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

NCT05895955 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: TetraFluvac TF vaccine
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; GPO TetraFluvac Vaccine; TetraFluvac Vaccine; Thais; Thailand; Vaxigrip vaccine; Influenza vaccine

Outcome Measures

Primary Outcomes (20)

• 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

• 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

Secondary Outcomes (6)

• Antihemagglutinin antibody titer changed from baseline.

  day 28

• Antihemagglutinin antibody titer changed from baseline.

  day 60

• Antihemagglutinin antibody titer changed from baseline.

  day 90

• Geometric mean of immune response changed from baseline

  day 28

• Geometric mean of immune response changed from baseline

  day 60

Study Arms (2)

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.

Biological: TetraFluvac TF vaccine

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.

Biological: Vaxigrip vaccine

Interventions

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.

TetraFluvac TF vaccine

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.

Vaxigrip vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• The Government Pharmaceutical Organization: collaborator

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• PUNNEE PITISUTTITHUM, M.D

  Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double (Participant, Investigator)

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 9, 2023
• Study Start: November 4, 2023
• Primary Completion: March 25, 2024
• Study Completion: July 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)