Influenza, HumanPhase 3NCT06800950
Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
A Phase 3 study testing QIV in people with Influenza, Human and Influenza, Human Prevention, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 3 sites in China.
Trial summary
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Influenza, Human Prevention, Influenza a
- What is being tested?
- QIV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,400 participants
- Where
- 3 sitesChina
- Study dates
- 8 Feb 2025to 15 Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age Requirement: volunteers aged 3 years and above at the time of enrollment.
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Volutters, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
- Requirements for contraception: agree to take contraception actions in 6 months.
- Temperature Requirement: Axillary body temperature is less than 37.3°C.
- Previous Vaccination Requirements: (a) Received at least 1 dose of influenza vaccine within 1 year before screening in children aged 3-8 years; (b) Never received any influenza vaccine 1 year before screening in children aged over 3 years.
Who cannot join
- Subjects meeting any of the following exclusion criteria will be not eligible for enrollment.
- Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).
- Subjects with influenza illness (clinically, serologically, or microbiologically confirmed) within 6 months before screening and enrollment.
- Have received an influenza vaccine within 1 year before enrollment or scheduled to receive another influenza vaccine during the study period.
- Allergic to any component contained in the investigational vaccine, or previous history of severe allergic to any vaccine or drug, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria, etc.
- History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment, or subjects have scheduled to receive another vaccine within 1 month after receipt of the investigational vaccine
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- Subjects with convulsion, epilepsy, encephalopathy (such as moderate to severe hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumor, cerebral infarction, stroke, intracranial infection, etc.), psychiatric history or family history
- Have been diagnosed with a serious medical condition or congenital malformation that may interfere with the conduct or completion of the study (including but not limited to suffering from respiratory diseases such as asthma or during episodes of chronic bronchitis, Down syndrome, thalassemia, heart disease, severe cardiac arrhythmias, kidney disease, diabetes (diabetics with poor glycemic control or severe complications), autoimmune diseases, genetic allergies, Guillain-Barre syndrome, Crohn disease, malignancies, severe infectious/allergic skin diseases, etc.)
- Adults aged 18 years or older with medically uncontrolled abnormal blood pressure (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg or systolic blood pressure ≤ 90mmHg and/or diastolic blood pressure ≤ 60 mmHg)
- Subjects with acute illness or in the acute phase of a chronic illness within 3 days before vaccination
- Subjects with fever (axillary temperature ≥37.3 ° C) within 3 days before vaccination or use of antipyretic, analgesic, or antiallergic medications
- Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders
- Have received a blood transfusion or use of blood products within 3 months before enrollment, or planned to do so within 1 month after full immunization
- History of surgical removal of the spleen or other vital organs for any reason
- Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study
- Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure
- Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, etc
- Being lactating, pregnant (including a positive urine pregnancy test), or planning to become pregnant within 6 months of vaccination
- Subjects plan to move out of the local area before the end of the study or leave the local area for an extended period during the scheduled study visit
- Subjects with abnormal vital signs with clinical significance
- Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Xing'an Center for Disease Control and Prevention
Guilin, Guangxi
Bin He, 0773-6226818 ext. +86, 13507837693@163.com
Yangshuo Center for Disease Control and Prevention
Guilin, Guangxi
Chunyuan Yang, 0773-8815366 ext. +86, jkyangchunyuan@163.com
Binyang Center for Disease Control and Prevention
Nanning, Guangxi
Xiaoqin Gan, 0771-8250001 ext. +86, byxgxq@163.com
About this study
Official title: A Randomized, Blinded, Positive-controlled Phase III Clinical Trial of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.
Read the detailed description
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety in 4400 subjects (aged 3 years and above). Then 1760 children (aged 3-8 years), 1320 adults/adolescents (aged 9-59 years), and 1320 elders (aged 60 years and above) are eligible for enrollment after assessing the medical history and physical examination.
1760 children's strata contains 1320 children with no history of influenza vaccine and 440 children with a history of influenza vaccine. Those 1320 children to the 2-dose vaccine, 1-dose vaccine, and control group in a ratio of 1:1:1, that is 440 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 0,28 program, and 440 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The rest of the 440 children with a history of influenza vaccine will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 220 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 adults/adolescents will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 elders will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
The duration of intervention is no more than 1 month. With the 6-month safety monitoring after administration, the duration of the study is no more than 7 months.
For immunogenicity assessment, antibodies against all vaccine-related types of Influenza virus will be assessed in all subjects before vaccination and 30 days after full vaccination.
For safety assessment, the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diary/contact cards and investigators' phone calls. Besides, the observation and evaluation of serious adverse events up to 6 months after vaccination will be conducted by active reports by subjects' legal guardians, or investigators' phone calls as well as face-to-face visits. Meanwhile, subjects will be observed at the site for at least 30 minutes after each dose.
