Seasonal InfluenzaPhase 4NCT04997239

A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old

A Phase 4 study testing Two doses of quadrivalent influenza vaccine and One dose of quadrivalent influenza vaccine in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Seasonal Influenza
What is being tested?: Two doses of quadrivalent influenza vaccine and One dose of quadrivalent influenza vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 1 siteChina
Study dates: 10 Oct 2021to 20 Nov 2021
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;
The subjects' guardians can understand and voluntarily sign the informed consent form;
Proven legal identity.
Healthy children aged 3-8 years;
The subjects' guardians can understand and voluntarily sign the informed consent form;
Proven legal identity;
Received at least 1 dose of seasonal influenza vaccine in previous epidemic seasons

Who cannot join

Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study;
Suffering from seasonal influenza in the past 6 moths;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Autoimmune disease or immunodeficiency / immunosuppression;
Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;

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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
History of drug abuse;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. vaccine-primed children
Received an seasonal influenza vaccine for the current epidemic season (2020-2021 epidemic season) prior to enrollment, or had an influenza vaccine schedule during the study;
Suffering from seasonal influenza in the past 6 moths;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Autoimmune disease or immunodeficiency / immunosuppression;
Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
History of drug abuse;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Huaiyin Center for Disease Control and Prevention
Huai'an, Jiangsu, 223300

Other trials in China

About this study

Official title: An Exploratory Clinical Trial to Evaluate the Immunogenicity and Safety of One vs Two Doses of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old

This is an open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.

Read the detailed description

This study is open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine.The purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.A total of 600 subjects including 400 vaccine-unprimed children and 200 vaccine-primed children will be enrolled,400 vaccine-unprimed children will be randomly divided into two groups in a 1:1 ratio.Subjects in group 1(experimental group 1 ) will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28 and subjects in group 2 (experimental group 2) will receive one dose of quadrivalent influenza vaccine.200 vaccine-primed children (experimental group 3) will receive one dose of quadrivalent influenza vaccine.

Conditions: Seasonal Influenza
Being tested: Two doses of quadrivalent influenza vaccine, One dose of quadrivalent influenza vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Two doses of quadrivalent influenza vaccineBiological
15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
One dose of quadrivalent influenza vaccineBiological
15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.

Study groups in NCT04997239
Study group	Role	What they receive
Experimental Group ：Vaccine-unprimed subjects with two doses	Experimental	200 vaccine-unprimed children will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28. Receives: Biological: Two doses of quadrivalent influenza vaccine
Experimental Group ：Vaccine-unprimed subjects with one dose	Experimental	200 vaccine-unprimed children will receive one dose of quadrivalent influenza vaccine. Receives: Biological: One dose of quadrivalent influenza vaccine
Experimental Group：Vaccine-primed subjects with one dose	Experimental	200 vaccine-primed children will receive one dose of quadrivalent influenza vaccine. Receives: Biological: One dose of quadrivalent influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Immunogenicity index of the seroconversion rate
The seroconversion rate of each influenza strain after each dose of quadrivalent influenza vaccine
Measured: 28 days after the vaccination of the last dose
Immunogenicity index of the seroprotective rate
The seroprotective rate of each influenza strain after each dose of quadrivalent influenza vaccine
Measured: 28 days after the vaccination of the last dose
Immunogenicity index of the GMT
The GMT of each influenza strain after each dose of quadrivalent influenza vaccine
Measured: 28 days after the vaccination of the last dose
Immunogenicity index of the GMI
The GMI of each influenza strain after each dose of quadrivalent influenza vaccine
Measured: 28 days after the vaccination of the last dose
Safety index of the incidence of adverse reactions
The incidence of adverse reactions within 0-7 days after each dose
Measured: From day 0 to day 7 after each dose vaccination
Safety index of the incidence of adverse reactions
The incidence of adverse reactions within 0-28 days after each dose
Measured: From day 0 to day 28 after each dose vaccination
Safety index of the incidence of serious adverse events(SAEs)
The incidence of serious adverse events from the beginning of vaccination to 28 days after the last dose
Measured: From the beginning of the vaccination to 28 days after the whole-schedule vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202120 Nov 2021

First posted9 Aug 2021
Study start10 Oct 2021
Primary completion30 Oct 2021
Study completion20 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
More trials run by Sinovac Biotech Co., LtdThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04997239
Sponsor's protocol ID: PRO-QINF-4002
Status last verified: Jul 2021
First submitted: 2 Aug 2021
Last updated: 11 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Seasonal Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Clinical Trial to Evaluate the Immunogenicity and Safety of One vs Two Doses of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old
ClinicalTrials.gov ID: NCT04997239
Acronym / sponsor ID: PRO-QINF-4002
Conditions: Seasonal Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
Study start: 10 Oct 2021 (actual)
Primary completion: 30 Oct 2021 (actual)
Study completion: 20 Nov 2021 (actual)
First posted: 9 Aug 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Experimental Group ：Vaccine-unprimed subjects with two doses	Experimental	Biological: Two doses of quadrivalent influenza vaccine200 vaccine-unprimed children will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28.
Experimental Group ：Vaccine-unprimed subjects with one dose	Experimental	Biological: One dose of quadrivalent influenza vaccine200 vaccine-unprimed children will receive one dose of quadrivalent influenza vaccine.
Experimental Group：Vaccine-primed subjects with one dose	Experimental	Biological: One dose of quadrivalent influenza vaccine200 vaccine-primed children will receive one dose of quadrivalent influenza vaccine.

Who may qualify

Ages: 3 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Healthy children aged 3-8 years;
The subjects' guardians can understand and voluntarily sign the informed consent form;
Proven legal identity.
Healthy children aged 3-8 years;
The subjects' guardians can understand and voluntarily sign the informed consent form;

Key exclusion criteria (35 listed)

Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study;
Suffering from seasonal influenza in the past 6 moths;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Autoimmune disease or immunodeficiency / immunosuppression;

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
Two doses of quadrivalent influenza vaccine15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.	Biological	Experimental Group ：Vaccine-unprimed subjects with two doses
One dose of quadrivalent influenza vaccine15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.	Biological	Experimental Group ：Vaccine-unprimed subjects with one dose, Experimental Group：Vaccine-primed subjects with one dose

Primary outcome

Immunogenicity index of the seroconversion rate
Time frame: 28 days after the vaccination of the last dose
The seroconversion rate of each influenza strain after each dose of quadrivalent influenza vaccine
Immunogenicity index of the seroprotective rate
Time frame: 28 days after the vaccination of the last dose
The seroprotective rate of each influenza strain after each dose of quadrivalent influenza vaccine
Immunogenicity index of the GMT
Time frame: 28 days after the vaccination of the last dose
The GMT of each influenza strain after each dose of quadrivalent influenza vaccine
Immunogenicity index of the GMI
Time frame: 28 days after the vaccination of the last dose
The GMI of each influenza strain after each dose of quadrivalent influenza vaccine
Safety index of the incidence of adverse reactions
Time frame: From day 0 to day 7 after each dose vaccination
The incidence of adverse reactions within 0-7 days after each dose
Safety index of the incidence of adverse reactions
Time frame: From day 0 to day 28 after each dose vaccination
The incidence of adverse reactions within 0-28 days after each dose
Safety index of the incidence of serious adverse events(SAEs)
Time frame: From the beginning of the vaccination to 28 days after the whole-schedule vaccination
The incidence of serious adverse events from the beginning of vaccination to 28 days after the last dose

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 11 Aug 2022.

Related trials for Seasonal Influenza

RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Seasonal Influenza
Not yet recruitingPhase 1
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
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Not yet recruitingPhase 4
A Study of Updated mRNA Seasonal Influenza Vaccines
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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.

Hongxing Pan, Master principal investigator

Jiangsu Provincial Center for Disease Prevention and Control

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 35 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 11 Aug 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?

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?

Immunogenicity index of the seroconversion rate (time frame: 28 days after the vaccination of the last dose). 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?

On the ClinicalTrials.gov record for NCT04997239.

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 11 Aug 2022.