Prevention of InfluenzaPhase 3NCT05642078
Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine
A Phase 3 study testing Investigational Vaccine(0.25ml/vial), Investigational Vaccine(0.5ml/vial) and Active compared Vaccine in people with Prevention of Influenza, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Influenza
- What is being tested?
- Investigational Vaccine(0.25ml/vial), Investigational Vaccine(0.5ml/vial) and Active compared Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,550 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2023to 5 Jan 2024
- 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
- （1）The age at the time of joining the group is 6-35 months old, and can provide legal identification.
- （2）The legal guardian of the subject voluntarily agreed to the child's participation in the study and signed the informed consent form.
- （3）The legal guardian of the subject has the ability to understand the research procedures and to participate in the follow-up of all plans.
- （4）On the day of joining the group, the armpit temperature was less than 37.3 ℃.
Who cannot join
- （1）Before joining the group, they have been vaccinated against influenza in this epidemic season or have plans to receive influenza vaccination during the study period.
- （2）Suffered from influenza disease in the past 3 months (confirmed by clinical, serological or microbiological methods)
- （3）Babies (6-11 months old) are born with a gestational age of < 37 weeks or ≥ 42 weeks.
- （4）Babies (6-11 months old) weigh less than 2.5kg or > 4.0kg at birth and are not suitable to participate in this study.
- （5）Babies (6-11 months old) are born during abnormal labor (dystocia, instrumental delivery, excluding caesarean section) or have a history of asphyxia or neurological damage
- （6）Previous history of severe allergy to any vaccine / drug or to any component of the test vaccine (including ovalbumin, etc.), such as anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction), severe urticaria, etc.
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- （7）Have a history of severe allergy to eggs or egg proteins, such as angioneurotic edema, dyspnea, chest tightness, or repeated vomiting due to eating eggs, or even use epinephrine or other emergency medical treatment, especially those who develop symptoms within a short period of time (minutes to hours) after eating.
- （8）Acute disease or acute attack of chronic disease occurred within 3 days before vaccination.
- （9）Before entering the group, the interval between other live vaccines was less than 7 days, and the interval between live attenuated vaccines was less than 14 days.
- （10）Use antipyretic analgesic or antiallergic drugs within 3 days before entering the group.
- （11）Have used other research or unregistered products (drugs or vaccines) within 1 month before joining the group, or plan to participate in other clinical studies after joining the group.
- （12）Long-term use of immunosuppressants or other immunomodulatory drugs within the first 3 months (defined as continuous use for more than 14 days), such as glucocorticoid dose ≥ 0.5mg/kg/ days (inhaled and topical glucocorticoids are not restricted)
- （13）Received blood or blood-related products within 6 months before joining the group (hepatitis B immunoglobulin acceptable).
- （14）Has been diagnosed with congenital or acquired immunodeficiency disease.
- （15）Suffering from serious diseases or congenital malformations that may interfere with the conduct or completion of research (including, but not limited to, respiratory diseases such as asthma or chronic bronchitis, Down syndrome, thalassemia, heart disease, nephropathy, autoimmune diseases, Guillain-Barre syndrome, severe developmental disorders, severe eczema, etc.)
- （16）Has been diagnosed with systemic diseases that may interfere with the conduct or completion of research, such as tuberculosis, viral hepatitis and / or human immunodeficiency virus HIV infection.
- （17）Have a history of convulsions, epilepsy, encephalopathy and mental illness or family history.
- （18）There are contraindications for intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment.
- （19）No spleen, functional no spleen, and no spleen or splenectomy caused by any condition.
- （20）Plan to move out of Hong Kong before the end of the study or for a long period of time during the visit to the project study.
- （21）The researchers believe that the subjects have any situation that may interfere with the evaluation of the purpose of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
Official title: A Randomized, Blind, Position-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Quadrivalent Influenza Virus Split Vaccine in 6-35 Months of Age
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
Read the detailed description
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
Immunogenicity observation Venous blood (2.5-3.0ml) was collected from all subjects before the first dose and 30 days after the full dose, and serum was separated for detection of Hemagglutination Inhibition antibodies against four influenza virus serotypes (H1N1, H3N2, B (V), B (Y)).
Safety observation All AE within 30 minutes of each dose, solicited adverse events at 0-7 days, non-solicited adverse events at 0-28 days (first dose) /30 days (second dose), and all serious adverse events from the first dose to 6 months after the full dose were collected.
