Seasonal InfluenzaPhase 3NCT05245552
A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
A Phase 3 study testing Quadrivalent influenza vaccine(0.25ml), Quadrivalent influenza vaccine(0.5ml) and Trivalent influenza vaccine(BV) in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 4 sites in China.
Trial summary
The study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to… Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Quadrivalent influenza vaccine(0.25ml), Quadrivalent influenza vaccine(0.5ml) and Trivalent influenza vaccine(BV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 4 sitesChina
- Study dates
- 8 Aug 2022to 4 Aug 2023
- Phase
- Phase 3
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged 6-35 months;
- Proven vaccination certificate and birth certificate;
- The subjects' guardians can understand and voluntarily sign the informed consent form.
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;
- Axillary temperature >37.0°C;
- 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.;
- Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia or neurological disorders);
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- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Autoimmune disease or immunodeficiency / immunosuppression;
- 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;
- Acute diseases or acute exacerbation of chronic diseases in the past 3 days;
- 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;
- Participated in other clinical trials before enrollment and in the follow-up period, or plans to participate in other clinical trials during the clinical trial;
- 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
4 sites in 1 country.
China4 sites
Huaiyin Center for Diseases Control and Prevention
Huai'an, Jiangsu, 223300
Ganyu District Center for Disease Control and Prevention
Lianyungang, Jiangsu, 222100
Donghai District Center for Disease Prevention and Control
Lianyungang, Jiangsu, 222300
Binhai District Center for Disease Control and Prevention
Yancheng, Jiangsu, 224500
About this study
Official title: An Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months.
The study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged 6 to 35 months.
Read the detailed description
This study of quadrivalent influenza vaccine will be open-label design in phase Ⅰ and randomized, double-blind, active controlled design in phase III.The quadrivalent influenza vaccine was manufactured by Sinovac Biotech Co., Ltd.
The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine(0.25ml and 0.5ml) manufactured by Sinovac Biotech Co., Ltd in healthy infants aged from 6 to 35 months. A total of 3330 subjects including 30 subjects in phase Ⅰ and 3300 subjects in phase III will be enrolled. The subjects in phase Ⅰ will receive 2 doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.The subjects in phase III will be randomly assigned to 4 groups in a 2:2:1:1 ratio and subjects will receive two doses of quadrivalent influenza vaccine(0.25ml or 0.5ml) or trivalent influenza vaccine(BV or BY), respectively,on the immunization schedule of day 0,28 in each group.
- Conditions
- Seasonal Influenza
- Being tested
- Quadrivalent influenza vaccine(0.25ml), Quadrivalent influenza vaccine(0.5ml), Trivalent influenza vaccine(BV), Trivalent influenza vaccine(BY)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent influenza vaccine(0.25ml)Biological
7.5 ug hemagglutinin (HA) of each of the four influenza strains in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
Quadrivalent influenza vaccine(0.5ml)Biological
15 ug 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 administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
Trivalent influenza vaccine(BV)Biological
7.5μg inactivated influenza antigen (H1N1, H3N2, Victoria) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
Trivalent influenza vaccine(BY)Biological
7.5μg inactivated influenza antigen (H1N1, H3N2, and Yamagata) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
| Study group | Role | What they receive |
|---|---|---|
| Safety group | Experimental | PhaseⅠ,30 subjects will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28. Receives: Biological: Quadrivalent influenza vaccine(0.25ml) |
| Experimental Group of quadrivalent influenza vaccine(0.25ml) | Experimental | 1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) on the immunization schedule of day 0,28. Receives: Biological: Quadrivalent influenza vaccine(0.25ml) |
| Experimental Group of quadrivalent influenza vaccine(0.5ml) | Experimental | 1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28. Receives: Biological: Quadrivalent influenza vaccine(0.5ml) |
| Control Group of trivalent influenza vaccine(BV) | Active comparator | 550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) on the immunization schedule of day 0,28. Receives: Biological: Trivalent influenza vaccine(BV) |
| Control Group of trivalent influenza vaccine(BY) | Active comparator | 550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) on the immunization schedule of day 0,28. Receives: Biological: Trivalent influenza vaccine(BY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index of seroconversion rate
HI antibody seroconversion rate 28 days after full schedule immunization
Measured: 28 days after full schedule immunization
Immunogenicity index of seroprotection rate
HI antibody seroprotection rate 28 days after full schedule immunization
Measured: 28 days after full schedule immunization
Immunogenicity index of GMT
HI antibody GMT increase folds 28 days after full schedule immunization
Measured: 28 days after full schedule immunization
Safety index of the incidence of adverse reaction
Incidence of adverse reaction 0-28 days after each dose
Measured: 0-28 days after each dose
Safety index of the incidence of adverse reaction
Incidence of adverse reaction 0-7 days after each dose
Measured: 0-7 days after each dose
Safety index of the incidence of abnormal blood biochemical indexes
The incidence of abnormal blood biochemical indexes 3 days after each dose
Measured: 3 days after each dose
Safety index of the incidence of SAE
Incidence of SAE since the beginning of vaccination until 6 months after full course vaccination
Measured: Since the beginning of vaccination until 6 months after full course vaccination
Secondary outcomes (1)
Safety index of the incidence of AESI
Incidence of AESI since the beginning of vaccination until 6 months after full course vaccination
Measured: Since the beginning of vaccination until 6 months after full course vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start8 Aug 2022
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongxing Pan, Master, Principal investigator, Jiangsu Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245552
- Sponsor's protocol ID
- PRO-QINF-3003
- Status last verified
- May 2024
- First submitted
- 8 Feb 2022
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months.
