Influenza, HumanPhase 1NCT06622590
Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
A Phase 1 study testing QIV in people with Influenza, Human and Influenza a, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity 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 a, Influenza Type B
- What is being tested?
- QIV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2024to 31 Jul 2025
- Phase
- Phase 1
- 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.
- Temperature Requirement: Axillary body temperature is less than 37.3°C.
- Requirements for contraception: agree to take contraception actions in 6 months
- 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 3-8 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
Show all 21Show fewer
- 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 are acutely ill 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 6 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
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Blinded, and Positive Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above
This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary 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 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.
Read the detailed description
This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity in 180 subjects (aged 3 years and above). Then 40 adults (aged 18-59 years), 40 elders (aged 60 years and above), 40 adolescents (aged 9-17 years), and 60 children (aged 3-8 years) are eligible for enrollment after assessing through the medical history and physical examination according to the principle of age escalating from adults to children.
40 adults in the first stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 1:1, that is, 20 subjects in such group will be injected with the experimental or active-controlled vaccine. The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection. If the results meet the criterion, the study will continue to the second stage after putting the record to IRB.
40 elders and 40 adolescents in the second stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 1:1, respectively, that is 40 subjects in such group will be injected with the experimental or active-controlled vaccine. The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection. If the results meet the criterion, the study will continue to the third stage after putting the record to IRB.
60 children in the third stage of the study will be randomly assigned to the 2-dose vaccine, 1-dose vaccine, and control group in a ratio of 1:1:1, that is 20 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 0,28 program, and 20 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection. If the results meet the criterion, the study will continue to complete the second administration in the 2-dose vaccine cohort after putting the record to IRB.
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 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, blood biochemistry, blood routine, and urine routine tests or urine pregnancy tests (if applicable) will be performed on Day 0 before vaccination as well as Day 4 after administration for all subjects.
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.
- 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 (Adults aged 18-59 years, one-dose) | Experimental | QIV in adults aged 18-59 years on Day 0 Receives: Biological: QIV |
| Control (Adults aged 18-59 years, one-dose) | Active comparator | Control vaccine in adults aged 18-59 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 (Adolescents aged 9-17 years, one-dose) | Experimental | QIV in adolescents aged 9-17 years on Day 0 Receives: Biological: QIV |
| Control (Adolescents aged 9-17 years, one-dose) | Active comparator | Control vaccine in adolescents aged 9-17 years 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.
Safety index - incidence of adverse events/adverse reactions
Incidence of adverse events/adverse reactions after the first dose vaccination
Measured: 0-30 minutes 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: 0-30 minutes after the second dose 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 the first dose vaccination
Measured: Day 0 to 30 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 30 after the second dose vaccination
Secondary outcomes (5)
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.
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
Immunogenicity index - geometric mean fold increases (GMT) of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test.
Measured: Between baseline and 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 posted2 Oct 2024
- Study start13 Oct 2024
- Primary completion9 Jan 2025
- Study completion31 Jul 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Three stages will be conducted according to the age-escalating principle.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 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 Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622590
- Sponsor's protocol ID
- 20221201_1
- Status last verified
- Jan 2025
- First submitted
- 30 Sep 2024
- Last updated
- 28 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Blinded, and Positive Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above
- ClinicalTrials.gov ID
- NCT06622590
- Acronym / sponsor ID
- 20221201_1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 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
- 13 Oct 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 2 Oct 2024 (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 I clinical trial to evaluate the safety and preliminary immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary 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 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.
Detailed description
This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity in 180 subjects (aged 3 years and above). Then 40 adults (aged 18-59 years), 40 elders (aged 60 years and above), 40 adolescents (aged 9-17 years), and 60 children (aged 3-8 years) are eligible for enrollment after assessing through the medical history and physical examination according to the principle of age escalating from adults to children.
40 adults in the first stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 1:1, that is, 20 subjects in such group will be injected with the experimental or active-controlled vaccine. The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection. If the results meet the criterion, the study will continue to the second stage after putting the record to IRB.
40 elders and 40 adolescents in the second stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 1:1, respectively, that is 40 subjects in such group will be injected with the experimental or active-controlled vaccine. The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection. If the results meet the criterion, the study will continue to the third stage after putting the record to IRB.
60 children in the third stage of the study will be randomly assigned to the 2-dose vaccine, 1-dose vaccine, and control group in a ratio of 1:1:1, that is 20 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 0,28 program, and 20 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection. If the results meet the criterion, the study will continue to complete the second administration in the 2-dose vaccine cohort after putting the record to IRB.
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 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, blood biochemistry, blood routine, and urine routine tests or urine pregnancy tests (if applicable) will be performed on Day 0 before vaccination as well as Day 4 after administration for all subjects.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- Three stages will be conducted according to the age-escalating principle.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Adults aged 18-59 years, one-dose) | Experimental | Biological: QIVQIV in adults aged 18-59 years on Day 0 |
| Control (Adults aged 18-59 years, one-dose) | Active comparator | Biological: QIV controlControl vaccine in adults aged 18-59 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 (Adolescents aged 9-17 years, one-dose) | Experimental | Biological: QIVQIV in adolescents aged 9-17 years on Day 0 |
| Control (Adolescents aged 9-17 years, one-dose) | Active comparator | Biological: QIV controlControl vaccine in adolescents aged 9-17 years 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.
- Temperature Requirement: Axillary body temperature is less than 37.3°C.
- Requirements for contraception: agree to take contraception actions in 6 months
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 (Adolescents aged 9-17 years, one-dose), Intervention (Adults aged 18-59 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 (Adolescents aged 9-17 years, one-dose), Control (Adults aged 18-59 years, one-dose), Control (Children aged 3-8 years, one-dose), Control (Elders aged 60 years and above, one-dose) |
Primary outcome
Safety index - incidence of adverse events/adverse reactions
Time frame: 0-30 minutes 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: 0-30 minutes 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: 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: Day 0 to 30 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 30 after the second dose vaccination
Incidence of adverse events/adverse reactions after the second dose vaccination (applicable for the two-dose children cohort)
5 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
Immunogenicity index - geometric mean fold increases (GMT) of HI antibody against all types
Time frame: Between baseline and 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 28 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Influenza, Human
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Teng Huang principal investigator
Guangxi Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QIV in people with Influenza, Human and Influenza a, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site 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: under way, not looking for participants, as of the sponsor's last update on 28 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 1 site 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 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.
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?
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?
Safety index - incidence of adverse events/adverse reactions (time frame: 0-30 minutes after the first dose 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 28 Jan 2025.