- Conditions
- Prevention of Influenza
- Being tested
- Investigational Vaccine(0.25ml/vial), Investigational Vaccine(0.5ml/vial), Active compared Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Vaccine(0.25ml/vial)Biological
Subjects were vaccinated with a dose of low-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
Investigational Vaccine(0.5ml/vial)Biological
Subjects were vaccinated with a dose of high-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
Active compared VaccineBiological
Subjects were vaccinated with a dose of active compared vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Vaccine(Low dose group) | Experimental | Quadrivalent influenza vaccine(Split Virion),Inactivated，Produced by Anhui Zhifei Longcom Biopharmceutical Co., Ltd.；0.25mL/branch, each contains 7.5 μg H1N1, H3N2, B(V), B(Y) hemagglutinin.Subjects were vaccinated with one dose of vaccine on day 0 and day 28 respectively. Receives: Biological: Investigational Vaccine(0.25ml/vial) |
| Investigational Vaccine(High dose group) | Experimental | Quadrivalent influenza vaccine(Split Virion),Inactivated，Produced by Anhui Zhifei Longcom Biopharmceutical Co., Ltd.；0.5mL/branch, each contains 15 μg H1N1, H3N2, B(V), B(Y) hemagglutinin.Subjects were vaccinated with one dose of vaccine on day 0 and day 28 respectively. Receives: Biological: Investigational Vaccine(0.5ml/vial) |
| Active compared Vaccine | Active comparator | Influenza Vaccine(Split Virion),Inactivated Quadrivalent,Produced by Hualan Biological Vaccine Co., Ltd.;0.25mL/branch,each contains 7.5 μg H1N1, H3N2, B(V), B(Y) hemagglutinin.Subjects were vaccinated with one dose of vaccine on day 0 and day 28 respectively. Receives: Biological: Active compared Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity end point 1
30 days after the whole vaccination, the seroconversion rate of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Measured: 30 days after the whole vaccination
Immunogenicity end point 2
30 days after the whole vaccination, the geometric mean titer of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Measured: 30 days after the whole vaccination
Immunogenicity end point 3
30 days after the whole vaccination, the seroprotection rate of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Measured: 30 days after the whole vaccination
Immunogenicity end point 4
30 days after the whole vaccination, the geometric mean increase of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Measured: 30 days after the whole vaccination
Safety end point 1
Incidence and severity distribution of all adverse events within 30 days from the first dose to the whole course of vaccination.
Measured: Within 30 days from the first dose to the whole course of vaccination
Safety end point 2
Incidence and severity distribution of total AE within 30 minutes after each dose.
Measured: Within 30 minutes after each dose
Safety end point 3
Incidence and severity distribution of conscriptive adverse events within 7 days after each dose.
Measured: Within 7 days after each dose
Safety end point 4
Incidence and severity distribution of non-aggregative adverse events within 0-28 days after first dose vaccination and 0-30 days after second dose vaccination.
Measured: Within 0-28 days after first dose vaccination and 0-30 days after second dose vaccination
Safety end point 5
Incidence of serious adverse events within 6 months from the first dose to the whole course of vaccination.
Measured: Within 6 months from the first dose to the whole course of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start18 Feb 2023
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Huang, Bachelor, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642078
- Sponsor's protocol ID
- LKM-2022-FIn001
- Status last verified
- Oct 2023
- First submitted
- 25 Nov 2022
- Last updated
- 10 Jan 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Position-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Quadrivalent Influenza Virus Split Vaccine in 6-35 Months of Age
- ClinicalTrials.gov ID
- NCT05642078
- Acronym / sponsor ID
- LKM-2022-FIn001
- Conditions
- Prevention of Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,550 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 8 Dec 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.
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
Detailed description
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
Immunogenicity observation Venous blood (2.5-3.0ml) was collected from all subjects before the first dose and 30 days after the full dose, and serum was separated for detection of Hemagglutination Inhibition antibodies against four influenza virus serotypes (H1N1, H3N2, B (V), B (Y)).
