Influenza, HumanPhase 4NCT05138705
Clinical Trial of Quadrivalent Influenza Virus Split Vaccine in Population Aged 3-8 Years
A Phase 4 study testing Quadrivalent Influenza Virus Split Vaccine in people with Influenza, Human, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Quadrivalent Influenza Virus Split Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2021to 5 Aug 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
- Healthy children aged 3-8 years. Volunteers are required to show vaccination certificate if they have not received a previous flu vaccine.
- Volunteers' legal guardian or client informed consent, voluntarily participate in and sign informed consent. (Volunteers over the age of 8 also need informed consent and signature)
- Volunteers' legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.
Who cannot join
- The axillary temperature greater than 37.0℃ on the day of enrollment;
- Have suffered from influenza within previous 3 months or suffering currently (confirmed by either clinical, serological or microbiological methods);
- Have received any influenza vaccine (registered or experimental) within 6 months or be going to receive other influenza vaccine during the study period;
- Allergic to any component of the vaccine, or have a history of allergic reactions to gentamicin sulfate;
- A history of severe allergy to any vaccine or drug, or with a history of nervous system damage;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
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- Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
- A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
- Received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
- Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- Have a history of asthma, the condition has been unstable for past two years and require treatment, such as emergency treatment, hospitalization, intubation or oral or intravenous administration of corticosteroids and so on;
- Have received blood or blood-related products;
- A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or have a mental illness family history;
- A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
- Planning to relocate before the end of the study or to leave for an extended period during the scheduled study visit;
- Participating in or planning to participate in other clinical trials in the near future;
- Any conditions judged by investigators that were inappropriate for participation in this clinical trial.
- Receiving the second dose of vaccine
- Have a severe allergic reaction after receiving the first dose of vaccine;
- Serious adverse events occurred that were causally related to the first dose of vaccine injection；
- After receiving the first dose of vaccine, the researchers will decide whether the volunteer should participate in the study continued or not if the newly discovered feature or newly condition occurred on volunteer that do not meet the inclusion criteria or meet the exclusion criteria;
- Other reasons for exclusion considered by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Phase IV Clinical Trial of Quadrivalent Influenza Virus Split Vaccine to Evaluate the Safety and Immunogenicity in Healthy Population Aged 3-8 Years
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures.
Read the detailed description
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures, and the participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at day 0 and 28.
- Conditions
- Influenza, Human
- Being tested
- Quadrivalent Influenza Virus Split Vaccine
- Keywords
- QIV, safety, immunogenicity
- 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 Split VaccineBiological
0.5ml Quadrivalent influenza vaccine The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/ H3N2, B/Victoria and B/Yamagata strains
| Study group | Role | What they receive |
|---|---|---|
| Outcome | Experimental | Quadrivalent influenza vaccine Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28. Receives: Biological: Quadrivalent Influenza Virus Split Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion rate of hemagglutination inhibition (HI) antibodies
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroconversion rate of HI antibodies against any subtype of influenza virus in each group.
Measured: up to 56 days
seroprotection rate of HI antibodies
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroprotection rate of HI antibodies against any subtype of influenza virus in each group.
Measured: up to 56 days
geometric mean increase (GMI) of HI antibodies
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. GMI of HI antibodies against any subtype of influenza virus in each group.
Measured: up to 56 days
The proportion of all adverse reactions/events
The proportion of all adverse reactions/events in subjects through 28 days after the second dose.
Measured: up to 56 days
Secondary outcomes (4)
p value of difference of seroconversion rate in subjects with different immunization procedures
p value of the difference of seroconversion rate of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two.
Measured: up to 56 days
p value of difference of seroprotection rate in subjects with different immunization procedures
p value of the difference of seroprotection rate of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two.
Measured: up to 56 days
p value of difference of GMI in subjects with different immunization procedures
p value of the difference of GMI of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two.
Measured: up to 56 days
Reactogenicity Events
The proportion of all adverse reactions/events in subjects from the day subjects receiving the first dose of vaccine to 180 days after subjects receiving the second dose.
Measured: 208 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start14 Dec 2021
- Primary completion28 Feb 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- 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 in one group received a first and a second dose of the vaccine at different time points.
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Principal investigator, Shandong Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138705
- Sponsor's protocol ID
- 2021S00207-01
- Status last verified
- Nov 2021
- First submitted
- 28 Nov 2021
- Last updated
- 14 Aug 2023
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase IV Clinical Trial of Quadrivalent Influenza Virus Split Vaccine to Evaluate the Safety and Immunogenicity in Healthy Population Aged 3-8 Years
- ClinicalTrials.gov ID
- NCT05138705
- Acronym / sponsor ID
- 2021S00207-01
- Conditions
- Influenza, Human
- Keywords
- QIV, safety, immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 1 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.
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures.
Detailed description
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures, and the participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at day 0 and 28.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects in one group received a first and a second dose of the vaccine at different time points.
| Arm | Type | Receives |
|---|---|---|
| Outcome | Experimental | Biological: Quadrivalent Influenza Virus Split VaccineQuadrivalent influenza vaccine Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children aged 3-8 years. Volunteers are required to show vaccination certificate if they have not received a previous flu vaccine.
- Volunteers' legal guardian or client informed consent, voluntarily participate in and sign informed consent. (Volunteers over the age of 8 also need informed consent and signature)
- Volunteers' legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.
Key exclusion criteria (22 listed)
- The axillary temperature greater than 37.0℃ on the day of enrollment;
- Have suffered from influenza within previous 3 months or suffering currently (confirmed by either clinical, serological or microbiological methods);
- Have received any influenza vaccine (registered or experimental) within 6 months or be going to receive other influenza vaccine during the study period;
- Allergic to any component of the vaccine, or have a history of allergic reactions to gentamicin sulfate;
- A history of severe allergy to any vaccine or drug, or with a history of nervous system 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 Virus Split Vaccine0.5ml Quadrivalent influenza vaccine The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/ H3N2, B/Victoria and B/Yamagata strains | Biological | Outcome |
Primary outcome
seroconversion rate of hemagglutination inhibition (HI) antibodies
Time frame: up to 56 days
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroconversion rate of HI antibodies against any subtype of influenza virus in each group.
seroprotection rate of HI antibodies
Time frame: up to 56 days
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroprotection rate of HI antibodies against any subtype of influenza virus in each group.
geometric mean increase (GMI) of HI antibodies
Time frame: up to 56 days
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. GMI of HI antibodies against any subtype of influenza virus in each group.
The proportion of all adverse reactions/events
Time frame: up to 56 days
The proportion of all adverse reactions/events in subjects through 28 days after the second dose.
4 secondary outcomes
p value of difference of seroconversion rate in subjects with different immunization procedures
Time frame: up to 56 days
p value of difference of seroprotection rate in subjects with different immunization procedures
Time frame: up to 56 days
p value of difference of GMI in subjects with different immunization procedures
Time frame: up to 56 days
Reactogenicity Events
Time frame: 208 days
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 14 Aug 2023.
- 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.
Li Zhang principal investigator
Shandong Provincial Center 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 Virus Split Vaccine in people with Influenza, Human, run by Shanghai Institute Of Biological Products 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 3 inclusion and 22 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 14 Aug 2023. 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?
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?
seroconversion rate of hemagglutination inhibition (HI) antibodies (time frame: up to 56 days). The study lists 4 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 14 Aug 2023.