InfluenzaPhase 2/3NCT03390166
Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults
A Phase 2/3 study testing GPO Tri Fluvac vaccine and Licensed influenza vaccine in people with Influenza, run by Mahidol University at 2 sites in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GPO Tri Fluvac vaccine and Licensed influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 945 participants
- Where
- 2 sitesThailand
- Study dates
- 24 Jul 2017to 12 Feb 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
Bangkok, 10400
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
About this study
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
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
Read the 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
- Influenza
- Being tested
- GPO Tri Fluvac vaccine, Licensed influenza vaccine
- Keywords
- GPO Tri Fluvac Vaccine, Tri Fluvac vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPO Tri Fluvac vaccineBiological
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
Licensed influenza vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| GPO Tri Fluvac vaccine | Active comparator | 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. Receives: Biological: GPO Tri Fluvac vaccine |
| Licensed Influenza vaccine | Active comparator | 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. Receives: Biological: Licensed influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination
Seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria.
Pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 21 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 21.
Measured against each of the 3 antigens
Measured: pre-vaccination (Day 0), 21 days post-vaccination
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination
Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 21) for each of the three vaccine antigens.
Note that titers below the lowest limit of quantitation (i.e., below the starting dilution of assay reported as "< 10") will be set to half that limit (i.e., 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set to that limit.
Measured: pre-vaccination (Day 0), 21 days post-vaccination
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination.
Solicited local and systemic adverse events within 30 minutes of vaccination and over the 3-day period post vaccination.
Percentage of participants experiencing each reaction was calculated. Analysis based on Intention to Treat analysis
Measured: 30-minutes period,day 1,day 2 and day 3 post-vaccination period
Number of Participants With Unsolicited Adverse Events.
Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated.
Measured: within 90 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start24 Jul 2017
- Primary completion31 Mar 2018
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-inferiority double-blinded, randomized, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- The Government Pharmaceutical Organization, World Health Organization
- Responsible party
- Principal investigator, Punnee Pitisuttithum, Mahidol University
- Investigators
- Punnee Pitisuttithum, Prof., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390166
- Sponsor's protocol ID
- Tri Fluvac Vaccine phase 2/3
- Status last verified
- Apr 2020
- First submitted
- 6 Jul 2017
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03390166
- Acronym / sponsor ID
- Tri Fluvac Vaccine phase 2/3
- Conditions
- Influenza
- Keywords
- GPO Tri Fluvac Vaccine, Tri Fluvac vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 945 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- The Government Pharmaceutical Organization, World Health Organization
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- non-inferiority double-blinded, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| GPO Tri Fluvac vaccine | Active comparator | Biological: GPO Tri Fluvac vaccine630 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. |
| Licensed Influenza vaccine | Active comparator | Biological: Licensed influenza vaccine315 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPO Tri Fluvac vaccineThe vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. | Biological | GPO Tri Fluvac vaccine |
| Licensed influenza vaccineThe comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. | Biological | Licensed Influenza vaccine |
Primary outcome
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination
Time frame: pre-vaccination (Day 0), 21 days post-vaccination
Seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria. Pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 21 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 21. Measured against each of the 3 antigens
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination
Time frame: pre-vaccination (Day 0), 21 days post-vaccination
Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 21) for each of the three vaccine antigens. Note that titers below the lowest limit of quantitation (i.e., below the starting dilution of assay reported as "< 10") will be set to half that limit (i.e., 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set to that limit.
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination.
Time frame: 30-minutes period,day 1,day 2 and day 3 post-vaccination period
Solicited local and systemic adverse events within 30 minutes of vaccination and over the 3-day period post vaccination. Percentage of participants experiencing each reaction was calculated. Analysis based on Intention to Treat analysis
Number of Participants With Unsolicited Adverse Events.
Time frame: within 90 days post-vaccination
Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Punnee Pitisuttithum, Prof. principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GPO Tri Fluvac vaccine and Licensed influenza vaccine in people with Influenza, run by Mahidol University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination (time frame: pre-vaccination (Day 0), 21 days post-vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.