A Phase II/III Double Blinded, Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Subjects Aged 18-49 Years
Phase: PHASE2
Conditions: Influenza
Sponsor: Mahidol University

 
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt
Release Date: March 5, 2019
ClinicalTrials.gov ID: NCT03390166
 
Study Identification
Unique Protocol ID: Tri Fluvac Vaccine phase 2/3
Brief Title: Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated
Influenza Vaccine in Healthy Thai Adults
Official Title: A Phase II/III Double Blinded, Randomized, Controlled, Non-inferiority Trial to
Evaluate the Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent
Inactivated Split Virion Influenza Vaccine, in Healthy Thai Subjects Aged 18-49
Years
Secondary IDs:
Study Status
Record Verification: March 2019
Overall Status: Completed
Study Start: July 24, 2017 [Actual]
Primary Completion: March 31, 2018 [Actual]
Study Completion: February 12, 2019 [Actual]
Sponsor/Collaborators
Sponsor: Mahidol University
Responsible Party: Principal Investigator
Investigator: Punnee Pitisuttithum [ppitisuthitham]
Official Title: Prof.
Affiliation: Mahidol University
Collaborators: The Government Pharmaceutical Organization
World Health Organization
Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
U.S. FDA IND/IDE: No
Human Subjects Review: Board Status: Approved
Approval Number: MUTM 2017-020-01
Board Name: Ethics Comittee of the Faculty of Tropical Medicine
Board Affiliation: Faculty of Tropical Medicine, Mahidol University
Phone: (662) 3069100
-  Page 1 of 5  -

Email: pornpimon.ada@mahidol.ac.th
Address:
Faculty of Tropical Medicine, Mahidol University
420/6 Rajvithi road, Ratchathewi, Bangkok 10400
Thailand
Data Monitoring: Yes
FDA Regulated Intervention: No
Study Description
Brief Summary: The study is aim to evaluate the immunogenicity and safety with two groups of
participants who will received a seasonal trivalent split, inactivated influenza
vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza
vaccine
Detailed Description: This is a phase II/III, non-inferiority double-blinded, randomized, controlled trial
of immunogenicity and safety with two groups of participants who will received
a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B)
or an active comparator (licensed influenza vaccine).
A total of about 945 healthy Thai male and female adult volunteers 18 through
49 years of age; 630 participants will be randomized to receive the GPO Tri
Fluvac and 315 will receive an active comparator (a 2:1 ratio) (inclusion of ~7%
lost to follow-up).
Safety will be assessed for all participants through Day 90 after vaccination.
Immunogenicity will be assessed in serum samples obtained at baseline and
21 days after vaccination in a subset of at least 586 individuals randomized to
study vaccine and 293 active comparator vaccine recipients.
Conditions
Conditions: Influenza
Keywords: GPO Tri Fluvac Vaccine
Tri Fluvac vaccine
Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
non-inferiority double-blinded, randomized, controlled trial
Number of Arms: 2
Masking: Double (Participant, Investigator)
double blinded
Allocation: Randomized
Enrollment: 945 [Actual]
-  Page 2 of 5  -

Arms and Interventions
Arms
Assigned Interventions
Active Comparator: GPO Tri Fluvac vaccine
630 volunteers will receive a single dose of the
seasonal trivalent inactivated influenza vaccine
(consisting of A/Michigan/45/2015 (H1N1)pdm-09-
like virus, A/Hong Kong/4801/2014 (H3N2)-like virus,
and B/Brisbane/60/2008-like virus) produced by GPO
Thailand. To be administered via the intramuscular
route; the preferred injection site will be the deltoid of
the non-dominant arm.
Biological/Vaccine: GPO Tri Fluvac vaccine
The vaccine will be administered via the intramuscular
route; the preferred injection site will be the deltoid of
the non-dominant arm.
Active Comparator: Licensed Influenza vaccine
315 volunteers will receive acLicensed Influenza
vaccine (seasonal trivalent inactivated split
virion influenza vaccine recommended for
Southern Hemisphere in 2017 (consisting of A/
Michigan/45/2015 (H1N1)pdm-09-like virus, A/
Hong Kong/4801/2014 (H3N2)-like virus, and B/
Brisbane/60/2008-like virus) 0.5 mL administered
intramuscularly (IM) in the deltoid muscle of the non-
dominant arm.
Biological/Vaccine: Licensed influenza vaccine
The comparator licensed influenza vaccine will be
administered via the intramuscular route; the preferred
injection site will be the deltoid of the non-dominant
arm.
Outcome Measures
Primary Outcome Measure:
1.  Primary Immunogenicity Endpoint: Immune responses to the GPO Tri Fluvac and active comparator vaccine at 21
days post-injection.
null [Time Frame: 21 days post-injection]
2.  Primary Safety Endpoints: Number of subjects with all Adverse Events during the study period and % of subjects with
all Adverse Events during the study period
null [Time Frame: upto 90 days]
Eligibility
Minimum Age: 18 Years
Maximum Age: 49 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria: Inclusion Criteria:
• Age 18-49 years old on the day of screening, having Thai ID card or
equivalent
• Able to read and write in Thai and sign written informed consent form
• Able to attend all scheduled visits and to comply with all trial procedures.
• Healthy or medically stable, as established by medical history and physical
examination. For individuals with medical conditions, symptoms/signs,
if present must be stable, under control or unchanged for the past three
months. If medication is used to treat the condition, the medication dose
must have been stable for at least one month preceding vaccination.
• For female participants:
-  Page 3 of 5  -

