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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
290
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.
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.
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: day 5
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)
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Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: day 0 up to day 90
Number and percentage of participants with AESI
Number and percentage of participants with AESI
Time frame: 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
Time frame: day 0 up to day 90
Number and percentage of participants with Serious Adverse Event
Number and percentage of participants with Serious Adverse Event
Time frame: day 0 up to day 90
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.
Time frame: day 28
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day 90