- ClinicalTrials.gov ID
- NCT05245552
- Acronym / sponsor ID
- PRO-QINF-3003
- Conditions
- Seasonal Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 18 Feb 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.
The study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged 6 to 35 months.
Detailed description
This study of quadrivalent influenza vaccine will be open-label design in phase Ⅰ and randomized, double-blind, active controlled design in phase III.The quadrivalent influenza vaccine was manufactured by Sinovac Biotech Co., Ltd.
The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine(0.25ml and 0.5ml) manufactured by Sinovac Biotech Co., Ltd in healthy infants aged from 6 to 35 months. A total of 3330 subjects including 30 subjects in phase Ⅰ and 3300 subjects in phase III will be enrolled. The subjects in phase Ⅰ will receive 2 doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.The subjects in phase III will be randomly assigned to 4 groups in a 2:2:1:1 ratio and subjects will receive two doses of quadrivalent influenza vaccine(0.25ml or 0.5ml) or trivalent influenza vaccine(BV or BY), respectively,on the immunization schedule of day 0,28 in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Safety group | Experimental | Biological: Quadrivalent influenza vaccine(0.25ml)PhaseⅠ,30 subjects will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28. |
| Experimental Group of quadrivalent influenza vaccine(0.25ml) | Experimental | Biological: Quadrivalent influenza vaccine(0.25ml)1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) on the immunization schedule of day 0,28. |
| Experimental Group of quadrivalent influenza vaccine(0.5ml) | Experimental | Biological: Quadrivalent influenza vaccine(0.5ml)1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28. |
| Control Group of trivalent influenza vaccine(BV) | Active comparator | Biological: Trivalent influenza vaccine(BV)550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) on the immunization schedule of day 0,28. |
| Control Group of trivalent influenza vaccine(BY) | Active comparator | Biological: Trivalent influenza vaccine(BY)550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) on the immunization schedule of day 0,28. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants aged 6-35 months;
- Proven vaccination certificate and birth certificate;
- The subjects' guardians can understand and voluntarily sign the informed consent form.
Key exclusion criteria (18 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;
- Axillary temperature >37.0°C;
- 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.;
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 vaccine(0.25ml)7.5 ug hemagglutinin (HA) of each of the four influenza strains in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28. | Biological | Experimental Group of quadrivalent influenza vaccine(0.25ml), Safety group |
| Quadrivalent influenza vaccine(0.5ml)15 ug 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 administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28. | Biological | Experimental Group of quadrivalent influenza vaccine(0.5ml) |
| Trivalent influenza vaccine(BV)7.5μg inactivated influenza antigen (H1N1, H3N2, Victoria) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28. | Biological | Control Group of trivalent influenza vaccine(BV) |
| Trivalent influenza vaccine(BY)7.5μg inactivated influenza antigen (H1N1, H3N2, and Yamagata) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28. | Biological | Control Group of trivalent influenza vaccine(BY) |
Primary outcome
Immunogenicity index of seroconversion rate
Time frame: 28 days after full schedule immunization
HI antibody seroconversion rate 28 days after full schedule immunization
Immunogenicity index of seroprotection rate
Time frame: 28 days after full schedule immunization
HI antibody seroprotection rate 28 days after full schedule immunization
Immunogenicity index of GMT
Time frame: 28 days after full schedule immunization
HI antibody GMT increase folds 28 days after full schedule immunization
Safety index of the incidence of adverse reaction
Time frame: 0-28 days after each dose
Incidence of adverse reaction 0-28 days after each dose
Safety index of the incidence of adverse reaction
Time frame: 0-7 days after each dose
Incidence of adverse reaction 0-7 days after each dose
Safety index of the incidence of abnormal blood biochemical indexes
Time frame: 3 days after each dose
The incidence of abnormal blood biochemical indexes 3 days after each dose
Safety index of the incidence of SAE
Time frame: Since the beginning of vaccination until 6 months after full course vaccination
Incidence of SAE since the beginning of vaccination until 6 months after full course vaccination
1 secondary outcome
Safety index of the incidence of AESI
Time frame: Since the beginning of vaccination until 6 months after full course vaccination
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 28 May 2024.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent influenza vaccine(0.25ml), Quadrivalent influenza vaccine(0.5ml) and Trivalent influenza vaccine(BV) in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 4 sites 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 18 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 seroconversion rate (time frame: 28 days after full schedule immunization). 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 28 May 2024.