• Not breast feeding, non-pregnant (based on negative urine pregnancy
test) and no plan to become pregnant up to Day 60.
• Women who are not surgically sterile (hysterectomy or tubal ligation)
or post-menopausal for more than one year must be willing to use
effective contraceptive method to prevent pregnancy until Day 60 after
vaccination. Effective methods include intrauterine device, hormonal
contraceptives (oral, injectable, patch, implant, ring) or double barrier
contraceptives (condom or diaphragm with spermicide). Women with
credible history of abstinence may be enrolled at the discretion of the
investigator
Exclusion Criteria:
• Participation in another clinical trial involving any therapy within the
previous three months or planned enrollment in such a trial during the
period of this study.
• Hypersensitivity after previous administration of any vaccine.
• Having a history of H1N1, H3N2 or Flu B infection within 3 months
preceding enrollment to the trial
• Vaccination against influenza in the past 6 months preceding enrollment to
the trial
• Receipt of any non-study vaccine within four weeks prior to enrollment or
refusal to postpone receipt of such vaccines until after the Day 21 visit.
• 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)
• History of Guillain-Barré Syndrome.
• Having acute infection with fever > 38 degree Celsius or noninfectious
diseases (within 72 hours) preceding enrollment in the trial
• Volunteers who have been taking immunoglobulin products or have had a
blood transfusion during past 3 months before the beginning of the trial or
planned receipt of such products prior to the Day 21 visit.
• 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
Contacts/Locations
Central Contact Person: Punnee Pitisuttithum, Prof.
Telephone: (662) 6435599
Email: punnee.pit@mahidol.ac.th
Central Contact Backup:
Study Officials: Punnee Pitisuttithum, Prof.
Study Principal Investigator
Mahidol University
Locations: Thailand
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Contact: Punnee Pitisuttithum (662)6435599   punnee.pit@mahidol.ac.th
Principal Investigator: Punnee Pitisuttithum
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
-  Page 4 of 5  -

Bangkok, Thailand, 10400
Contact: Punnee Pitisuttithum 662-6445599   punnee.pit@mahidol.ac.th
Contact: 662-3549178
Principal Investigator: Punnee Pitisuttithum
IPDSharing
Plan to Share IPD: Undecided
References
Citations:
Links:
Available IPD/Information:
U.S. National Library of Medicine  |  U.S. National Institutes of Health  |  U.S. Department of Health & Human Services
-  Page 5 of 5  -

Protocol: GPO Tri Fluvac Vaccine Phase II/III_ Version 3.1 dated 13 Mar 2017 
Page 1 of 79 
 
Protocol No.: GPO Tri Fluvac Vaccine Phase II/III 
 
TITLE: A Phase II/III Double Blinded, Randomized, Controlled, Non-inferiority trial to evaluate 
the  Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated split virion 
Influenza vaccine, in healthy THAI subjects aged 18 – 49 years.  
PARTICIPATING INSTITUTIONS 
INVESTIGATORS: 
Principal Investigator 
Punnee Pitisuttithum, MBBS, DTM&H, FRCPT 
Vaccine Trial Center and Department of Clinical Tropical Medicine,  
Faculty of Tropical Medicine, Mahidol University 
420/6 Ratchawithi road, Ratchathewi, Bangkok 10400, Thailand  
Tel: +662 643 5599 Fax: +662 643 5598 
 
Co-Investigators 
Jittima Dhitavat, MD 
Arom Pitisuthitham, MD 
Swangjai Pungpak, MD 
Kobporn Boonnak, PhD 
Vaccine Trial Centre and Department of Clinical Tropical Medicine,  
Faculty of Tropical Medicine, Mahidol University 
420/6 Ratchawithi road, Ratchathewi, Bangkok 10400, Thailand  
Tel: +662 354 9100 ext. 2060 Fax: +662 643 5598  
 
Nathamon Kosoltanapiwat, PhD 
Department of Microbiology and Immunology, 
Faculty of Tropical Medicine, Mahidol University 
420/6 Ratchawithi road, Ratchathewi, Bangkok 10400, Thailand  
 
Saranath Lawpoolsri Niyom, MD.PhD. 
Center of Excellence for Biomedical Research and Public Health Informatics 
Faculty of Tropical Medicine, Mahidol University 
420/6 Ratchawithi road, Ratchathewi, Bangkok 10400, Thailand  
Tel: +662 354 9181 - 86 Fax: +662 354 9187 
 

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