Influenza VaccineNCT07332689
Safety Study of Quadrivalent Subunit Influenza Vaccine in People Aged 3 Years and Older
An observational study of Influenza Vaccine, run by Ab&B Bio-tech Co., Ltd.JS at 8 sites in China.
Trial summary
This study evaluates the safety of the quadrivalent subunit influenza vaccine following its post-marketing widespread use in individuals aged 3 years and older, aiming to assess the occurrence of very rare adverse reactions (with an incidence rate of <0.01%). Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine
- What is being tested?
- quadrivalent subunit influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 42,881 participants
- Where
- 8 sitesChina
- Study dates
- 30 Oct 2023to 28 Apr 2025
- Phase
- Observational
- 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
Study population: Healthy individuals aged 3 years or above
Who may be able to join
- Healthy individuals aged 3 years or above.
- The participant (and/or their guardian/legal representative) has provided informed consent, voluntarily agreed to participate, signed the Informed Consent Form, and is able to comply with the requirements of this study protocol.
Who cannot join
- Individuals with a known allergy to any component of the vaccine, including eggs, excipients, formaldehyde, or Triton N-101.
- Individuals suffering from an acute illness, severe chronic disease, an acute exacerbation of a chronic disease, common cold, or fever.
- Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barré syndrome.
- Any other condition considered by the investigator as inappropriate for participation in this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Guangdong Provincial Institute of Biological Products and Materia Medica
Guangzhou, Guangdong, 510440
Shandong Center for Disease Control and Prevention
Jinan, Shandong, 250014
Gansu Provincial Center for Disease Control and Prevention
Lanzhou, Gansu, 730000
Jiangsu Provincial Academy of Preventive Medicine
Nanjing, Jiangsu, 210009
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai Municipality, 200336
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Ürümqi, Xinjiang Uygur Autonomous Region, 830002
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, 430079
Qinghai Provincial Center for Disease Control and Prevention
Xining, Qinghai, 810007
About this study
Official title: A Safety Study of Quadrivalent Subunit Influenza Vaccine in a Large-Scale Population Aged 3 Years and Older
This study evaluates the safety of the quadrivalent subunit influenza vaccine following its post-marketing widespread use in individuals aged 3 years and older, aiming to assess the occurrence of very rare adverse reactions (with an incidence rate of <0.01%).
Read the detailed description
This is a large-scale, multicenter, open-label, single-arm, non-controlled real-world safety observational study following influenza vaccination. It is designed to assess the occurrence of very rare adverse reactions (incidence <0.01%) following vaccination with a quadrivalent influenza subunit vaccine and to demonstrate its superior safety profile.
A total of 42,881 participants aged 3 years and above were enrolled. Each received a single 0.5 ml dose of the quadrivalent influenza subunit vaccine. Safety monitoring included immediate observation for 30 minutes post-vaccination and systematic surveillance over the subsequent 28 days. Data on adverse events (AEs) and serious adverse events (SAEs) were collected during two time intervals: from 30 minutes to 7 days (inclusive) and from 8 to 28 days (inclusive) after vaccination. Any newly identified adverse reactions during the study period were also recorded.
