Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais
Study Details
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 year and above over 90 days post-injection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 1/Phase 2 |
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 commercially available seasonal quadrivalent vaccine-split subunit vaccine with the strains 2023)
Phase II of the study A total of 300 healthy participants will be enrolled (2:1 ratio, 200 TetraFluvac TF vaccine and 100 commercially available seasonal quadrivalent vaccine-split subunit vaccine with the strains 2023) One dose of the TetraFluvac TF or commercially available seasonal quadrivalent vaccine-split subunit vaccine with the strains 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 will be collected on Day 0 prior to vaccination, Day 28, Day 60, and day 90.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TetraFluvac TF vaccine 20 participants in phase I study and 200 participants in phase II study will receive a 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. |
Biological: TetraFluvac TF vaccine
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 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.
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| Active Comparator: seasonal quadrivalent vaccine-split subunit vaccine with the strains 2023 20 participants in phase I study and 100 participants in phase II study will receive a single dose of 0.5 ml of commercially available seasonal quadrivalent vaccine-split subunit vaccine with the strains 2023 will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
Biological: Seasonal quadrivalent vaccine-split subunit vaccine with the strains 2023
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-like virus and B/Phuket/3073/2013-like virus]
Each dose of seasonal quadrivalent vaccine-split subunit vaccine with the strains 2023 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.
|
Outcome Measures
Primary Outcome Measures
- Number and percentage of Solicited local adverse events post-vaccination. [30-minutes after 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. [day 1]
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. [day 2]
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. [day 3]
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. [30-minutes after 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. [day 1]
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. [day 2]
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. [day 3]
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 [day 0 up to day 90]
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 [day 0 up to day 90]
Number and percentage of participants with AESI
- Number and percentage of participants with Medically-Attended Adverse Event [day 0 up to day 90]
Number and percentage of participants with Medically-Attended Adverse Event
- Number and percentage of participants with Serious Adverse Event [day 0 up to day 90]
Number and percentage of participants with Serious Adverse Event
Secondary Outcome Measures
- Antihemagglutinin antibody titer changed from baseline. [day 28]
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. [day 60]
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. [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.
- Geometric mean of immune response changed from baseline [day 28]
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 [day 60]
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 [day 90]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 years and above
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Having Thai ID card or equivalent
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Able to read and provide written informed consent prior to performance of any study-specific procedure
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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.
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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:
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Known history of egg allergy
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Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrollment to the trial
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Vaccination against influenza in the past 6 months preceding enrollment to the trial
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History of bronchial asthma, chronic lung diseases, chronic rhinitis
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History of immunodeficiency state
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History of immunosuppression < 6 months prior to immunization
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History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal)
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Acute infectious with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial
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The participants who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment
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Participation in other research study
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Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
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Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
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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
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Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- Mahidol University
- The Government Pharmaceutical Organization (GPO) Bangkok, Thailand
Investigators
- Principal Investigator: PUNNEE PITISUTTITHUM, M.D, Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TetraFluvac TF vaccine