InfluenzaPhase 1NCT05212623
A Clinical Trial of an Quadrivalent Inactivated Influenza Vaccine in Healthy Children Aged 6 to 35 Months
A Phase 1 study testing quadrivalent influenza split vaccine and Influenza virus split vaccine in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
In this single-center, randomized, blinded, positive-controlled design, the investigators will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza vaccine in children aged 6 to 35 months. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- quadrivalent influenza split vaccine and 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2021to 16 Jun 2022
- Phase
- Phase 1
- 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 and young children aged 6-35 months, provide vaccination certificate and birth medical certificate.
- The subject or legal guardian can provide with informed consent and sign the informed consent form.
- The subjects or legal guardians are able to and willing to use a thermometer, a scale and fill in a diary card/contact card as required, and be able to comply with the requirements of the clinical trial protocol to complete clinical research.
Who cannot join
- st dose:
- Axillary temperature>37.0℃
- Participants aged 24-35 months, with abnormal blood routine, blood biochemical and urine routine indexes and judged by the researchers as having clinical significance.
- Influenza within the past 3 months (confirmed clinically, serologically or microbiological).
- Have previously received any influenza vaccine (registered or experimental) or planned to receive any influenza vaccine during the study.
- Allergy to any component of the study vaccine, history of allergic reaction to eating eggs or using gentamicin sulfate.
Show all 27Show fewer
- History of severe allergies to any vaccines or drugs.
- Preterm (delivered before 37 weeks of gestation), low birth weight (birth weight <2500g) infants (only for volunteers aged 6 months to 12 months).
- Dystocia, suffocation rescue, nervous system damage history.
- Congenital malformations or developmental disorders affecting organ function, genetic defects, severe malnutrition, etc..
- Acute illness, severe chronic illness, or acute exacerbation of chronic illness on the day of vaccination.
- History of vaccination with the live attenuated vaccine within 14 days prior to vaccination and other vaccination within 7 days.
- Those receiving immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
- Have congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
- History of asthma, unstable in the past two years requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids.
- Receive blood or blood-related products within 3 months.
- Have a medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- History of coagulation abnormalities (eg, coagulation factor deficiency, coagulation disorder)
- Plan to relocate before the end of the study or to be away from home for an extended period of time during scheduled study visits
- Participating in or planning to participate in other clinical trials in the near future
- Abnormal laboratory test indicators, except for minor abnormalities that have no clinical significance as judged by the doctor.
- The investigator judges any situation that is inappropriate to participate in this clinical trial
- nd dose:
- Severe allergic reaction after the first dose of the vaccine.
- Serious adverse reactions causally related to the first dose of the vaccine.
- After the first vaccination, newly discovered or newly occurred do not meet the first-dose inclusion criteria or meet the first-dose exclusion criteria will be determined by the investigator whether to continue participating in the study.
- Other reasons for exclusion in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Single-center, Randomized, Blinded, Positive Controlled Clinical Trial to Assess the Reactogenicity and Immunogenicity of a Quadrivalent Inactivated Influenza Vaccine in Healthy Participants Aged 6-35 Months
In this single-center, randomized, blinded, positive-controlled design, the investigators will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza vaccine in children aged 6 to 35 months.
About 120 healthy participants are planned to be enrolled, of who 60 participants were enrolled in the low-dose group and 60 participants were enrolled in the high-dose group. In the low-dose group, participants were randomly (2:1:1) assigned to receive a quadrivalent inactivated influenza vaccine (IIV4) at 0.25 mL including A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, and a trivalent inactivated influenza vaccine (IIV3) at 0.25 mL including A/H1N1, A/H3N2 and B/Victoria, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. In the high-dose group, participants were randomly (2:1:1) assigned to receive IIV4 at 0.5 mL, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Victoria, and IV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. Subjects receive 2 doses of influenza vaccine 4 weeks apart.
The occurrence of adverse reactions within 30 minutes, the occurrence of adverse reactions within 28 days, and serious adverse events within 6 months after vaccination will be observed in all participants. For participants aged 24-35 months in each dose group, laboratory safety tests were measured before enrollment and on day 4 post each dose to assess any toxic effects. In addition, all subjects will be required to collect blood for HI antibody testing before the first dose of vaccination and 30 days after the second dose of vaccination.
- Conditions
- Influenza
- Being tested
- quadrivalent influenza split vaccine, Influenza virus split vaccine
- Keywords
- Influenza, quadrivalent influenza split vaccine, reactogenicity, 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 split vaccineBiological
This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection
quadrivalent influenza split vaccineBiological
This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection
Influenza virus split vaccineBiological
This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection
Influenza virus split vaccineBiological
This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects received 2 doses of 0.25 mL of quadrivalent influenza vaccine, 4 weeks apart.
Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata). Receives: Biological: quadrivalent influenza split vaccine |
| Group B | Experimental | Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.(Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata). Receives: Biological: quadrivalent influenza split vaccine |
| Group C | Active comparator | Subjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 type of virus strains, including BY). Receives: Biological: Influenza virus split vaccine |
| Group D | Active comparator | Subjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 types of virus strains, including BV). Receives: Biological: Influenza virus split vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)
Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)
Measured: On day 7 after each dose
Secondary outcomes (6)
Incidence of adverse events from the first dose to 30 days after the second dose in the participants aged 6-35 months.
