InfluenzaPhase 1/2NCT02894840
Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults
A Phase 1/2 study testing an inactivated influenza vaccine in people with Influenza, run by Mahidol University.
Trial summary
The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection. 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?
- an inactivated influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- Phase
- Phase 1/2
- 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
- Healthy
- Age 18-49 years old
- Having Thai ID card or equivalent
- 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)
- Able to read and write and sign written informed consent form or assent form.
Who cannot join
- Known history of egg allergy
- Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrolment to the trial
- Vaccination against influenza in the past 6 months preceding enrolment to the trial
- History of bronchial asthma, chronic lung diseases, chronic rhinitis
- History of immunodeficiency state
- History of immunosuppression < 6 months prior to immunization
Show all 13Show fewer
- 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 volunteers 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
About this study
Official title: A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Split Virion Influenza Vaccine in Healthy Thai Adults Aged Between 18 Years to 49 Years
The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.
Read the detailed description
This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be given in both Phase I and Phase II of the study.
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days.
Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.
- Conditions
- Influenza
- Being tested
- an inactivated influenza vaccine, Placebo
- 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.
an inactivated influenza vaccineBiological
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
PlaceboOther
The placebo 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 |
|---|---|---|
| an inactivated influenza vaccine | Active comparator | 20 volunteers in phase I study and 200 volunteers in phase II study will receive a single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. Receives: Biological: an inactivated influenza vaccine |
| Placebo | Placebo comparator | 20 volunteers in phase I study and 100 volunteers in phase II study will receive a single dose of placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine
Measured: 90 days
Secondary outcomes (3)
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
Seroconversion is defined as a 4-fold rise in HAI 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.
Measured: 90 days
Geometric Mean of Immune Response at Every Time of Assessment
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 (Days 0,21, 60 and 90)
Measured: 90 days
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
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 (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer > 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionNov 2016
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 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
- NCT02894840
- Sponsor's protocol ID
- GPO Tri Fluvac Vaccine
- Status last verified
- Mar 2020
- First submitted
- 24 Aug 2016
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Split Virion Influenza Vaccine in Healthy Thai Adults Aged Between 18 Years to 49 Years
- ClinicalTrials.gov ID
- NCT02894840
- Acronym / sponsor ID
- GPO Tri Fluvac Vaccine
- Conditions
- Influenza
- Keywords
- GPO Tri Fluvac Vaccine, Tri Fluvac Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- The Government Pharmaceutical Organization, World Health Organization
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Posted 19 Sep 2018
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 safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.
Detailed description
This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be given in both Phase I and Phase II of the study.
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days.
Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| an inactivated influenza vaccine | Active comparator | Biological: an inactivated influenza vaccine20 volunteers in phase I study and 200 volunteers in phase II study will receive a single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
| Placebo | Placebo comparator | Other: Placebo20 volunteers in phase I study and 100 volunteers in phase II study will receive a single dose of placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Age 18-49 years old
- Having Thai ID card or equivalent
- 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)
- Able to read and write and sign written informed consent form or assent form.
Key exclusion criteria (13 listed)
- Known history of egg allergy
- Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrolment to the trial
- Vaccination against influenza in the past 6 months preceding enrolment to the trial
- History of bronchial asthma, chronic lung diseases, chronic rhinitis
- History of immunodeficiency state
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 |
|---|---|---|
| an inactivated influenza vaccineThe vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. | Biological | an inactivated influenza vaccine |
| PlaceboThe placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. | Other | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: 90 days
All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine
3 secondary outcomes
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
Time frame: 90 days
Geometric Mean of Immune Response at Every Time of Assessment
Time frame: 90 days
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing an inactivated influenza vaccine in people with Influenza, run by Mahidol University.
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 5 inclusion and 13 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Sep 2018). 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 of Participants With Adverse Events (time frame: 90 days). 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 17 Mar 2020.