Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

NCT06800950 | Not Yet Recruiting Phase 3

• 1 other identifier: 20221201_3
• Study Type: interventional
• Target: 4,400
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.

Conditions

Influenza, Human; Influenza, Human Prevention; Influenza a; Influenza B; Influenza Viral Infections

Outcome Measures

Primary Outcomes (6)

• Immunogenicity index - seroconversion rates of HI antibody against all types

  Antibody assay will be performed using the hemagglutination inhibition test. Seroconversion will be defined as a change from seronegative (Antibody titers\<1:40) to seropositive (Antibody titers≥1:40), or a ≥4-fold increase from baseline.

  Between baseline and Day 30 after full vaccination

• Immunogenicity index - Seropositive rates of HI antibody against all types

  Antibody assay will be performed using the hemagglutination inhibition test. Seropositive is defined as antibody titers≥1:40

  Day 30 after full vaccination

• Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types

  Antibody assay will be performed using the hemagglutination inhibition test.

  Day 30 after full vaccination

• Safety index - incidence of adverse events/adverse reactions

  Incidence of adverse events/adverse reactions after the first dose vaccination

  Day 0 to 7 after the first dose vaccination

• Safety index - incidence of adverse events/adverse reactions

  Incidence of adverse events/adverse reactions after the second dose vaccination (applicable for the two-dose children cohort)

  Day 0 to 7 after the second dose vaccination

• Safety index - incidence of adverse events/adverse reactions

  Incidence of adverse events/adverse reactions after full vaccination

  From Day 0 to Day 30 after full vaccination

Secondary Outcomes (4)

• Safety index - incidence of serious adverse events/adverse reactions

  From the beginning of the vaccination up to 6 months after the last vaccination completed

• Immunogenicity index - seroconversion rates of HI antibody against all types

  Between baseline and Day 30 after full vaccination

• Immunogenicity index - Seropositive rates of HI antibody against all types

  Day 30 after full vaccination

• Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types

  Day 30 after full vaccination

Study Arms (7)

Intervention (Aged 9-59 years, one-dose)

EXPERIMENTAL

QIV in adults and adolescents aged 9-59 years on Day 0

Biological: QIV

Control (Aged 9-59 years, one-dose)

ACTIVE COMPARATOR

Control Vaccine in adults and adolescents aged 9-59 years on Day 0

Biological: QIV Control

Intervention (Elders aged 60 years and above, one-dose)

EXPERIMENTAL

QIV in elders aged 60 years and above on Day 0

Biological: QIV

Control (Elders aged 60 years and above, one-dose)

ACTIVE COMPARATOR

Control vaccine in elders aged 60 years and above on Day 0

Biological: QIV Control

Intervention (Children aged 3-8 years, two-dose)

EXPERIMENTAL

QIV in children aged 3-8 years on Day 0 and Day 28

Biological: QIV

Intervention (Children aged 3-8 years, one-dose)

EXPERIMENTAL

QIV in children aged 3-8 years on Day 0

Biological: QIV

Control (Children aged 3-8 years, one-dose)

ACTIVE COMPARATOR

Control vaccine n children aged 3-8 years on Day 0

Biological: QIV Control

Interventions

QIV BIOLOGICAL

Quadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose

Intervention (Aged 9-59 years, one-dose); Intervention (Children aged 3-8 years, one-dose); Intervention (Children aged 3-8 years, two-dose); Intervention (Elders aged 60 years and above, one-dose)

QIV Control BIOLOGICAL

Quadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose

Control (Aged 9-59 years, one-dose); Control (Children aged 3-8 years, one-dose); Control (Elders aged 60 years and above, one-dose)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age Requirement: volunteers aged 3 years and above at the time of enrollment.
• Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
• Informed Consent: Volutters, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
• Requirements for contraception: agree to take contraception actions in 6 months.
• Temperature Requirement: Axillary body temperature is less than 37.3°C.
• Previous Vaccination Requirements: (a) Received at least 1 dose of influenza vaccine within 1 year before screening in children aged 3-8 years; (b) Never received any influenza vaccine 1 year before screening in children aged over 3 years.

You may not qualify if:

• Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).
• Subjects with influenza illness (clinically, serologically, or microbiologically confirmed) within 6 months before screening and enrollment.
• Have received an influenza vaccine within 1 year before enrollment or scheduled to receive another influenza vaccine during the study period.
• Allergic to any component contained in the investigational vaccine, or previous history of severe allergic to any vaccine or drug, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria, etc.
• History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment, or subjects have scheduled to receive another vaccine within 1 month after receipt of the investigational vaccine
• Subjects with convulsion, epilepsy, encephalopathy (such as moderate to severe hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumor, cerebral infarction, stroke, intracranial infection, etc.), psychiatric history or family history
• Have been diagnosed with a serious medical condition or congenital malformation that may interfere with the conduct or completion of the study (including but not limited to suffering from respiratory diseases such as asthma or during episodes of chronic bronchitis, Down syndrome, thalassemia, heart disease, severe cardiac arrhythmias, kidney disease, diabetes (diabetics with poor glycemic control or severe complications), autoimmune diseases, genetic allergies, Guillain-Barre syndrome, Crohn disease, malignancies, severe infectious/allergic skin diseases, etc.)
• Adults aged 18 years or older with medically uncontrolled abnormal blood pressure (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg or systolic blood pressure ≤ 90mmHg and/or diastolic blood pressure ≤ 60 mmHg)
• Subjects with acute illness or in the acute phase of a chronic illness within 3 days before vaccination
• Subjects with fever (axillary temperature ≥37.3 ° C) within 3 days before vaccination or use of antipyretic, analgesic, or antiallergic medications
• Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders
• Have received a blood transfusion or use of blood products within 3 months before enrollment, or planned to do so within 1 month after full immunization
• History of surgical removal of the spleen or other vital organs for any reason
• Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study
• Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control: collaborator

Study Sites (3)

Xing'an Center for Disease Control and Prevention

Guilin, Guangxi, China

Location

Yangshuo Center for Disease Control and Prevention

Guilin, Guangxi, China

Location

Binyang Center for Disease Control and Prevention

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Teng Huang

  Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoyang Liao

CONTACT

0871-68334483; liaogy@imbcams.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: February 8, 2025
• Primary Completion: July 15, 2025
• Study Completion: October 15, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)