produced by The Government Pharmaceutical Organization (GPO), Thailand. Each prefilled dose of TetraFluvac TF contains a total of 60 micrograms (μg) hemagglutinin (HA) per 0.5 ml dose (15 μg HA per strain per dose), to be administered by intramuscular (IM) injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of Solicited local adverse events post-vaccination. | Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) | 30-minutes after vaccination |
| Number and percentage of Solicited local adverse events post-vaccination. | Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) | day 1 |
| Number and percentage of Solicited local adverse events post-vaccination. | Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) | day 2 |
| Number and percentage of Solicited local adverse events post-vaccination. | Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) | day 3 |
| Number and percentage of Solicited local adverse events post-vaccination. | Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) | day 4 |
| Number and percentage of Solicited local adverse events post-vaccination. | Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) | day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Antihemagglutinin antibody titer changed from baseline. | Seroconversion is defined as a 4-fold rise in HI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40. | day 28 |
| Antihemagglutinin antibody titer changed from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PUNNEE PITISUTTITHUM, M.D | 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 | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Double (Participant, Investigator)
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Unblinded study staff, including the site pharmacist, will be responsible for preparing study products (in accordance with the randomly determined assignment), and handling all drug accountability procedures. These personnel will not participate in the other aspects of the clinical trial, to help ensure the integrity of the blind at the site. Unblinded staff will retrieve a participant's randomization assignment after being informed by the PI or designee that a participant is eligible for randomization. They will provide the prefilled 0.5 ml dose of study product based on the participant's randomization
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| Vaxigrip vaccine | Biological | Vaxigrip vaccine is commercially available seasonal quadrivalent inactivated split virion influenza vaccine [A/Sydney/5/2021(H1N1) pdm09-like strain and A/Darwin/9/2021 (H3N2)-like strain and B/Austria/1359417/2021-like strain and B/Phuket/3073/2013-like strain, manufactured by Sanofi Pasteur, Ltd. France. Each prefilled dose of Vaxigrip vaccine contains a total of 60 micrograms (μg) hemagglutinin (HA) per 0.5 ml dose (15 μg HA per strain per dose), to be administered by intramuscular (IM) injection.](streamdown:incomplete-link) |
|
| Number and percentage of Solicited local adverse events post-vaccination. |
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) |
| day 6 |
| Number and percentage of Solicited local adverse events post-vaccination. | Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration) | day 7 |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | 30-minutes after vaccination |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | day 1 |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | day 2 |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | day 3 |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | day 4 |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | day 5 |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | day 6 |
| Number and percentage of Solicited systemic adverse events post-vaccination. | Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea) | day 7 |
| Number and percentage of participants with unsolicited adverse events | All unsolicited adverse events during 90 days will be analysed in terms of number and percentage and relationship to study vaccine Number and percentage of participants with unsolicited adverse events | day 0 up to day 90 |
| Number and percentage of participants with AESI | Number and percentage of participants with AESI | day 0 up to day 90 |
| Number and percentage of participants with Medically-Attended Adverse Event | Number and percentage of participants with Medically-Attended Adverse Event | day 0 up to day 90 |
| Number and percentage of participants with Serious Adverse Event | Number and percentage of participants with Serious Adverse Event | day 0 up to day 90 |
Seroconversion is defined as a 4-fold rise in HI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40. |
| day 60 |
| Antihemagglutinin antibody titer changed from baseline. | Seroconversion is defined as a 4-fold rise in HI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40. | day 90 |
| Geometric mean of immune response changed from baseline | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment | day 28 |
| Geometric mean of immune response changed from baseline | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment | day 60 |
| Geometric mean of immune response changed from baseline | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment | day 90 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |