InfluenzaPhase 4QIVNCT05389137
To Identify the Immunogenicity and Safety of QIV in Children Aged 3-8 Years
A Phase 4 study testing Inavtivated Quadrivalent Influenza Virus Split Vaccine in people with Influenza, run by Wuhan Institute of Biological Products Co., Ltd at 1 site in China.
Trial summary
To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study. 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?
- Inavtivated Quadrivalent Influenza Virus Split Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2022to Oct 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
- At the age of 3 years old and below 9 years old on the day of enrollment, valid identification of the subject and/or his/her guardian can be provided;
- The subject's guardian has the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent (8-year-old subject: The subject and his/her guardian voluntarily agree to participate in the study, and the informed consent shall be signed by his/her guardian and the subject shall sign the informed consent for minors; Subjects aged 3-7: The guardian of the subject voluntarily agrees that the child should participate in the study, and the guardian should sign the informed consent);
- The subject's guardian is competent to understand the study procedures, and the subject and/or his/her guardian are able to attend all planned follow-up visits;
- Axillary temperature on the day of enrollment < 37.5℃.
Who cannot join
- Have a history of severe allergy to any components of the test vaccine (including eggs and ovalbumin, etc.), such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthus reaction);
- patients with influenza or influenza-like symptoms within 3 months (fever < axillary temperature ≥38℃ >, accompanied by cough or sore throat);
- Have any history of serious adverse reactions to vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angoneeurotic edema, etc., which are deemed unsuitable for inclusion by researchers;
- Patients with acute diseases or acute episodes of chronic diseases within 3 days before vaccination;
- Before enrollment, the interval between other inactivated vaccines was less than 7 days, and the interval between live attenuated vaccines was less than 14 days;
- Fever or antipyretic analgesics and antiallergic drugs were used in the first 3 days before enrollment;
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- Long-term use of immunosuppressants or other immunomodulatory drugs within 3 months prior to enrollment (defined as continuous use for more than 14 days), such as glucocorticoid dose ≥0.5mg/kg/ day (inhalation and local glucocorticoid are not restricted);
- Received blood or blood related products 6 months before enrollment;
- have been diagnosed with congenital or acquired immunodeficiency;
- done with may interfere with study or severe disease or congenital malformations (including but not limited to, the researchers determine unfavorable into groups: respiratory diseases such as asthma or chronic bronchitis attack, down syndrome, during the Mediterranean anemia, heart disease, kidney disease, autoimmune diseases, genetic allergic constitution, GBS, skin diseases, etc.);
- have been diagnosed with a systemic disease that may interfere with the conduct or completion of the study, such as tuberculosis, viral hepatitis, and/or human immunodeficiency virus HIV infection, as determined by the investigator to be ineligible for inclusion;
- History or family history of convulsions, epilepsy, encephalopathy and mental illness;
- There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment;
- absence of spleen, functional absence of spleen, and absence of spleen or splenectomy resulting from any circumstance;
- Plan to move out of the local area before the end of the study or leave the area for an extended period during the scheduled study visit;
- The investigator considers that the subject has any conditions that might interfere with the evaluation of the study purpose.
- The second dose delayed the standard of inoculation If any of the following occurs, the researchers will delay vaccination until the situation abates.
- Fever (axillary temperature ≥37.5℃ at visit);
- Acute illness or acute episode of chronic disease (within 3 days prior to vaccination);
- Insufficient interval between other vaccines (less than 7 days between inactivated vaccines and less than 14 days between live attenuated vaccines);
- Any other reasons that the investigator assessed to be necessary to delay trial vaccination.
- Exclusion criteria for the second dose The investigator will discontinue the subject's trial vaccine if any of the following occurs.
- New discoveries or occurrences that meet the criteria for the first exclusion prior to vaccination (other than postponement of the criteria);
- Adverse reactions (including but not limited to) after vaccination (experimental vaccine);
- appears within 48 hours after inoculation:
- High fever (axillary temperature ≥39.5°C), with or without convulsion;
- appears after experimental vaccine is administered:
- encephalopathy;
- Seizures.
- Other serious adverse events: decide whether to discontinue trial vaccine based on their treatment needs;
- Any other reasons the investigator assessed to be necessary to discontinue trial vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site
Yangchun Center for Disease Control and Prevention
Guangzhou, Guangdong
About this study
Official title: To Identify the Immunogenicity and Safety of Inavtivated Quadrivalent Influenza Virus Split Vaccine in Children Aged 3-8 Years With Two Doses and One Dose Pre-immunization
To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study.
