InfluenzaPhase 4NCT05313893
A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
A Phase 4 study testing Quadrivalent influenza vaccine in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. 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?
- Quadrivalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2021to 30 May 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
- Aged 3-8 years old
- Healthy subjects judged from medical history and clinical examination
- Subjects themselves or their guardians able to understand and sign theinformed consent
- Subjects themselves or their guardians can and will comply with therequirements of the protocol
- Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
- Subjects with temperature <=37.0°C on axillary setting
Who cannot join
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of influenza vaccine in last 6 month
- Any prior administration of immunodepressant or corticosteroids in last 3 months
- Any prior administration of blood products in last 3 months
- Any prior administration of any attenuated live vaccine in last 14 days
- Any prior administration of subunit or inactivated vaccines in last 7 days
Show all 14Show fewer
- Subject who developed guillain-Barre syndrome post influenza vaccination
- Subject who is allergic to any ingredient of the vaccine
- Subject with acute febrile illness or infectious disease
- Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection
- Subject with damaged or low immune function which has already beenknown
- Subject with congenital heart disease or other birth defects unsuitable for vaccination.
- Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.
- Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol
Trial locations and contacts
1 site in 1 country.
China1 site
Donghai County Center for Disease Control and Prevention
Lianyungang, Jiangsu, 222300
About this study
Official title: A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years
Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.
Read the detailed description
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint
- Conditions
- Influenza
- Being tested
- Quadrivalent influenza vaccine
- Keywords
- Safety, Immunogenicity, Quadrivalent influenza 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.
Quadrivalent influenza vaccineBiological
Subjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.
| Study group | Role | What they receive |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Subjects received 2 doses of 0.5 mL of quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain. Receives: Biological: Quadrivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40%
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Measured: day 28 after dose 2
Number of participants with Adverse Reactions (ARs)
Frequency and severity of ARs for 28 days after each vaccination
Measured: 28 days after each vaccination
Secondary outcomes (4)
the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
Measured: day 28 after dose 2
Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5
Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI)against each virus strain
Measured: day 28 after dose 2
Number of participants with Adverse Events (AEs)
Frequency and severity of AEs for 28 days after each vaccination
Measured: 28 days after each vaccination
Number of participants with Serious Adverse Events (SAE)
Frequency of SAEs for 6 months after the last vaccination
Measured: 6 months after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start11 Sep 2021
- Primary completion25 Dec 2021
- Study completion30 May 2022
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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects received 2 doses of an inactivated quadrivalent influenza vaccine,4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and4 weeks after dose 2.
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313893
- Sponsor's protocol ID
- SJLGYM-2021-Ⅳ-01
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 17 Aug 2022
- 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years
- ClinicalTrials.gov ID
- NCT05313893
- Acronym / sponsor ID
- SJLGYM-2021-Ⅳ-01
- Conditions
- Influenza
- Keywords
- Safety, Immunogenicity, Quadrivalent influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 6 Apr 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.
Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.
Detailed description
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects received 2 doses of an inactivated quadrivalent influenza vaccine,4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and4 weeks after dose 2.
| Arm | Type | Receives |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Biological: Quadrivalent influenza vaccineSubjects received 2 doses of 0.5 mL of quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 3-8 years old
- Healthy subjects judged from medical history and clinical examination
- Subjects themselves or their guardians able to understand and sign theinformed consent
- Subjects themselves or their guardians can and will comply with therequirements of the protocol
- Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
Key exclusion criteria (14 listed)
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of influenza vaccine in last 6 month
- Any prior administration of immunodepressant or corticosteroids in last 3 months
- Any prior administration of blood products in last 3 months
- Any prior administration of any attenuated live vaccine in last 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 |
|---|---|---|
| Quadrivalent influenza vaccineSubjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain. | Biological | Quadrivalent influenza vaccine |
Primary outcome
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40%
Time frame: day 28 after dose 2
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Number of participants with Adverse Reactions (ARs)
Time frame: 28 days after each vaccination
Frequency and severity of ARs for 28 days after each vaccination
4 secondary outcomes
the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%
Time frame: day 28 after dose 2
Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5
Time frame: day 28 after dose 2
Number of participants with Adverse Events (AEs)
Time frame: 28 days after each vaccination
Number of participants with Serious Adverse Events (SAE)
Time frame: 6 months after the last 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 17 Aug 2022.
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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?
A Phase 4 study testing Quadrivalent influenza vaccine in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention 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 6 inclusion and 14 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 17 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?
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40% (time frame: day 28 after dose 2). 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 17 Aug 2022.