InfluenzaPhase 4NCT05144464
A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
A Phase 4 study testing Quadrivalent influenza vaccine in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2021to 30 Apr 2022
- 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 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 3-8 years old
- Healthy subjects judged from medical history and clinical examination
- Subjects themselves or their guardians able to understand and sign the informed consent
- Subjects themselves or their guardians can and will comply with the requirements of the protocol
- Subjects have received ≥2 doses of trivalent or quadrivalent infuenza vaccine before enrollment (Doses need not have been received during same or consecutive seasons); Subjects have not received infuenza vaccine before enrollment
- Subjects with temperature <=37.0°C on axillary setting
Who cannot join
- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- Subject who is allergic to any ingredient of the vaccine
- Subject with damaged or low immune function which has already been known
- Subject with acute febrile illness or infectious disease
- Major congenital defects or serious chronic illness, including perinatal brain damage
- Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
Show all 15Show fewer
- Subject who has serious allergic history
- Subject who developed guillain-Barre syndrome post influenza vaccination
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of influenza vaccine in last 6 month
- Any prior administration of blood products in last 3 months
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of any attenuated live vaccine in last 14 days
- Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
- Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent for subject's guardian
Trial locations and contacts
1 site in 1 country.
China1 site
Pizhou City Center for Disease Control and Prevention
Xuzhou, Jiangsu
About this study
Official title: A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.
Read the detailed description
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.
Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point
- Conditions
- Influenza
- Being tested
- Quadrivalent influenza vaccine
- Keywords
- Safety, Immunogenicity, Quadrivalent 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 influenza vaccineBiological
Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain. Receives: Biological: Quadrivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40%
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Measured: day 28 after dose 2
Number of participants with Adverse Reactions (ARs)
Frequency and severity of ARs for 28 days after each vaccination
Measured: 28 days after each vaccination
Secondary outcomes (4)
the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
Measured: day 28 after dose 2
Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5
Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain
Measured: day 28 after dose 2
Number of participants with Adverse Events (AEs)
Frequency and severity of AEs for 28 days after each vaccination
Measured: 28 days after each vaccination
Number of participants with Serious Adverse Events (SAE)
Frequency of SAEs for 6 months after the last vaccination
Measured: 6 months after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start19 Sep 2021
- Primary completion23 Nov 2021
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects received 2 doses of an inactivated quadrivalent influenza vaccine, 4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Jiangsu Jindike Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Fangyue Meng, Master, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144464
- Sponsor's protocol ID
- JSVCT122
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wen F, Liu S, Zhou L, Zhu Y, Wang W, Wei M, Xu X, Liu Y, Shuai Q, Yu J, Jing P, Li J, Zhu F. Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3-8 years with or without previous influenza vaccination histories. Hum Vaccin Immunother. 2025 Dec;21(1):2468074. doi: 10.1080/21645515.2025.2468074. Epub 2025 Feb 24.
PubMed 39993940
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
- ClinicalTrials.gov ID
- NCT05144464
- Acronym / sponsor ID
- JSVCT122
- Conditions
- Influenza
- Keywords
- Safety, Immunogenicity, Quadrivalent influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Jiangsu Jindike Biotechnology Co., Ltd.
- Study start
- 19 Sep 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 3 Dec 2021 (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.
Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.
Detailed description
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.
Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects received 2 doses of an inactivated quadrivalent influenza vaccine, 4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2.
| Arm | Type | Receives |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Biological: Quadrivalent influenza vaccineSubjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 3-8 years old
- Healthy subjects judged from medical history and clinical examination
- Subjects themselves or their guardians able to understand and sign the informed consent
- Subjects themselves or their guardians can and will comply with the requirements of the protocol
- Subjects have received ≥2 doses of trivalent or quadrivalent infuenza vaccine before enrollment (Doses need not have been received during same or consecutive seasons); Subjects have not received infuenza vaccine before enrollment
Key exclusion criteria (15 listed)
- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- Subject who is allergic to any ingredient of the vaccine
- Subject with damaged or low immune function which has already been known
- Subject with acute febrile illness or infectious disease
- Major congenital defects or serious chronic illness, including perinatal brain damage
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 vaccineSubjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection | Biological | Quadrivalent influenza vaccine |
Primary outcome
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40%
Time frame: day 28 after dose 2
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Number of participants with Adverse Reactions (ARs)
Time frame: 28 days after each vaccination
Frequency and severity of ARs for 28 days after each vaccination
4 secondary outcomes
the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%
Time frame: day 28 after dose 2
Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5
Time frame: day 28 after dose 2
Number of participants with Adverse Events (AEs)
Time frame: 28 days after each vaccination
Number of participants with Serious Adverse Events (SAE)
Time frame: 6 months after the last vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 39993940Wen F, Liu S, Zhou L, Zhu Y, Wang W, Wei M, Xu X, Liu Y, Shuai Q, Yu J, Jing P, Li J, Zhu F. Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3-8 years with or without previous influenza vaccination histories. Hum Vaccin Immunother. 2025 Dec;21(1):2468074. doi: 10.1080/21645515.2025.2468074. Epub 2025 Feb 24.
Related trials for Influenza
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.
Fangyue Meng, Master principal investigator
Jiangsu Province Centers 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 4 study testing Quadrivalent influenza vaccine in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention 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 15 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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 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?
Results are not available in the source record.
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?
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40% (time frame: day 28 after dose 2). 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?
On the ClinicalTrials.gov record for NCT05144464, which also lists 1 linked publication.
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 31 Mar 2022.