Incidence of adverse events from the first dose to 30 days after the second dose in the participants aged 6-35 months.
Measured: Time Frame: within 30 days after the second dose
Incidence of serious adverse events (SAE) till the 6 months after the second dose in the participants aged 6-35 months.
Incidence of serious adverse events (SAE) till the 6 months after the second dose in the participants aged 6-35 months.
Measured: within 6 months after the second dose
HI antibody-positive conversion rate in each group 30 days after the second vaccination in the participants aged 6-35 months.
HI antibody-positive conversion rate in each group 30 days after the second vaccination in the participants aged 6-35 months.
Measured: on day 30 after the second vaccination
Seroprotection rate 30 days after the second dose in each group in the participants aged 6-35 months.
Seroprotection rate 30 days after the second dose in each group in the participants aged 6-35 months.
Measured: on day 30 after the second vaccination
GMT of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
GMT of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
Measured: on day 30 after the second vaccination
GMI of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
GMI of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
Measured: on day 30 after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start26 Oct 2021
- Primary completion17 Jan 2022
- Study completion16 Jun 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Changchun Institute of Biological Products Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212623
- Sponsor's protocol ID
- LGYM（SJ）-2021-I
- Status last verified
- Mar 2022
- First submitted
- 16 Jan 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Blinded, Positive Controlled Clinical Trial to Assess the Reactogenicity and Immunogenicity of a Quadrivalent Inactivated Influenza Vaccine in Healthy Participants Aged 6-35 Months
- ClinicalTrials.gov ID
- NCT05212623
- Acronym / sponsor ID
- LGYM（SJ）-2021-I
- Conditions
- Influenza
- Keywords
- Influenza, quadrivalent influenza split vaccine, reactogenicity, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Changchun Institute of Biological Products Co., Ltd.
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 28 Jan 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.
In this single-center, randomized, blinded, positive-controlled design, the investigators will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza vaccine in children aged 6 to 35 months.
About 120 healthy participants are planned to be enrolled, of who 60 participants were enrolled in the low-dose group and 60 participants were enrolled in the high-dose group. In the low-dose group, participants were randomly (2:1:1) assigned to receive a quadrivalent inactivated influenza vaccine (IIV4) at 0.25 mL including A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, and a trivalent inactivated influenza vaccine (IIV3) at 0.25 mL including A/H1N1, A/H3N2 and B/Victoria, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. In the high-dose group, participants were randomly (2:1:1) assigned to receive IIV4 at 0.5 mL, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Victoria, and IV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. Subjects receive 2 doses of influenza vaccine 4 weeks apart.
The occurrence of adverse reactions within 30 minutes, the occurrence of adverse reactions within 28 days, and serious adverse events within 6 months after vaccination will be observed in all participants. For participants aged 24-35 months in each dose group, laboratory safety tests were measured before enrollment and on day 4 post each dose to assess any toxic effects. In addition, all subjects will be required to collect blood for HI antibody testing before the first dose of vaccination and 30 days after the second dose of vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: quadrivalent influenza split vaccineSubjects received 2 doses of 0.25 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata). |
| Group B | Experimental | Biological: quadrivalent influenza split vaccineSubjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.(Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata). |
| Group C | Active comparator | Biological: Influenza virus split vaccineSubjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 type of virus strains, including BY). |
| Group D | Active comparator | Biological: Influenza virus split vaccineSubjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 types of virus strains, including BV). |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants and young children aged 6-35 months, provide vaccination certificate and birth medical certificate.
- The subject or legal guardian can provide with informed consent and sign the informed consent form.
- The subjects or legal guardians are able to and willing to use a thermometer, a scale and fill in a diary card/contact card as required, and be able to comply with the requirements of the clinical trial protocol to complete clinical research.
Key exclusion criteria (27 listed)
- st dose:
- nd dose:
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 split vaccineThis vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection | Biological | Group A |
| quadrivalent influenza split vaccineThis vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection | Biological | Group B |
| Influenza virus split vaccineThis vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection | Biological | Group C |
| Influenza virus split vaccineThis vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection. | Biological | Group D |
Primary outcome
Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)
Time frame: On day 7 after each dose
Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)
6 secondary outcomes
Incidence of adverse events from the first dose to 30 days after the second dose in the participants aged 6-35 months.
Time frame: Time Frame: within 30 days after the second dose
Incidence of serious adverse events (SAE) till the 6 months after the second dose in the participants aged 6-35 months.
Time frame: within 6 months after the second dose
HI antibody-positive conversion rate in each group 30 days after the second vaccination in the participants aged 6-35 months.
Time frame: on day 30 after the second vaccination
Seroprotection rate 30 days after the second dose in each group in the participants aged 6-35 months.
Time frame: on day 30 after the second vaccination
GMT of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
Time frame: on day 30 after the second vaccination
GMI of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.
Time frame: on day 30 after the second 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 Oct 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 1 study testing quadrivalent influenza split vaccine and Influenza virus split 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 3 inclusion and 27 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 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance) (time frame: On day 7 after each dose). 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 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.