GCPNCT06095947
Exploration on the Quadrivalent Influenza Vaccine Immunization Schedule for Children Aged 3-8 Years
An observational study of GCP, run by Hualan Biological Bacterin Co. Ltd. at 1 site in China.
Trial summary
The goal of this [To evaluate the immunogenicity and safety of 1 - and 2-dose schedules of quadrivalent influenza vaccine (split virion) in healthy people with and without immunization history.] is to [aged 3-8 years] in [Healthy people]. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- GCP
- What is being tested?
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
- Type of treatment
- Vaccines
- How many people
- 652 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to 28 Feb 2023
- 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 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy people aged 3-8 years old
Who may be able to join
- 3-8 years old;
- The legal guardian / authorized agent gives the informed consent and voluntarily signs the informed consent to comply with the requirements of the clinical trial protocol;
- Medical history, physical examination and clinical diagnosis, who to the immunization of this product.
- children who have received two or more doses of influenza vaccine (4 weeks apart) before the season of this influenza epidemic (2 doses of influenza vaccine do not need to be vaccinated in the same epidemic season or consecutive epidemic season, but can be interpreted as children who have received two or more cumulative shots).
- History of l No immunization: children who had not been vaccinated or had previously received <2 doses of influenza vaccine before the influenza season.
Who cannot join
- 1.1.1The exclusion criteria for the first needle To l allergic to any component of the quadrialent influenza vaccine (history of any previous vaccine allergy), especially those allergic to eggs; The l axillary body temperature was 37.5℃ before inoculation;
- Any influenza vaccine (registered or research) within 6 months prior to enrollment; or planned for use during the study period;
- Use of immunoglobulin and / or any blood products within 3 months prior to enrollment; or planned for use during the study (before blood sampling);
- Patients with a history of Guillain-Barre syndrome; l Acute disease, severe chronic disease, acute onset of chronic disease, cold;
- Uncontrolled epilepsy;
- Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases;
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- those receiving immune booster or inhibitor treatment within 3 months (continuous oral or drip for more than 14 days);
- History of abnormal coagulation function (such as lack of coagulation factors, coagulation disease);
- Primary and secondary impaired immunity (history of thyroid, pancreas, liver and spleen resection);
- A history of severe allergic reactions to vaccination;
- live attenuated vaccine within 14 days before vaccination and other vaccines within 7 days before vaccination;
- Is in or recently planning to participate in other clinical trials;
- Other conditions judged by the investigator as not suitable for participation in this clinical trial.
- 1.1.2 Exclusion criteria for the second needle
- Patients with severe allergic reactions after the previous dose of vaccination;
- Serious adverse reactions with a causal relationship with the previous dose of vaccination; l For newly detected or those who do not meet the inclusion criteria of the first injection or meet the exclusion criteria of the first injection, the investigator will determine whether to continue to participate in the study;
- Other reasons for exclusion as considered by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Shandong Provincial Center for Disease Control and Prevention, China
The goal of this [To evaluate the immunogenicity and safety of 1 - and 2-dose schedules of quadrivalent influenza vaccine (split virion) in healthy people with and without immunization history.] is to [aged 3-8 years] in [Healthy people]. The main question[s] it aims to answer are: • [To evaluate the immunogenicity of a two-dose schedule of quadrivalent influenza vaccine (quadrivalent influenza vaccine) in healthy population aged 3-8 years with or without vaccination history.]
•[ To evaluate whether antibody levels are different 30 days after one dose of quadrivalent influenza vaccine versus two doses of quadrivalent influenza vaccine in healthy people aged 3-8 years with or without vaccination history.]
Read the detailed description
An open clinical trial design was used. A total of 652 healthy children aged 3-8 years, 326 with vaccination history and 326 without vaccination history, were selected to receive two doses of normal commercially available quadrivalent influenza vaccine according to a 0 -, 30-day schedule.
Immunogenicity: blood samples were collected for HI antibody detection before the first dose of influenza vaccine (before immunization), 30 days after the first dose of influenza vaccine (before the second dose of influenza vaccine) and 30 days after the second dose of influenza vaccine.
Adverse events (AE) were observed 30 minutes, 0-7 days and 8-30 days after each dose of vaccination by active follow-up combined with guardian reports. Occurrence of SAEs between 31 and 180 days after the second dose of vaccine.
Criteria for evaluation of immunogenicity According to the European Union seasonal influenza evaluation criteria, if the HI antibody seroconversion rate of each subtype of influenza virus was ≥40%, the HI antibody positive rate was ≥70%, and the GMI of each subtype of influenza virus was ≥2.5 times 30 days after any dose of vaccination, the vaccination schedule was considered to have acceptable immunogenicity.