Sample size and test grouping:
Read more
In this study, a total of 360 subjects were enrolled in a self-controlled trial design.
In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group.
All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.
Read the detailed description
Sample size and test grouping:
In this study, a total of 360 subjects were enrolled in a self-controlled trial design.
In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group.
All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.
The enrollment sequence of this study is divided into two stages:
First stage: group 1, group 2 and group 3 into the group of 20 people, each agent 1 test vaccine respectively, collecting agent 1 test vaccine adverse event, within 7 days after 8 days after 1 dose diary collection card security assessment, confirm safe (not to suspend/terminate the test standard), can be on to the next stage into the group; The second dose of the trial vaccine was administered, adverse events were collected within 7 days after the second dose of the trial vaccine, diary cards were collected for safety assessment 8 days after the second dose, and the next phase of the second dose of vaccine could be administered after the safety was confirmed (criteria for suspension/termination of the trial were not met);
The second stage: The remaining 100 subjects in experimental groups 1, 2 and 3 were inoculated with the first and second doses of experimental vaccine.
Blood collection procedure:
About 4.0ml of venous blood was collected from all subjects before each dose and 30 days after the second dose.
- Conditions
- Influenza
- Being tested
- Inavtivated Quadrivalent Influenza Virus Split 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.
Inavtivated Quadrivalent Influenza Virus Split VaccineBiological
Prevent influenza caused by H1N1, H3N2, B (V), B (Y) strain virus infection.
| Study group | Role | What they receive |
|---|---|---|
| Trial group 1 (No previous influenza vaccination) | Other | Subjects with no previous influenza vaccination Receives: Biological: Inavtivated Quadrivalent Influenza Virus Split Vaccine |
| Trial group 2 (previous vaccinated with one dose of influenza vaccine) | Other | Subjects previously vaccinated with one dose of influenza vaccine Receives: Biological: Inavtivated Quadrivalent Influenza Virus Split Vaccine |
| Trial group 2 (previous vaccinated with two doses of influenza vaccine) | Other | Subjects previously vaccinated with two dose of influenza vaccine Receives: Biological: Inavtivated Quadrivalent Influenza Virus Split Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion Rate (SCR)
Seroconversion Rate (SCR) of HI antibodies of 4 vaccine strain types in all subjects
Measured: 28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.
Seroprotection Rate (SPR)
Seroprotection Rate (SPR) of HI antibodies of 4 vaccine types in all subjects
Measured: 28 days after the first dose of trial vaccine, 30 days after the second dose of trial vaccine.
Geometric Mean Titer
Geometric Mean Titer of HI antibodies of 4 vaccine types in all subjects
Measured: 28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.
Incidence of adverse reactions
Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
Measured: Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
Incidence of all adverse events
- Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
Measured: • Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
Incidence of all serious adverse events
Incidence of all serious adverse events from the first dose to 6 months after full vaccination;
Measured: Incidence of all serious adverse events from the first dose to 6 months after full vaccination;
Incidence of AE/SAE leading to withdrawal.
Incidence of AE/SAE leading to withdrawal.
Measured: Incidence of AE/SAE leading to withdrawal within seven month during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start2 Mar 2022
- Primary completionMay 2022 (estimated)
- Study completionOct 2022 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study.
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jikai Zhang, Principal investigator, Guangdong province institute of biologicals and materia medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389137
- Sponsor's protocol ID
- WIBP2021007
- Acronym
- QIV
- Status last verified
- May 2022
- First submitted
- 14 Apr 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only for the objective of this study.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Identify the Immunogenicity and Safety of Inavtivated Quadrivalent Influenza Virus Split Vaccine in Children Aged 3-8 Years With Two Doses and One Dose Pre-immunization
- ClinicalTrials.gov ID
- NCT05389137
- Acronym / sponsor ID
- QIV / WIBP2021007
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Wuhan Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 25 May 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.
To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study.
Sample size and test grouping:
In this study, a total of 360 subjects were enrolled in a self-controlled trial design.
In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group.
All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.
Detailed description
Sample size and test grouping:
In this study, a total of 360 subjects were enrolled in a self-controlled trial design.
In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group.
All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.
