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Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais

Primary Purpose

Influenza

Status
Not yet recruiting
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
TetraFluvac TF vaccine
Vaxigrip vaccine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, GPO TetraFluvac Vaccine, TetraFluvac Vaccine, Thais, Thailand, Vaxigrip vaccine, Influenza vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 18 years and above Having Thai ID card or equivalent Able to read and provide written informed consent prior to performance of any study-specific procedure Healthy as defined by no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination) Exclusion Criteria: Known history of egg allergy Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrollment to the trial Vaccination against influenza in the past 6 months preceding enrollment to the trial 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. gentamicin or thimerosal) Acute infectious with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial The participants who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment Participation in other research study Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding 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 Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site. Any test for HIV, HBsAg, Hep C antibody shows positive results with clinically significance

Sites / Locations

  • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TetraFluvac TF vaccine

Vaxigrip vaccine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Number and percentage of participants with AESI
Number and percentage of participants with AESI
Number and percentage of participants with Medically-Attended Adverse Event
Number and percentage of participants with Medically-Attended Adverse Event
Number and percentage of participants with Serious Adverse Event
Number and percentage of participants with Serious Adverse Event

Secondary Outcome Measures

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.
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.
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.
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
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
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

Full Information

First Posted
May 5, 2023
Last Updated
September 7, 2023
Sponsor
Mahidol University
Collaborators
The Government Pharmaceutical Organization (GPO) Bangkok, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT05895955
Brief Title
Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais
Official Title
A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 3, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
The Government Pharmaceutical Organization (GPO) Bangkok, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, GPO TetraFluvac Vaccine, TetraFluvac Vaccine, Thais, Thailand, Vaxigrip vaccine, Influenza vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double (Participant, Investigator)
Masking
ParticipantInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TetraFluvac TF vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
Vaxigrip vaccine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
TetraFluvac TF vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Vaxigrip vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
30-minutes after vaccination
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
day 1
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
day 2
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
day 3
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
day 4
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
day 5
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
day 6
Title
Number and percentage of Solicited local adverse events post-vaccination.
Description
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Time Frame
day 7
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of Solicited systemic adverse events post-vaccination.
Description
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
Title
Number and percentage of participants with unsolicited adverse events
Description
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
Title
Number and percentage of participants with AESI
Description
Number and percentage of participants with AESI
Time Frame
day 0 up to day 90
Title
Number and percentage of participants with Medically-Attended Adverse Event
Description
Number and percentage of participants with Medically-Attended Adverse Event
Time Frame
day 0 up to day 90
Title
Number and percentage of participants with Serious Adverse Event
Description
Number and percentage of participants with Serious Adverse Event
Time Frame
day 0 up to day 90
Secondary Outcome Measure Information:
Title
Antihemagglutinin antibody titer changed from baseline.
Description
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
Title
Antihemagglutinin antibody titer changed from baseline.
Description
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
Title
Antihemagglutinin antibody titer changed from baseline.
Description
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
Title
Geometric mean of immune response changed from baseline
Description
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
Title
Geometric mean of immune response changed from baseline
Description
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
Title
Geometric mean of immune response changed from baseline
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 years and above Having Thai ID card or equivalent Able to read and provide written informed consent prior to performance of any study-specific procedure Healthy as defined by no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination) Exclusion Criteria: Known history of egg allergy Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrollment to the trial Vaccination against influenza in the past 6 months preceding enrollment to the trial 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. gentamicin or thimerosal) Acute infectious with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial The participants who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment Participation in other research study Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding 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 Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site. Any test for HIV, HBsAg, Hep C antibody shows positive results with clinically significance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WEERAPONG PHUMRATANAPRAPIN, M.D
Phone
081- 646 6326
Email
weerapong.phu@mahidol.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
PUNNEE PITISUTTITHUM, M.D
Phone
081-829 4906
Email
punnee.pit@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PUNNEE PITISUTTITHUM, M.D
Organizational Affiliation
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Punnee Pitisuttithum, MD
Phone
662-643-5599
Email
punnee.pit@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
WEERAPONG PHUMRATANAPRAPIN, MD
First Name & Middle Initial & Last Name & Degree
Sant Muangnoicharoen, MD
First Name & Middle Initial & Last Name & Degree
Viravarn Luvira, MD
First Name & Middle Initial & Last Name & Degree
Arom Pitisuthitham, MD
First Name & Middle Initial & Last Name & Degree
Supitcha Kamolratanakul, MD
First Name & Middle Initial & Last Name & Degree
Benjaluck Phonrat, M.Sc.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais

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