InfluenzaPhase 4NCT07832201
A Phase IV Clinical Trial of Influenza Vaccine (Split Virion), Inactivatedin (Anflu®) Pregnant Women (AnFLU-PREG)
A Phase 4 study testing Anflu® and Vaxigrip® in people with Influenza, run by Sinovac Biotech Co., Ltd at 6 sites in China.
Trial summary
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in pregnant women. A total of 150 healthy pregnant women aged 18~45 years at 22 to 34 weeks (+6 days) of pregnancy will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Anflu® and Vaxigrip®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesChina
- Study dates
- Oct 2026to Apr 2027
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women aged 18 to 45 years (inclusive) with stable health status, at 22 to 34 weeks (+6 days) of gestation. Gestational age is determined based on early ultrasound examination, or based on the last menstrual period if early ultrasound is unavailable.
- Participants are able to understand and sign the informed consent form voluntarily;
- Participants are willing and able to adhere to visit schedules and maintain accessible contact throughout the study period;
- Participants should provide verifiable identification;
- Have a singleton pregnancy;
- Have normal non-invasive prenatal DNA test and systematic ultrasound results during the current pregnancy; normal amniocentesis results are required if the test has been performed.
Who cannot join
- Have a history of two or more preterm deliveries (delivery before 37 weeks of gestation), previous infants with low birth weight (birth weight <2500 g), or a history of neonatal asphyxia or neonatal neurological damage;
- Have a history of multiple unexplained spontaneous abortions;
- Have received any influenza vaccine or the influenza vaccine for the current influenza season within 6 months prior to enrollment, or plan to receive influenza vaccination during the study period.
- Have suffered from seasonal influenza within 6 months prior to enrollment.
- Have a history of Guillain-Barré syndrome within 6 weeks after previous influenza vaccination.
- Have allergic reactions or other severe adverse reactions to any influenza vaccine or its components.
Show all 18Show fewer
- Have severe autoimmune diseases or immunodeficiency diseases (including but not limited to active systemic lupus erythematosus, rheumatoid arthritis, asplenia, functional asplenia, and HIV infection) and are judged unsuitable for vaccination by the investigator.
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders or platelet abnormalities).
- Have severe chronic diseases (including but not limited to cardiovascular diseases, partial liver diseases, renal diseases or malignant tumors) that may interfere with the study as judged by the investigator.
- Have a current or previous history of severe neurological diseases (epilepsy, convulsions) or psychiatric disorders, or have a family history of psychiatric disorders.
- Received corticosteroids (adult prednisone ≥20 mg/day or equivalent) or other immunosuppressants for ≥14 days, or cytotoxic therapy within 6 months prior to vaccination, or plan to receive such therapy during the study period.
- Received immunoglobulins or other blood products within 3 months prior to vaccination, or plan to receive such products during the study period.
- Received any vaccine within 28 days prior to study vaccination, or plan to receive any vaccine within 28 days after study vaccination.
- Have enrolled in other clinical trials of investigational drugs or vaccines during the follow-up period, or plan to receive investigational drugs or vaccines during the study period.
- Have acute diseases or acute exacerbation of chronic diseases within 7 days before vaccination.
- Have fever on the scheduled vaccination day with an axillary temperature ≥37.3 °C before vaccination.
- Have clinically significant abnormal laboratory findings as judged by the investigator, or meet any of the following laboratory criteria: a) White blood cell count >15.0×10^9/L; b) Neutrophil percentage >85%; c) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (2×ULN); d) Total bilirubin >2 times the upper limit of normal (2×ULN).
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Hunan Provincial Maternal and Child Health Care Hospital
Changsha
Tang Yabing
Chengdu Women's and Children's Central Hospital
Chengdu
Lai Fan
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Qi Hongbo
Nanfang Hospital, Southern Medical University
Guangzhou
Huang Liping
Nanjing Drum Tower Hospita
Nanjing
Li Jie
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Feng Ling
About this study
Official title: A Phase IV, Randomized, Double-blind, Positive-controlled , Multicenter Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine (Split Virion) , Inactivated (Anflu®) in Pregnant Women
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in pregnant women.
A total of 150 healthy pregnant women aged 18~45 years at 22 to 34 weeks (+6 days) of pregnancy will be enrolled. All participants will be randomized to test group and control group in a ratio of 2:1 and receive one dose of vaccine (0.5 mL) of Sinovac Influenza Vaccine (Split Virion) , Inactivated (Anflu®) or Sanofi VAXIGRIP®, respectively.
Read the detailed description
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in Chinese pregnant women.
A total of 150 healthy pregnant women aged 18~45 years at 22 to 34 weeks (+6 days) of pregnancy will be enrolled.The trial is a randomized, double-blind, positive controlled study to evaluate the immunogenicity and safety of Influenza Vaccine (Split Virion) ,Inactivated (Anflu®) manufactured by Sinovac. The active control vaccine is VAXIGRIP® manufactured by Sanofi.
For immunogenicity assessment, blood samples will be collected from participants prior to vaccination, 28 days post-vaccination, and at the end of pregnancy (at delivery) to evaluate antibody levels in pregnant women following influenza vaccination. Additionally, the cord blood samples will be collected at delivery to assess transplacental antibody transfer to the fetus. Antibodies will be tested using the hemagglutination-inhibition (HI) assay.
For safety assessment, any immediate adverse events within 30 minutes after vaccine administration, solicited local and systemic adverse events within 7 days and unsolicited adverse events within 28 days will be collected. Serious adverse events will be collected from the time of informed consent signature until 3 months after delivery (or until 3 months after the event if pregnancy termination occurs). Pregnancy and neonatal outcomes will be collected by medical record review .
- Conditions
- Influenza
- Being tested
- Anflu®, Vaxigrip®
- Keywords
- pregnant women
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anflu®Biological
Participants will receive one dose of Sinovac Anflu® .
Vaxigrip®Biological
Participants will receive one dose of Sanofi Vaxigrip®.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | 100 participants will receive one dose of vaccine (0.5 mL) of Sinovac Influenza Vaccine (Split Virion) Inactivated (Anflu®) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose Receives: Biological: Anflu® |
| Control Group | Active comparator | 50 participants will receive one dose of vaccine (0.5 mL) of VAXIGRIP® manufactured by Sanofi. Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose Receives: Biological: Vaxigrip® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroconversion is defined as either a baseline HI titer <1:10 and a post-vaccination titer ≥1:40 or a baseline HI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HI antibody titer.
Measured: 28 days after vaccination
Incidence of adverse reactions within 28 days after vaccination
Incidence of adverse reactions within 28 days after vaccination. Adverse reactions include solicited and unsolicited adverse reactions. Solicited local (injection site) symptoms: pain, swelling, erythema, induration, pruritus; Solicited systemic (non-injection site) symptoms: fever (axillary temperature), fatigue, myalgia, headache, hypersensitivity reaction.
Measured: 28 days after vaccination
Secondary outcomes (12)
The seroprotection rates (SPRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroprotection is defined as an HI titer ≥1: 40.
Measured: 28 days after vaccination
The geometric mean titers (GMTs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Log-transformed post-vaccination HI antibody titer will be the dependent variable, with treatment group as fixed effect and log-transformed pre-vaccination HI antibody titer as covariate. Least-squares mean differences with two-sided 95% CIs will be estimated and back-transformed via exponentiation to derive adjusted GMT ratios (experimental vs control) and corresponding two-sided 95% CIs.
Measured: 28 days after vaccination
The geometric mean fold rises (GMFRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Geometric mean of antibody fold-rise with two-sided 95% CI will be calculated , along with the geometric mean ratio and its corresponding two-sided 95% CI.
Measured: 28 days after vaccination
The SCRs of HI antibodies at delivery, as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroconversion is defined as either a baseline HI titer <1:10 and a post-vaccination titer ≥1:40 or a baseline HI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HI antibody titer.
Measured: At the date of delivery , estimated to be 6-18 weeks after randomization.
The SPRs of HI antibodies at delivery ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroprotection is defined as an HI titer ≥1: 40.