The enrollment sequence of this study is divided into two stages:
First stage: group 1, group 2 and group 3 into the group of 20 people, each agent 1 test vaccine respectively, collecting agent 1 test vaccine adverse event, within 7 days after 8 days after 1 dose diary collection card security assessment, confirm safe (not to suspend/terminate the test standard), can be on to the next stage into the group; The second dose of the trial vaccine was administered, adverse events were collected within 7 days after the second dose of the trial vaccine, diary cards were collected for safety assessment 8 days after the second dose, and the next phase of the second dose of vaccine could be administered after the safety was confirmed (criteria for suspension/termination of the trial were not met);
The second stage: The remaining 100 subjects in experimental groups 1, 2 and 3 were inoculated with the first and second doses of experimental vaccine.
Blood collection procedure:
About 4.0ml of venous blood was collected from all subjects before each dose and 30 days after the second dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study.
| Arm | Type | Receives |
|---|---|---|
| Trial group 1 (No previous influenza vaccination) | Other | Biological: Inavtivated Quadrivalent Influenza Virus Split VaccineSubjects with no previous influenza vaccination |
| Trial group 2 (previous vaccinated with one dose of influenza vaccine) | Other | Biological: Inavtivated Quadrivalent Influenza Virus Split VaccineSubjects previously vaccinated with one dose of influenza vaccine |
| Trial group 2 (previous vaccinated with two doses of influenza vaccine) | Other | Biological: Inavtivated Quadrivalent Influenza Virus Split VaccineSubjects previously vaccinated with two dose of influenza vaccine |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- At the age of 3 years old and below 9 years old on the day of enrollment, valid identification of the subject and/or his/her guardian can be provided;
- The subject's guardian has the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent (8-year-old subject: The subject and his/her guardian voluntarily agree to participate in the study, and the informed consent shall be signed by his/her guardian and the subject shall sign the informed consent for minors; Subjects aged 3-7: The guardian of the subject voluntarily agrees that the child should participate in the study, and the guardian should sign the informed consent);
- The subject's guardian is competent to understand the study procedures, and the subject and/or his/her guardian are able to attend all planned follow-up visits;
- Axillary temperature on the day of enrollment < 37.5℃.
Key exclusion criteria (31 listed)
- Have a history of severe allergy to any components of the test vaccine (including eggs and ovalbumin, etc.), such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthus reaction);
- patients with influenza or influenza-like symptoms within 3 months (fever < axillary temperature ≥38℃ >, accompanied by cough or sore throat);
- Have any history of serious adverse reactions to vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angoneeurotic edema, etc., which are deemed unsuitable for inclusion by researchers;
- Patients with acute diseases or acute episodes of chronic diseases within 3 days before vaccination;
- Before enrollment, the interval between other inactivated vaccines was less than 7 days, and the interval between live attenuated vaccines was less than 14 days;
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 |
|---|---|---|
| Inavtivated Quadrivalent Influenza Virus Split VaccinePrevent influenza caused by H1N1, H3N2, B (V), B (Y) strain virus infection. | Biological | Trial group 1 (No previous influenza vaccination), Trial group 2 (previous vaccinated with one dose of influenza vaccine), Trial group 2 (previous vaccinated with two doses of influenza vaccine) |
Primary outcome
Seroconversion Rate (SCR)
Time frame: 28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.
Seroconversion Rate (SCR) of HI antibodies of 4 vaccine strain types in all subjects
Seroprotection Rate (SPR)
Time frame: 28 days after the first dose of trial vaccine, 30 days after the second dose of trial vaccine.
Seroprotection Rate (SPR) of HI antibodies of 4 vaccine types in all subjects
Geometric Mean Titer
Time frame: 28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.
Geometric Mean Titer of HI antibodies of 4 vaccine types in all subjects
Incidence of adverse reactions
Time frame: Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
Incidence of all adverse events
Time frame: • Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
• Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
Incidence of all serious adverse events
Time frame: Incidence of all serious adverse events from the first dose to 6 months after full vaccination;
Incidence of all serious adverse events from the first dose to 6 months after full vaccination;
Incidence of AE/SAE leading to withdrawal.
Time frame: Incidence of AE/SAE leading to withdrawal within seven month during the study period
Incidence of AE/SAE leading to withdrawal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No. only for the objective of this study.
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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.
Jikai Zhang principal investigator
Guangdong province institute of biologicals and materia medica
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 Inavtivated Quadrivalent Influenza Virus Split Vaccine in people with Influenza, run by Wuhan Institute of Biological Products 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 4 inclusion and 31 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 25 May 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?
Seroconversion Rate (SCR) (time frame: 28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.). The study lists 7 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 25 May 2022.