For laboratory examination, urine routine tests or urine pregnancy tests (if applicable) will be performed on Day 0 before vaccination.
- Conditions
- Influenza, Human, Influenza, Human Prevention, Influenza a, Influenza B, Influenza Viral Infections
- Being tested
- QIV, QIV Control
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QIVBiological
Quadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose
QIV ControlBiological
Quadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Aged 9-59 years, one-dose) | Experimental | QIV in adults and adolescents aged 9-59 years on Day 0 Receives: Biological: QIV |
| Control (Aged 9-59 years, one-dose) | Active comparator | Control Vaccine in adults and adolescents aged 9-59 years on Day 0 Receives: Biological: QIV Control |
| Intervention (Elders aged 60 years and above, one-dose) | Experimental | QIV in elders aged 60 years and above on Day 0 Receives: Biological: QIV |
| Control (Elders aged 60 years and above, one-dose) | Active comparator | Control vaccine in elders aged 60 years and above on Day 0 Receives: Biological: QIV Control |
| Intervention (Children aged 3-8 years, two-dose) | Experimental | QIV in children aged 3-8 years on Day 0 and Day 28 Receives: Biological: QIV |
| Intervention (Children aged 3-8 years, one-dose) | Experimental | QIV in children aged 3-8 years on Day 0 Receives: Biological: QIV |
| Control (Children aged 3-8 years, one-dose) | Active comparator | Control vaccine n children aged 3-8 years on Day 0 Receives: Biological: QIV Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index - seroconversion rates of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test. Seroconversion will be defined as a change from seronegative (Antibody titers<1:40) to seropositive (Antibody titers≥1:40), or a ≥4-fold increase from baseline.
Measured: Between baseline and Day 30 after full vaccination
Immunogenicity index - Seropositive rates of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test. Seropositive is defined as antibody titers≥1:40
Measured: Day 30 after full vaccination
Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test.
Measured: Day 30 after full vaccination
Safety index - incidence of adverse events/adverse reactions
Incidence of adverse events/adverse reactions after the first dose vaccination
Measured: Day 0 to 7 after the first dose vaccination
Safety index - incidence of adverse events/adverse reactions
Incidence of adverse events/adverse reactions after the second dose vaccination (applicable for the two-dose children cohort)
Measured: Day 0 to 7 after the second dose vaccination
Safety index - incidence of adverse events/adverse reactions
Incidence of adverse events/adverse reactions after full vaccination
Measured: From Day 0 to Day 30 after full vaccination
Secondary outcomes (4)
Safety index - incidence of serious adverse events/adverse reactions
Incidence of serious adverse events/adverse reactions after vaccination
Measured: From the beginning of the vaccination up to 6 months after the last vaccination completed
Immunogenicity index - seroconversion rates of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test. Seroconversion will be defined as a change from seronegative (Antibody titers<1:40) to seropositive (Antibody titers≥1:40), or a ≥4-fold increase from baseline. (Applicable for susceptible cohort)
Measured: Between baseline and Day 30 after full vaccination
Immunogenicity index - Seropositive rates of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test. Seropositive is defined as antibody titers≥1:40 (Applicable for susceptible cohort)
Measured: Day 30 after full vaccination
Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test. (Applicable for susceptible cohort)
Measured: Day 30 after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start8 Feb 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- Responsible party
- Sponsor
- Investigators
- Teng Huang, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800950
- Sponsor's protocol ID
- 20221201_3
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Positive-controlled Phase III Clinical Trial of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above
- ClinicalTrials.gov ID
- NCT06800950
- Acronym / sponsor ID
- 20221201_3
- Conditions
- Influenza, Human, Influenza, Human Prevention, Influenza a, Influenza B, Influenza Viral Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- Study start
- 8 Feb 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 30 Jan 2025 (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.
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.
Detailed description
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety in 4400 subjects (aged 3 years and above). Then 1760 children (aged 3-8 years), 1320 adults/adolescents (aged 9-59 years), and 1320 elders (aged 60 years and above) are eligible for enrollment after assessing the medical history and physical examination.
1760 children's strata contains 1320 children with no history of influenza vaccine and 440 children with a history of influenza vaccine. Those 1320 children to the 2-dose vaccine, 1-dose vaccine, and control group in a ratio of 1:1:1, that is 440 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 0,28 program, and 440 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The rest of the 440 children with a history of influenza vaccine will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 220 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 adults/adolescents will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 elders will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
The duration of intervention is no more than 1 month. With the 6-month safety monitoring after administration, the duration of the study is no more than 7 months.
For immunogenicity assessment, antibodies against all vaccine-related types of Influenza virus will be assessed in all subjects before vaccination and 30 days after full vaccination.