Measured: At the date of delivery , estimated to be 6-18 weeks after randomization.
The GMTs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Log-transformed post-vaccination HI antibody titer will be the dependent variable, with treatment group as fixed effect and log-transformed pre-vaccination HI antibody titer as covariate. Least-squares mean differences with two-sided 95% CIs will be estimated and back-transformed via exponentiation to derive adjusted GMT ratios (experimental vs control) and corresponding two-sided 95% CIs.
Measured: At the date of delivery , estimated to be 6-18 weeks after randomization.
The GMFRs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Geometric mean of antibody fold-rise with two-sided 95% CI will be calculated , along with the geometric mean ratio and its corresponding two-sided 95% CI.
Measured: At the date of delivery , estimated to be 6-18 weeks after randomization.
The SPRs of HI antibodies in cord blood at delivery ,as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroprotection is defined as an HI titer ≥1: 40.
Measured: At the date of delivery, estimated to be 6-18 weeks after randomization
The GMTs of HI antibodies in cord blood at delivery, as measured by HAI assay for vaccine-matched influenza A and B
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Log-transformed post-vaccination HI antibody titer will be the dependent variable, with treatment group as fixed effect and log-transformed pre-vaccination HI antibody titer as covariate. Least-squares mean differences with two-sided 95% CIs will be estimated and back-transformed via exponentiation to derive adjusted GMT ratios (experimental vs control) and corresponding two-sided 95% CIs.
Measured: At the date of delivery, estimated to be 6-18 weeks after randomization
Incidence of serious adverse events from vaccination through 3 months after delivery.
Serious adverse events within 3 months after delivery.
Measured: From vaccination to 3 months after delivery.
Pregnancy outcomes
Pregnancy outcomes: term birth, preterm birth, elective termination of pregnancy, fetal death, and gestational complications, etc.
Measured: At the date of delivery, estimated to be 6-18 weeks after randomization
Neonatal birth outcomes
Birth outcomes: normal status, low birth weight, congenital malformations, neonatal NICU admission, and neonatal death, etc.
Measured: 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
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 Sinovac Biotech Co., LtdThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qi Hongbo, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832201
- Sponsor's protocol ID
- PRO-INF-4015
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Double-blind, Positive-controlled , Multicenter Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine (Split Virion) , Inactivated (Anflu®) in Pregnant Women
- ClinicalTrials.gov ID
- NCT07832201
- Acronym / sponsor ID
- PRO-INF-4015
- Conditions
- Influenza
- Keywords
- pregnant women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 21 Sep 2026 (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.
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in pregnant women.
A total of 150 healthy pregnant women aged 18~45 years at 22 to 34 weeks (+6 days) of pregnancy will be enrolled. All participants will be randomized to test group and control group in a ratio of 2:1 and receive one dose of vaccine (0.5 mL) of Sinovac Influenza Vaccine (Split Virion) , Inactivated (Anflu®) or Sanofi VAXIGRIP®, respectively.
Detailed description
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in Chinese pregnant women.
A total of 150 healthy pregnant women aged 18~45 years at 22 to 34 weeks (+6 days) of pregnancy will be enrolled.The trial is a randomized, double-blind, positive controlled study to evaluate the immunogenicity and safety of Influenza Vaccine (Split Virion) ,Inactivated (Anflu®) manufactured by Sinovac. The active control vaccine is VAXIGRIP® manufactured by Sanofi.
For immunogenicity assessment, blood samples will be collected from participants prior to vaccination, 28 days post-vaccination, and at the end of pregnancy (at delivery) to evaluate antibody levels in pregnant women following influenza vaccination. Additionally, the cord blood samples will be collected at delivery to assess transplacental antibody transfer to the fetus. Antibodies will be tested using the hemagglutination-inhibition (HI) assay.
