InfluenzaPhase 3NCT05645900
A Clinical Trial of an Quadrivalent Influenza Virus Subunit Vaccine in Chinese Children Aged 6 to 35 Months
A Phase 3 study testing Quadrivalent influenza virus subunit vaccine and Quadrivalent split influenza virus vaccine in people with Influenza, run by Ab&B Bio-tech Co., Ltd.JS at 1 site in China.
Trial summary
A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent influenza virus subunit vaccine and Quadrivalent split influenza virus vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,772 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 13 Oct 2023
- Phase
- Phase 3
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-35 months healthy infants;
- The legal guardian voluntarily consented to the subject's participation in the study, and the legal guardian/trustee signed the Informed Consent Form and complied with the requirements of the protocol.
Who cannot join
- Exclusion criteria for the first dose:
- Armpit temperature ≥37.3℃ on the day of enrollment;
- Persons infected with influenza virus confirmed by laboratory testing within the previous 6 months;
- Received any influenza vaccine (registered or experimental) within the previous 12 months or planned to receive any influenza vaccine during the study period;
- Allergic to any components of the vaccine, such as eggs, excipients, formaldehyde, etc;
- Previous history of severe allergy to any vaccine or drug (e.g., but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction);
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- 6-23 months: premature (delivered before the 37th week of gestation), low weight (birth weight <2500g) , or a history of dystocia, asphyxia rescue, and neurological damage;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- Acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination;
- Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;
- History of asthma, instability within the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids;
- Progressive neurological disease, history of seizures, epilepsy, encephalopathy, Guillain-Barre syndrome, or history or family history of mental illness;
- Suffering from serious cardiovascular disease (heart disease, pulmonary heart disease, pulmonary edema);
- Asplenia, functional asplenia, and asplenia or splenectomy resulting from any condition; Resection or partial resection of other important organs;
- History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease);
- A history of live attenuated vaccine vaccination within 14 days and a history of other vaccines within 7 days before vaccination;
- Immune-boosting or suppressant therapy within 3 months (continuous oral or intravenous infusion for more than 14 days);
- Received blood or blood-related products;
- Plan to relocate prior to the completion of the study or to be away for an extended period during the scheduled study visit;
- Being or planning to participate in other clinical trials in the near future;
- Any ineligibility to participate in the trial was determined by the investigator.
- Exclusion criteria for the second dose:
- Severe allergic reaction after the first dose of vaccine;
- Serious adverse reactions related to the first dose of vaccine;
- The investigator will decide whether to continue to participate in the study if new findings or new occurrence after the first dose inoculation do not meet the inclusion criteria of the first dose or the exclusion criteria of the first dose;
- Other reasons for exclusion, according to the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of a Quadrivalent Influenza Virus Subunit Vaccine in Subjects Aged 6-35 Months : A Randomized, Double-blind, Active-controlled Phase III Trial
A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months.
A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart.
Read more
Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered.
Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection.
Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.
- Conditions
- Influenza
- Being tested
- Quadrivalent influenza virus subunit vaccine, Quadrivalent split influenza virus 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 influenza virus subunit vaccineBiological
This vaccine（0.5ml） is produced by Ab\&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection
Quadrivalent influenza virus subunit vaccineBiological
This vaccine（0.25ml） is produced by Ab\&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection
Quadrivalent split influenza virus vaccineBiological
This vaccine（0.25ml） is produced by HUALAN BIO。Subjects will receive two doses of quadrivalent split influenza virus vaccine administered 28 days apart by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| experimental vaccine 1 | Experimental | Subjects received 2 doses of 0.5 mL of quadrivalent influenza virus subunit vaccine, 28 days apart Receives: Biological: Quadrivalent influenza virus subunit vaccine |
| experimental vaccine 2 | Experimental | Subjects received 2 doses of 0.25 mL of quadrivalent influenza virus subunit vaccine, 28 days apart Receives: Biological: Quadrivalent influenza virus subunit vaccine |
| control vaccine | Active comparator | Subjects received 2 doses of 0.25 mL of Quadrivalent split influenza virus vaccine, 28 days apart Receives: Biological: Quadrivalent split influenza virus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation
Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation
Measured: Within 30 minutes after each dose
Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation
Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation
Measured: Within 0-7 days after each dose
Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation
Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation
Measured: Within 8-28/30 days after each dose
Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination
Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination
Measured: Within 6 months from the first dose to the full course of vaccination
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization
Measured: At 28 days after full immunization
Secondary outcomes (2)
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization
Measured: At 3 months after full immunization
The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization
The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization
Measured: At 6 months after full immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start6 Feb 2023
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
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.
- 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
- 2,772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645900
- Sponsor's protocol ID
- 2017L04970/1-3
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2022
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Quadrivalent Influenza Virus Subunit Vaccine in Subjects Aged 6-35 Months : A Randomized, Double-blind, Active-controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT05645900
- Acronym / sponsor ID
- 2017L04970/1-3
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,772 participants (actual)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 12 Dec 2022 (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 random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months.
A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart.
Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered.
Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection.
Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental vaccine 1 | Experimental | Biological: Quadrivalent influenza virus subunit vaccineSubjects received 2 doses of 0.5 mL of quadrivalent influenza virus subunit vaccine, 28 days apart |
| experimental vaccine 2 | Experimental | Biological: Quadrivalent influenza virus subunit vaccineSubjects received 2 doses of 0.25 mL of quadrivalent influenza virus subunit vaccine, 28 days apart |
| control vaccine | Active comparator | Biological: Quadrivalent split influenza virus vaccineSubjects received 2 doses of 0.25 mL of Quadrivalent split influenza virus vaccine, 28 days apart |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-35 months healthy infants;
- The legal guardian voluntarily consented to the subject's participation in the study, and the legal guardian/trustee signed the Informed Consent Form and complied with the requirements of the protocol.
Key exclusion criteria (26 listed)
- Exclusion criteria for the first dose:
- Exclusion criteria for the second dose:
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 influenza virus subunit vaccineThis vaccine（0.5ml） is produced by Ab\&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection | Biological | experimental vaccine 1 |
| Quadrivalent influenza virus subunit vaccineThis vaccine（0.25ml） is produced by Ab\&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection | Biological | experimental vaccine 2 |
| Quadrivalent split influenza virus vaccineThis vaccine（0.25ml） is produced by HUALAN BIO。Subjects will receive two doses of quadrivalent split influenza virus vaccine administered 28 days apart by intramuscular injection | Biological | control vaccine |
Primary outcome
Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation
Time frame: Within 30 minutes after each dose
Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation
Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation
Time frame: Within 0-7 days after each dose
Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation
Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation
Time frame: Within 8-28/30 days after each dose
Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation
Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination
Time frame: Within 6 months from the first dose to the full course of vaccination
Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization
Time frame: At 28 days after full immunization
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization
2 secondary outcomes
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization
Time frame: At 3 months after full immunization
The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization
Time frame: At 6 months after full immunization
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 2 Jan 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent influenza virus subunit vaccine and Quadrivalent split influenza virus vaccine in people with Influenza, run by Ab&B Bio-tech Co., Ltd.JS 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 2 inclusion and 26 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 2 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 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 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?
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?
Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation (time frame: Within 30 minutes after each dose). The study lists 5 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 2 Jan 2026.