Safety outcome MEASURES The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events severity classification were calculated.
Note: Known adverse effects of quadrivalent influenza vaccine that have been identified in previous clinical studies are as follows:
Inoculation site (local) adverse events: pain, induration, swelling, rash, redness, pruritus, cellulitis.
Adverse events at non-inoculated sites (systemic) included fever, diarrhea, constipation, dysphagia, anorexia, vomiting, nausea, myalgia (non-inoculated sites), arthralgia, headache, cough, dyspnea, pruritus at non-inoculated sites (without skin lesions), mucocutaneous abnormalities, irritation/inhibition, acute anaphylaxis, and fatigue/fatigue.
- Conditions
- GCP
- Being tested
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Vaccine (Split Virion), Inactivated, QuadrivalentBiological
A total of 652326 healthy children with immunization history and no immunization history aged 3-8 years who met the program requirements received two doses of normally commercially available quadrivalent influenza vaccine according to the 0,30-day procedure.
| Study group | Role | What they receive |
|---|---|---|
| There was an immunological history group | l Children who have received two or more doses of influenza vaccine (4 weeks apart) before the influenza season (2 doses of influenza vaccine do not need to be administered in the same epidemic season or consecutive epidemic season, and can be interpreted as children who have received two or more cumulative doses). Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent | |
| There was no immunological history group | l Children who have not received or previously received <2 doses of influenza vaccine before the epidemic season. Receives: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the immunogenicity of 1-dose and 2-dose schedule in 3-8 years old healthy people with and without immunization history
The lower limit of the 95% confidence interval (CI) of the seroconversion rate (SCR) of hemagglutination inhibition (HAI) antibodies against each virus strain after vaccination was ≥40%. The lowest dilution used in the assay was 1 in 10. Seroconversion was defined as a prevaccination HAI titer of <1:10 and a postvaccination titer of ≥1:40 or a prevaccination titer of ≥1:10 and a 4-fold or greater increase in titer after vaccination.
Measured: Blood samples were collected before immunization, 30 days after the first dose (before the second dose) and 30 days after the first dose for influenza virus HI antibodies.
evaluate the safety of one dose and two doses schedule in children aged 3-8 years
The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events severity classification were calculated.
Measured: The safety was observed until 6 months after the full course of immunization
Secondary outcomes (1)
Differences in antibody levels 30 days after one dose and two doses of quadrivalent influenza vaccine among healthy people aged 3-8 years with or without vaccination history.
Seroconversion rate, positive rate, GMT and GMI of HI antibody against each subtype of influenza virus were calculated 30 days after the first dose and 30 days after the second dose in the vaccination history group and non-vaccination history group, respectively. The Clopper-Pearson exact probability method was used to calculate confidence intervals for rates.
Measured: Blood samples were collected before immunization, 30 days after the first dose (before the second dose) and 30 days after the first dose for influenza virus HI antibodies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Sep 2021
- Primary completion6 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GCPStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095947
- Sponsor's protocol ID
- HL-SJLG-2021-Ⅳ-02
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Shandong Provincial Center for Disease Control and Prevention, China
- ClinicalTrials.gov ID
- NCT06095947
- Acronym / sponsor ID
- HL-SJLG-2021-Ⅳ-02
- Conditions
- GCP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 Oct 2023 (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.
The goal of this [To evaluate the immunogenicity and safety of 1 - and 2-dose schedules of quadrivalent influenza vaccine (split virion) in healthy people with and without immunization history.] is to [aged 3-8 years] in [Healthy people]. The main question[s] it aims to answer are: • [To evaluate the immunogenicity of a two-dose schedule of quadrivalent influenza vaccine (quadrivalent influenza vaccine) in healthy population aged 3-8 years with or without vaccination history.]
•[ To evaluate whether antibody levels are different 30 days after one dose of quadrivalent influenza vaccine versus two doses of quadrivalent influenza vaccine in healthy people aged 3-8 years with or without vaccination history.]
Detailed description
An open clinical trial design was used. A total of 652 healthy children aged 3-8 years, 326 with vaccination history and 326 without vaccination history, were selected to receive two doses of normal commercially available quadrivalent influenza vaccine according to a 0 -, 30-day schedule.
Immunogenicity: blood samples were collected for HI antibody detection before the first dose of influenza vaccine (before immunization), 30 days after the first dose of influenza vaccine (before the second dose of influenza vaccine) and 30 days after the second dose of influenza vaccine.
Adverse events (AE) were observed 30 minutes, 0-7 days and 8-30 days after each dose of vaccination by active follow-up combined with guardian reports. Occurrence of SAEs between 31 and 180 days after the second dose of vaccine.