For safety assessment, the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diary/contact cards and investigators' phone calls. Besides, the observation and evaluation of serious adverse events up to 6 months after vaccination will be conducted by active reports by subjects' legal guardians, or investigators' phone calls as well as face-to-face visits. Meanwhile, subjects will be observed at the site for at least 30 minutes after each dose.
For laboratory examination, urine routine tests or urine pregnancy tests (if applicable) will be performed on Day 0 before vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Intervention (Aged 9-59 years, one-dose) | Experimental | Biological: QIVQIV in adults and adolescents aged 9-59 years on Day 0 |
| Control (Aged 9-59 years, one-dose) | Active comparator | Biological: QIV ControlControl Vaccine in adults and adolescents aged 9-59 years on Day 0 |
| Intervention (Elders aged 60 years and above, one-dose) | Experimental | Biological: QIVQIV in elders aged 60 years and above on Day 0 |
| Control (Elders aged 60 years and above, one-dose) | Active comparator | Biological: QIV ControlControl vaccine in elders aged 60 years and above on Day 0 |
| Intervention (Children aged 3-8 years, two-dose) | Experimental | Biological: QIVQIV in children aged 3-8 years on Day 0 and Day 28 |
| Intervention (Children aged 3-8 years, one-dose) | Experimental | Biological: QIVQIV in children aged 3-8 years on Day 0 |
| Control (Children aged 3-8 years, one-dose) | Active comparator | Biological: QIV ControlControl vaccine n children aged 3-8 years on Day 0 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age Requirement: volunteers aged 3 years and above at the time of enrollment.
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Volutters, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
- Requirements for contraception: agree to take contraception actions in 6 months.
- Temperature Requirement: Axillary body temperature is less than 37.3°C.
Key exclusion criteria (21 listed)
- Subjects meeting any of the following exclusion criteria will be not eligible for enrollment.
- Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).
- Subjects with influenza illness (clinically, serologically, or microbiologically confirmed) within 6 months before screening and enrollment.
- Have received an influenza vaccine within 1 year before enrollment or scheduled to receive another influenza vaccine during the study period.
- Allergic to any component contained in the investigational vaccine, or previous history of severe allergic to any vaccine or drug, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria, etc.
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 |
|---|---|---|
| QIVQuadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose | Biological | Intervention (Aged 9-59 years, one-dose), Intervention (Children aged 3-8 years, one-dose), Intervention (Children aged 3-8 years, two-dose), Intervention (Elders aged 60 years and above, one-dose) |
| QIV ControlQuadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose | Biological | Control (Aged 9-59 years, one-dose), Control (Children aged 3-8 years, one-dose), Control (Elders aged 60 years and above, one-dose) |
Primary outcome
Immunogenicity index - seroconversion rates of HI antibody against all types
Time frame: Between baseline and Day 30 after full vaccination
Antibody assay will be performed using the hemagglutination inhibition test. Seroconversion will be defined as a change from seronegative (Antibody titers<1:40) to seropositive (Antibody titers≥1:40), or a ≥4-fold increase from baseline.
Immunogenicity index - Seropositive rates of HI antibody against all types
Time frame: Day 30 after full vaccination
Antibody assay will be performed using the hemagglutination inhibition test. Seropositive is defined as antibody titers≥1:40
Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types
Time frame: Day 30 after full vaccination
Antibody assay will be performed using the hemagglutination inhibition test.
Safety index - incidence of adverse events/adverse reactions
Time frame: Day 0 to 7 after the first dose vaccination
Incidence of adverse events/adverse reactions after the first dose vaccination
Safety index - incidence of adverse events/adverse reactions
Time frame: Day 0 to 7 after the second dose vaccination
Incidence of adverse events/adverse reactions after the second dose vaccination (applicable for the two-dose children cohort)
Safety index - incidence of adverse events/adverse reactions
Time frame: From Day 0 to Day 30 after full vaccination
Incidence of adverse events/adverse reactions after full vaccination
4 secondary outcomes
Safety index - incidence of serious adverse events/adverse reactions
Time frame: From the beginning of the vaccination up to 6 months after the last vaccination completed
Immunogenicity index - seroconversion rates of HI antibody against all types
Time frame: Between baseline and Day 30 after full vaccination
Immunogenicity index - Seropositive rates of HI antibody against all types
Time frame: Day 30 after full vaccination
Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types
Time frame: Day 30 after full vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- 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.
Teng Huang principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
3 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 QIV in people with Influenza, Human and Influenza, Human Prevention, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 3 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 6 inclusion and 21 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: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoyang Liao (0871-68334483 ext. +86, liaogy@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity index - seroconversion rates of HI antibody against all types (time frame: Between baseline and Day 30 after full vaccination). The study lists 6 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 30 Jan 2025.