Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine

NCT ID: NCT05642078

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-18
• Study Completion Date: 2024-01-05

Brief 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. 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.

Conditions

Prevention of Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational Vaccine(Low dose group)

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.

Group Type: EXPERIMENTAL

Investigational Vaccine(0.25ml/vial)

Intervention Type: 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(High dose group)

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.

Group Type: EXPERIMENTAL

Investigational Vaccine(0.5ml/vial)

Intervention Type: 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 Vaccine

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.

Group Type: ACTIVE_COMPARATOR

Active compared Vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Active compared Vaccine

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• （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 ℃.

Exclusion Criteria

• （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.
• （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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Huang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Hunan Provincial Center for Disease Control and Prevention

Locations

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, China

Countries

China

Other Identifiers

LKM-2022-FIn001

Identifier Type: -

Identifier Source: org_study_id