Criteria for evaluation of immunogenicity According to the European Union seasonal influenza evaluation criteria, if the HI antibody seroconversion rate of each subtype of influenza virus was ≥40%, the HI antibody positive rate was ≥70%, and the GMI of each subtype of influenza virus was ≥2.5 times 30 days after any dose of vaccination, the vaccination schedule was considered to have acceptable immunogenicity.
Safety outcome MEASURES The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events severity classification were calculated.
Note: Known adverse effects of quadrivalent influenza vaccine that have been identified in previous clinical studies are as follows:
Inoculation site (local) adverse events: pain, induration, swelling, rash, redness, pruritus, cellulitis.
Adverse events at non-inoculated sites (systemic) included fever, diarrhea, constipation, dysphagia, anorexia, vomiting, nausea, myalgia (non-inoculated sites), arthralgia, headache, cough, dyspnea, pruritus at non-inoculated sites (without skin lesions), mucocutaneous abnormalities, irritation/inhibition, acute anaphylaxis, and fatigue/fatigue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| There was an immunological history group | – | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalentl Children who have received two or more doses of influenza vaccine (4 weeks apart) before the influenza season (2 doses of influenza vaccine do not need to be administered in the same epidemic season or consecutive epidemic season, and can be interpreted as children who have received two or more cumulative doses). |
| There was no immunological history group | – | Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalentl Children who have not received or previously received <2 doses of influenza vaccine before the epidemic season. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy people aged 3-8 years old
Key inclusion criteria (5 listed)
- 3-8 years old;
- The legal guardian / authorized agent gives the informed consent and voluntarily signs the informed consent to comply with the requirements of the clinical trial protocol;
- Medical history, physical examination and clinical diagnosis, who to the immunization of this product.
- children who have received two or more doses of influenza vaccine (4 weeks apart) before the season of this influenza epidemic (2 doses of influenza vaccine do not need to be vaccinated in the same epidemic season or consecutive epidemic season, but can be interpreted as children who have received two or more cumulative shots).
- History of l No immunization: children who had not been vaccinated or had previously received <2 doses of influenza vaccine before the influenza season.
Key exclusion criteria (17 listed)
- 1.1.1The exclusion criteria for the first needle To l allergic to any component of the quadrialent influenza vaccine (history of any previous vaccine allergy), especially those allergic to eggs; The l axillary body temperature was 37.5℃ before inoculation;
- Any influenza vaccine (registered or research) within 6 months prior to enrollment; or planned for use during the study period;
- Use of immunoglobulin and / or any blood products within 3 months prior to enrollment; or planned for use during the study (before blood sampling);
- Patients with a history of Guillain-Barre syndrome; l Acute disease, severe chronic disease, acute onset of chronic disease, cold;
- Uncontrolled epilepsy;
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 |
|---|---|---|
| Influenza Vaccine (Split Virion), Inactivated, QuadrivalentA total of 652326 healthy children with immunization history and no immunization history aged 3-8 years who met the program requirements received two doses of normally commercially available quadrivalent influenza vaccine according to the 0,30-day procedure. | Biological | There was an immunological history group, There was no immunological history group |
Primary outcome
evaluate the immunogenicity of 1-dose and 2-dose schedule in 3-8 years old healthy people with and without immunization history
Time frame: Blood samples were collected before immunization, 30 days after the first dose (before the second dose) and 30 days after the first dose for influenza virus HI antibodies.
The lower limit of the 95% confidence interval (CI) of the seroconversion rate (SCR) of hemagglutination inhibition (HAI) antibodies against each virus strain after vaccination was ≥40%. The lowest dilution used in the assay was 1 in 10. Seroconversion was defined as a prevaccination HAI titer of <1:10 and a postvaccination titer of ≥1:40 or a prevaccination titer of ≥1:10 and a 4-fold or greater increase in titer after vaccination.
evaluate the safety of one dose and two doses schedule in children aged 3-8 years
Time frame: The safety was observed until 6 months after the full course of immunization
The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events severity classification were calculated.
1 secondary outcome
Differences in antibody levels 30 days after one dose and two doses of quadrivalent influenza vaccine among healthy people aged 3-8 years with or without vaccination history.
Time frame: Blood samples were collected before immunization, 30 days after the first dose (before the second dose) and 30 days after the first dose for influenza virus HI antibodies.
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of GCP, run by Hualan Biological Bacterin Co. Ltd. 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 5 inclusion and 17 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 15 Sep 2025. 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.
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?
evaluate the immunogenicity of 1-dose and 2-dose schedule in 3-8 years old healthy people with and without immunization history (time frame: Blood samples were collected before immunization, 30 days after the first dose (before the second dose) and 30 days after the first dose for influenza virus HI antibodies.). 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 15 Sep 2025.