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

October 7, 2024 updated by: Punnee Pitisuttithum, Mahidol University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 18 years and above
  2. Having Thai ID card or equivalent
  3. Able to read and provide written informed consent prior to performance of any study-specific procedure
  4. 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.
  5. 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:

  1. Known history of egg allergy
  2. Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrollment to the trial
  3. Vaccination against influenza in the past 6 months preceding enrollment to the trial
  4. History of bronchial asthma, chronic lung diseases, chronic rhinitis
  5. History of immunodeficiency state
  6. History of immunosuppression < 6 months prior to immunization
  7. History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal)
  8. Acute infectious with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial
  9. The participants who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment
  10. Participation in other research study
  11. Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
  12. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  13. 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
  14. Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.
  15. Any test for HIV, HBsAg, Hep C antibody shows positive results with clinically significance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TetraFluvac TF vaccine
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.
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 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.
Active Comparator: Vaxigrip vaccine
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.
Biological: Vaxigrip vaccine

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and percentage of Solicited local adverse events post-vaccination.
Time Frame: 30-minutes after 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.
Time Frame: day 1
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.
Time Frame: day 2
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.
Time Frame: day 3
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
day 3
Number and percentage of Solicited systemic adverse events post-vaccination.
Time Frame: 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)
30-minutes after vaccination
Number and percentage of Solicited systemic adverse events post-vaccination.
Time Frame: day 1
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.
Time Frame: day 2
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.
Time Frame: day 3
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 participants with unsolicited adverse events
Time Frame: 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
day 0 up to day 90
Number and percentage of participants with AESI
Time Frame: day 0 up to day 90
Number and percentage of participants with AESI
day 0 up to day 90
Number and percentage of participants with Medically-Attended Adverse Event
Time Frame: day 0 up to day 90
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
Time Frame: day 0 up to day 90
Number and percentage of participants with Serious Adverse Event
day 0 up to day 90
Number and percentage of Solicited local adverse events post-vaccination.
Time Frame: day 4
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.
Time Frame: day 5
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
day 5
Number and percentage of Solicited local adverse events post-vaccination.
Time Frame: day 6
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.
Time Frame: day 7
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.
Time Frame: day 4
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.
Time Frame: day 5
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.
Time Frame: day 6
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.
Time Frame: day 7
Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea)
day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antihemagglutinin antibody titer changed from baseline.
Time Frame: 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.
day 28
Antihemagglutinin antibody titer changed from baseline.
Time Frame: 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.
day 60
Antihemagglutinin antibody titer changed from baseline.
Time Frame: 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 90
Geometric mean of immune response changed from baseline
Time Frame: 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
day 28
Geometric mean of immune response changed from baseline
Time Frame: 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
day 60
Geometric mean of immune response changed from baseline
Time Frame: 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
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Government Pharmaceutical Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: PUNNEE PITISUTTITHUM, M.D, Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TetraFluvac TF vaccine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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