InfluenzaPhase 3NCT03744104
A Clinical Trial of A Quadrivalent Influenza Vaccine
A Phase 3 study testing Quadrivalent influenza vaccine, Trivalent influenza vaccine A and Trivalent influenza vaccine B in people with Influenza, run by Shanghai Institute Of Biological Products at 2 sites in China.
Trial summary
The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent influenza vaccine, Trivalent influenza vaccine A and Trivalent influenza vaccine B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,688 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2018to 8 Oct 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Over the age of three years,healthy population
- Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
- To comply with the requirements of clinical trial program
- Temperature≤37.0℃ on day of enrollment
Who cannot join
- A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months
- Any prior administration of influenza vaccine in last six months
- Allergy to any component in the vaccine, especially for egg allergy
- Allergy history of any previous vaccination or drug
- Acute episodes of chronic illness or acute illness on the day of vaccination
- Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days
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- Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids
- Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
- Asthma, required urgent treatment in last two years
- The blood products were received prior to the acceptance of the vaccine
- Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
- History of epilepsy, convulsions, or a family history of psychosis
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
- Plan to move or leave the area for an extended period of time before the end of the study
- Under anti-tb treatment
- Any prior administration of other research medicine/vaccine in last one month
- Women are pregnant or in the near future planned pregnancy or pregnancy test positive
Trial locations and contacts
2 sites in 1 country.
China2 sites
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu
Xinyi County Center for Disease Control and Prevention
Xuzhou, Jiangsu
About this study
Official title: Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years
The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.
- Conditions
- Influenza
- Being tested
- Quadrivalent influenza vaccine, Trivalent influenza vaccine A, Trivalent influenza vaccine B
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent influenza vaccineBiological
0.5 mL, intramuscular, one dose
Trivalent influenza vaccine ABiological
0.5 mL, intramuscular, one dose
Trivalent influenza vaccine BBiological
0.5 mL, intramuscular, one dose
| Study group | Role | What they receive |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Quadrivalent influenza vaccine(containing 2 subtypes of B lineage) Receives: Biological: Quadrivalent influenza vaccine |
| Trivalent influenza vaccine A | Active comparator | Trivalent influenza vaccine (containing B/Victoria lineage) Receives: Biological: Trivalent influenza vaccine A |
| Trivalent influenza vaccine B | Active comparator | Trivalent influenza vaccine (containing B/Yamagata lineage) Receives: Biological: Trivalent influenza vaccine B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that presented seroconversion post injection
- Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more.
- Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Measured: 30 days after inoculation
Geometric mean of Hemagglutination-inhibition titre post first study injection
- Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection.
- Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.
Measured: 30 days after inoculation
Secondary outcomes (2)
Number of participants that presented seroprotection post injection
- Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40.
- Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Measured: 30 days after inoculation
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
- For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval
- For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
Measured: Continuous observation for 30 days after two inoculations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start11 Oct 2018
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hu Yuemei, PhD, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744104
- Sponsor's protocol ID
- JSVCT060
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2018
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years
- ClinicalTrials.gov ID
- NCT03744104
- Acronym / sponsor ID
- JSVCT060
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,688 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Biological: Quadrivalent influenza vaccineQuadrivalent influenza vaccine(containing 2 subtypes of B lineage) |
| Trivalent influenza vaccine A | Active comparator | Biological: Trivalent influenza vaccine ATrivalent influenza vaccine (containing B/Victoria lineage) |
| Trivalent influenza vaccine B | Active comparator | Biological: Trivalent influenza vaccine BTrivalent influenza vaccine (containing B/Yamagata lineage) |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Over the age of three years,healthy population
- Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
- To comply with the requirements of clinical trial program
- Temperature≤37.0℃ on day of enrollment
Key exclusion criteria (17 listed)
- A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months
- Any prior administration of influenza vaccine in last six months
- Allergy to any component in the vaccine, especially for egg allergy
- Allergy history of any previous vaccination or drug
- Acute episodes of chronic illness or acute illness on the day of vaccination
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 |
|---|---|---|
| Quadrivalent influenza vaccine0.5 mL, intramuscular, one dose | Biological | Quadrivalent influenza vaccine |
| Trivalent influenza vaccine A0.5 mL, intramuscular, one dose | Biological | Trivalent influenza vaccine A |
| Trivalent influenza vaccine B0.5 mL, intramuscular, one dose | Biological | Trivalent influenza vaccine B |
Primary outcome
Number of participants that presented seroconversion post injection
Time frame: 30 days after inoculation
* Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more. * Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Geometric mean of Hemagglutination-inhibition titre post first study injection
Time frame: 30 days after inoculation
* Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection. * Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.
2 secondary outcomes
Number of participants that presented seroprotection post injection
Time frame: 30 days after inoculation
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
Time frame: Continuous observation for 30 days after two inoculations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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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.
Hu Yuemei, PhD principal investigator
Jiangsu Province Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent influenza vaccine, Trivalent influenza vaccine A and Trivalent influenza vaccine B in people with Influenza, run by Shanghai Institute Of Biological Products at 2 sites in China.
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 4 inclusion and 17 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 2 Jan 2024. 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 China. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 that presented seroconversion post injection (time frame: 30 days after inoculation). The study lists 2 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 2 Jan 2024.