For safety assessment, any immediate adverse events within 30 minutes after vaccine administration, solicited local and systemic adverse events within 7 days and unsolicited adverse events within 28 days will be collected. Serious adverse events will be collected from the time of informed consent signature until 3 months after delivery (or until 3 months after the event if pregnancy termination occurs). Pregnancy and neonatal outcomes will be collected by medical record review .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Biological: Anflu®100 participants will receive one dose of vaccine (0.5 mL) of Sinovac Influenza Vaccine (Split Virion) Inactivated (Anflu®) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Control Group | Active comparator | Biological: Vaxigrip®50 participants will receive one dose of vaccine (0.5 mL) of VAXIGRIP® manufactured by Sanofi. Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy pregnant women aged 18 to 45 years (inclusive) with stable health status, at 22 to 34 weeks (+6 days) of gestation. Gestational age is determined based on early ultrasound examination, or based on the last menstrual period if early ultrasound is unavailable.
- Participants are able to understand and sign the informed consent form voluntarily;
- Participants are willing and able to adhere to visit schedules and maintain accessible contact throughout the study period;
- Participants should provide verifiable identification;
- Have a singleton pregnancy;
Key exclusion criteria (18 listed)
- Have a history of two or more preterm deliveries (delivery before 37 weeks of gestation), previous infants with low birth weight (birth weight <2500 g), or a history of neonatal asphyxia or neonatal neurological damage;
- Have a history of multiple unexplained spontaneous abortions;
- Have received any influenza vaccine or the influenza vaccine for the current influenza season within 6 months prior to enrollment, or plan to receive influenza vaccination during the study period.
- Have suffered from seasonal influenza within 6 months prior to enrollment.
- Have a history of Guillain-Barré syndrome within 6 weeks after previous influenza 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 |
|---|---|---|
| Anflu®Participants will receive one dose of Sinovac Anflu® . | Biological | Test Group |
| Vaxigrip®Participants will receive one dose of Sanofi Vaxigrip®. | Biological | Control Group |
Primary outcome
The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: 28 days after vaccination
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroconversion is defined as either a baseline HI titer <1:10 and a post-vaccination titer ≥1:40 or a baseline HI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HI antibody titer.
Incidence of adverse reactions within 28 days after vaccination
Time frame: 28 days after vaccination
Incidence of adverse reactions within 28 days after vaccination. Adverse reactions include solicited and unsolicited adverse reactions. Solicited local (injection site) symptoms: pain, swelling, erythema, induration, pruritus; Solicited systemic (non-injection site) symptoms: fever (axillary temperature), fatigue, myalgia, headache, hypersensitivity reaction.
12 secondary outcomes
The seroprotection rates (SPRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: 28 days after vaccination
The geometric mean titers (GMTs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: 28 days after vaccination
The geometric mean fold rises (GMFRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: 28 days after vaccination
The SCRs of HI antibodies at delivery, as measured by HAI assay for vaccine-matched influenza A and B
Time frame: At the date of delivery , estimated to be 6-18 weeks after randomization.
The SPRs of HI antibodies at delivery ,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: At the date of delivery , estimated to be 6-18 weeks after randomization.
The GMTs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: At the date of delivery , estimated to be 6-18 weeks after randomization.
The GMFRs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: At the date of delivery , estimated to be 6-18 weeks after randomization.
The SPRs of HI antibodies in cord blood at delivery ,as measured by HAI assay for vaccine-matched influenza A and B
Time frame: At the date of delivery, estimated to be 6-18 weeks after randomization
The GMTs of HI antibodies in cord blood at delivery, as measured by HAI assay for vaccine-matched influenza A and B
Time frame: At the date of delivery, estimated to be 6-18 weeks after randomization
Incidence of serious adverse events from vaccination through 3 months after delivery.
Time frame: From vaccination to 3 months after delivery.
Pregnancy outcomes
Time frame: At the date of delivery, estimated to be 6-18 weeks after randomization
Neonatal birth outcomes
Time frame: 3 months after delivery
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 21 Sep 2026.
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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.
Qi Hongbo principal investigator
First Affiliated Hospital of Chongqing Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anflu® and Vaxigrip® in people with Influenza, run by Sinovac Biotech Co., Ltd at 6 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 18 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Qi Hongbo (13808376116, qihongbo@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B (time frame: 28 days after vaccination). 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 21 Sep 2026.