- Conditions
- Influenza Vaccine
- Being tested
- quadrivalent subunit influenza vaccine
- Keywords
- Safety, Quadrivalent Subunit Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadrivalent subunit influenza vaccineBiological
one dose of quadrivalent subunit influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| One dose Vaccine in aged 3 years and older | Not described Receives: Biological: quadrivalent subunit influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Occurrence of adverse events (AEs) within 30 minutes, 7 days, and 28 days after vaccination
Measured: 30 minutes, 7 days, and 28 days after vaccination
Adverse Drug Reactions（ADR）
Incidence of known adverse drug reactions (ADRs) within 30 minutes, 7 days, and 28 days after vaccination
Measured: 30 minutes, 7 days, and 28 days after vaccination
Serious Adverse Events (SAEs)
Occurrence of serious adverse events (SAEs) within 28 days after vaccination; Incidence of new adverse reactions following vaccination
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start30 Oct 2023
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccineStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42,881 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial Academy of Preventive Medicine, Hubei Provincial Center for Disease Control and Prevention, Shandong Province Centers for Disease Control and Prevention, Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Gansu Provincial Center for Disease Control and Prevention, Guangdong Provincial Institute of Biological Products And Materia Medica, Qinghai Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332689
- Sponsor's protocol ID
- CDRZ20234001-2
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Quadrivalent Subunit Influenza Vaccine in a Large-Scale Population Aged 3 Years and Older
- ClinicalTrials.gov ID
- NCT07332689
- Acronym / sponsor ID
- CDRZ20234001-2
- Conditions
- Influenza Vaccine
- Keywords
- Safety, Quadrivalent Subunit Influenza Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,881 participants (actual)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Jiangsu Provincial Academy of Preventive Medicine, Hubei Provincial Center for Disease Control and Prevention, Shandong Province Centers for Disease Control and Prevention, Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Gansu Provincial Center for Disease Control and Prevention, Guangdong Provincial Institute of Biological Products And Materia Medica, Qinghai Provincial Center for Disease Control and Prevention
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 12 Jan 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.
This study evaluates the safety of the quadrivalent subunit influenza vaccine following its post-marketing widespread use in individuals aged 3 years and older, aiming to assess the occurrence of very rare adverse reactions (with an incidence rate of <0.01%).
Detailed description
This is a large-scale, multicenter, open-label, single-arm, non-controlled real-world safety observational study following influenza vaccination. It is designed to assess the occurrence of very rare adverse reactions (incidence <0.01%) following vaccination with a quadrivalent influenza subunit vaccine and to demonstrate its superior safety profile.
A total of 42,881 participants aged 3 years and above were enrolled. Each received a single 0.5 ml dose of the quadrivalent influenza subunit vaccine. Safety monitoring included immediate observation for 30 minutes post-vaccination and systematic surveillance over the subsequent 28 days. Data on adverse events (AEs) and serious adverse events (SAEs) were collected during two time intervals: from 30 minutes to 7 days (inclusive) and from 8 to 28 days (inclusive) after vaccination. Any newly identified adverse reactions during the study period were also recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One dose Vaccine in aged 3 years and older | – | Biological: quadrivalent subunit influenza vaccine |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy individuals aged 3 years or above
Key inclusion criteria (2 listed)
- Healthy individuals aged 3 years or above.
- The participant (and/or their guardian/legal representative) has provided informed consent, voluntarily agreed to participate, signed the Informed Consent Form, and is able to comply with the requirements of this study protocol.
Key exclusion criteria (4 listed)
- Individuals with a known allergy to any component of the vaccine, including eggs, excipients, formaldehyde, or Triton N-101.
- Individuals suffering from an acute illness, severe chronic disease, an acute exacerbation of a chronic disease, common cold, or fever.
- Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barré syndrome.
- Any other condition considered by the investigator as inappropriate for participation in this study.
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 subunit influenza vaccineone dose of quadrivalent subunit influenza vaccine | Biological | One dose Vaccine in aged 3 years and older |
Primary outcome
Adverse Events (AEs)
Time frame: 30 minutes, 7 days, and 28 days after vaccination
Occurrence of adverse events (AEs) within 30 minutes, 7 days, and 28 days after vaccination
Adverse Drug Reactions（ADR）
Time frame: 30 minutes, 7 days, and 28 days after vaccination
Incidence of known adverse drug reactions (ADRs) within 30 minutes, 7 days, and 28 days after vaccination
Serious Adverse Events (SAEs)
Time frame: 28 days after vaccination
Occurrence of serious adverse events (SAEs) within 28 days after vaccination; Incidence of new adverse reactions following vaccination
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 12 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine, run by Ab&B Bio-tech Co., Ltd.JS at 8 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 2 inclusion and 4 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 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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?
Adverse Events (AEs) (time frame: 30 minutes, 7 days, and 28 days after vaccination). The study lists 3 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 12 Jan 2026.