Safety observation All AE within 30 minutes of each dose, solicited adverse events at 0-7 days, non-solicited adverse events at 0-28 days (first dose) /30 days (second dose), and all serious adverse events from the first dose to 6 months after the full dose were collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Vaccine(Low dose group) | Experimental | Biological: Investigational Vaccine(0.25ml/vial)Quadrivalent influenza vaccine(Split Virion),Inactivated，Produced by Anhui Zhifei Longcom Biopharmceutical Co., Ltd.；0.25mL/branch, each contains 7.5 μg H1N1, H3N2, B(V), B(Y) hemagglutinin.Subjects were vaccinated with one dose of vaccine on day 0 and day 28 respectively. |
| Investigational Vaccine(High dose group) | Experimental | Biological: Investigational Vaccine(0.5ml/vial)Quadrivalent influenza vaccine(Split Virion),Inactivated，Produced by Anhui Zhifei Longcom Biopharmceutical Co., Ltd.；0.5mL/branch, each contains 15 μg H1N1, H3N2, B(V), B(Y) hemagglutinin.Subjects were vaccinated with one dose of vaccine on day 0 and day 28 respectively. |
| Active compared Vaccine | Active comparator | Biological: Active compared VaccineInfluenza Vaccine(Split Virion),Inactivated Quadrivalent,Produced by Hualan Biological Vaccine Co., Ltd.;0.25mL/branch,each contains 7.5 μg H1N1, H3N2, B(V), B(Y) hemagglutinin.Subjects were vaccinated with one dose of vaccine on day 0 and day 28 respectively. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- （1）The age at the time of joining the group is 6-35 months old, and can provide legal identification.
- （2）The legal guardian of the subject voluntarily agreed to the child's participation in the study and signed the informed consent form.
- （3）The legal guardian of the subject has the ability to understand the research procedures and to participate in the follow-up of all plans.
- （4）On the day of joining the group, the armpit temperature was less than 37.3 ℃.
Key exclusion criteria (21 listed)
- （1）Before joining the group, they have been vaccinated against influenza in this epidemic season or have plans to receive influenza vaccination during the study period.
- （2）Suffered from influenza disease in the past 3 months (confirmed by clinical, serological or microbiological methods)
- （3）Babies (6-11 months old) are born with a gestational age of < 37 weeks or ≥ 42 weeks.
- （4）Babies (6-11 months old) weigh less than 2.5kg or > 4.0kg at birth and are not suitable to participate in this study.
- （5）Babies (6-11 months old) are born during abnormal labor (dystocia, instrumental delivery, excluding caesarean section) or have a history of asphyxia or neurological damage
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 |
|---|---|---|
| Investigational Vaccine(0.25ml/vial)Subjects were vaccinated with a dose of low-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm. | Biological | Investigational Vaccine(Low dose group) |
| Investigational Vaccine(0.5ml/vial)Subjects were vaccinated with a dose of high-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm. | Biological | Investigational Vaccine(High dose group) |
| Active compared VaccineSubjects were vaccinated with a dose of active compared vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm. | Biological | Active compared Vaccine |
Primary outcome
Immunogenicity end point 1
Time frame: 30 days after the whole vaccination
30 days after the whole vaccination, the seroconversion rate of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Immunogenicity end point 2
Time frame: 30 days after the whole vaccination
30 days after the whole vaccination, the geometric mean titer of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Immunogenicity end point 3
Time frame: 30 days after the whole vaccination
30 days after the whole vaccination, the seroprotection rate of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Immunogenicity end point 4
Time frame: 30 days after the whole vaccination
30 days after the whole vaccination, the geometric mean increase of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Safety end point 1
Time frame: Within 30 days from the first dose to the whole course of vaccination
Incidence and severity distribution of all adverse events within 30 days from the first dose to the whole course of vaccination.
Safety end point 2
Time frame: Within 30 minutes after each dose
Incidence and severity distribution of total AE within 30 minutes after each dose.
Safety end point 3
Time frame: Within 7 days after each dose
Incidence and severity distribution of conscriptive adverse events within 7 days after each dose.
Safety end point 4
Time frame: Within 0-28 days after first dose vaccination and 0-30 days after second dose vaccination
Incidence and severity distribution of non-aggregative adverse events within 0-28 days after first dose vaccination and 0-30 days after second dose vaccination.
Safety end point 5
Time frame: Within 6 months from the first dose to the whole course of vaccination
Incidence of serious adverse events within 6 months from the first dose to the whole course of 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 10 Jan 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.
Tao Huang, Bachelor principal investigator
Hunan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational Vaccine(0.25ml/vial), Investigational Vaccine(0.5ml/vial) and Active compared Vaccine in people with Prevention of Influenza, run by Anhui Zhifei Longcom Biologic Pharmacy 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 21 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 10 Jan 2024. 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 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 end point 1 (time frame: 30 days after the whole vaccination). The study lists 9 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 10 Jan 2024.