Influenza VaccinePhase 4NCT07710586
Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China
A Phase 4 study testing quadrivalent subunit influenza vaccine in people with Influenza Vaccine, run by Ab&B Bio-tech Co., Ltd.JS at 2 sites in China.
Trial summary
This study evaluates the safety of the quadrivalent subunit influenza vaccine in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence <0.01%), investigate the incidence of cerebral infarction following vaccination… 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, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,105 participants
- Where
- 2 sitesChina
- Study dates
- 15 Nov 2024to 29 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
2 sites in 1 country.
China2 sites
Dongtai Center for Disease Control and Prevention
Dongtai, Jiangsu, 224200
Lianshui County Center for Disease Control and Prevention
Lianshui, Jiangsu, 223400
About this study
Official title: Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine Following Post-Marketing in China: An Open-Label, Single-Arm Clinical Trial
This study evaluates the safety of the quadrivalent subunit influenza vaccine in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence <0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.
Read the detailed description
This is an open-label, single-arm, non-controlled, real-world safety study of the quadrivalent subunit influenza vaccine, designed to systematically track and evaluate the overall safety profile following vaccine administration.
The core objectives of this study are as follows:
- To assess the occurrence of rare adverse reactions with an incidence rate of less than 0.01% after vaccination;
- To investigate the incidence of cerebral infarction events following receipt of the study vaccine;
- To evaluate the incidence of systemic adverse events after vaccination among participants aged 9 to 17 years.
A total of 3,105 eligible participants aged 3 years and older who voluntarily receive the vaccine will be enrolled. All enrolled participants will be administered a single 0.5 mL intramuscular dose of the quadrivalent influenza subunit vaccine.
The safety monitoring protocol is arranged as follows:
- 30-minute immediate observation: On-site monitoring will be conducted at the vaccination clinic immediately after injection to detect immediate adverse reactions.
- 28-day systematic safety follow-up: Participants will perform daily self-monitoring of adverse events within 28 days after vaccination. Investigators will conduct two on-site centralized follow-up visits on Day 7 and Day 28 post-vaccination respectively, to verify and collect adverse event data.
- 6-month serious adverse event monitoring: The occurrence of serious adverse events will be monitored via spontaneous reporting by participants within 6 months after vaccination.
- 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 |
|---|---|---|
| The quadrivalent influenza subunit vaccine Group | Experimental | receive a single 0.5 mL intramuscular dose of the quadrivalent influenza subunit vaccine 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 6 months after vaccination; Incidence of new adverse reactions following vaccination； Incidence of cerebral infarction following vaccination； Incidence of systemic adverse reactions following vaccination in individuals aged 9 to 17 years
Measured: 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Nov 2024
- Primary completion29 May 2025
- Study completion29 May 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710586
- Sponsor's protocol ID
- CTR20244333
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine Following Post-Marketing in China: An Open-Label, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07710586
- Acronym / sponsor ID
- CTR20244333
- Conditions
- Influenza Vaccine
- Keywords
- safety, Quadrivalent Subunit Influenza Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,105 participants (actual)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 17 Jul 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 in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence <0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.
Detailed description
This is an open-label, single-arm, non-controlled, real-world safety study of the quadrivalent subunit influenza vaccine, designed to systematically track and evaluate the overall safety profile following vaccine administration.
The core objectives of this study are as follows:
- To assess the occurrence of rare adverse reactions with an incidence rate of less than 0.01% after vaccination;
- To investigate the incidence of cerebral infarction events following receipt of the study vaccine;
- To evaluate the incidence of systemic adverse events after vaccination among participants aged 9 to 17 years.
A total of 3,105 eligible participants aged 3 years and older who voluntarily receive the vaccine will be enrolled. All enrolled participants will be administered a single 0.5 mL intramuscular dose of the quadrivalent influenza subunit vaccine.
The safety monitoring protocol is arranged as follows:
- 30-minute immediate observation: On-site monitoring will be conducted at the vaccination clinic immediately after injection to detect immediate adverse reactions.
- 28-day systematic safety follow-up: Participants will perform daily self-monitoring of adverse events within 28 days after vaccination. Investigators will conduct two on-site centralized follow-up visits on Day 7 and Day 28 post-vaccination respectively, to verify and collect adverse event data.
- 6-month serious adverse event monitoring: The occurrence of serious adverse events will be monitored via spontaneous reporting by participants within 6 months after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The quadrivalent influenza subunit vaccine Group | Experimental | Biological: quadrivalent subunit influenza vaccinereceive a single 0.5 mL intramuscular dose of the quadrivalent influenza subunit vaccine |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 | The quadrivalent influenza subunit vaccine Group |
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: 6 months after vaccination
Occurrence of serious adverse events (SAEs) within 6 months after vaccination; Incidence of new adverse reactions following vaccination； Incidence of cerebral infarction following vaccination； Incidence of systemic adverse reactions following vaccination in individuals aged 9 to 17 years
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 20 Jul 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.
2 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 quadrivalent subunit influenza vaccine in people with Influenza Vaccine, run by Ab&B Bio-tech Co., Ltd.JS at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
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 20 Jul 2026.