A Clinical Trial of an Quadrivalent Influenza Virus Subunit Vaccine in Chinese Children Aged 6 to 35 Months

NCT05645900 | Completed Phase 3

• 1 other identifier: 2017L04970/1-3
• Study Type: interventional
• Target: 2,772
• Locations: 1 country
• Sites: 1

Brief Summary

A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months. A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart. Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered. Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection. Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.

Conditions

Influenza

Outcome Measures

Primary Outcomes (5)

• Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation

  Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation

  Within 30 minutes after each dose

• Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation

  Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation

  Within 0-7 days after each dose

• Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation

  Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation

  Within 8-28/30 days after each dose

• Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination

  Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination

  Within 6 months from the first dose to the full course of vaccination

• The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization

  The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization

  At 28 days after full immunization

Secondary Outcomes (2)

• The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization

  At 3 months after full immunization

• The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization

  At 6 months after full immunization

Study Arms (3)

experimental vaccine 1

EXPERIMENTAL

Subjects received 2 doses of 0.5 mL of quadrivalent influenza virus subunit vaccine, 28 days apart

Biological: Quadrivalent influenza virus subunit vaccine

experimental vaccine 2

EXPERIMENTAL

Subjects received 2 doses of 0.25 mL of quadrivalent influenza virus subunit vaccine, 28 days apart

Biological: Quadrivalent influenza virus subunit vaccine

control vaccine

ACTIVE COMPARATOR

Subjects received 2 doses of 0.25 mL of Quadrivalent split influenza virus vaccine, 28 days apart

Biological: Quadrivalent split influenza virus vaccine

Interventions

Quadrivalent influenza virus subunit vaccine BIOLOGICAL

This vaccine（0.5ml） is produced by Ab\&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection

experimental vaccine 1

Quadrivalent split influenza virus vaccine BIOLOGICAL

This vaccine（0.25ml） is produced by HUALAN BIO。Subjects will receive two doses of quadrivalent split influenza virus vaccine administered 28 days apart by intramuscular injection

control vaccine

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months healthy infants;
• The legal guardian voluntarily consented to the subject's participation in the study, and the legal guardian/trustee signed the Informed Consent Form and complied with the requirements of the protocol.

You may not qualify if:

• Armpit temperature ≥37.3℃ on the day of enrollment;
• Persons infected with influenza virus confirmed by laboratory testing within the previous 6 months;
• Received any influenza vaccine (registered or experimental) within the previous 12 months or planned to receive any influenza vaccine during the study period;
• Allergic to any components of the vaccine, such as eggs, excipients, formaldehyde, etc;
• Previous history of severe allergy to any vaccine or drug (e.g., but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction);
• months: premature (delivered before the 37th week of gestation), low weight (birth weight \<2500g) , or a history of dystocia, asphyxia rescue, and neurological damage;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
• Acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination;
• Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;
• History of asthma, instability within the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids;
• Progressive neurological disease, history of seizures, epilepsy, encephalopathy, Guillain-Barre syndrome, or history or family history of mental illness;
• Suffering from serious cardiovascular disease (heart disease, pulmonary heart disease, pulmonary edema);
• Asplenia, functional asplenia, and asplenia or splenectomy resulting from any condition; Resection or partial resection of other important organs;
• History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease);
• A history of live attenuated vaccine vaccination within 14 days and a history of other vaccines within 7 days before vaccination;

Sponsors & Collaborators

• Henan Center for Disease Control and Prevention: collaborator
• Ab&B Bio-tech Co., Ltd.JS: lead

Study Sites (1)

Ab&b Biotechnology Co., Ltd.JS

Taizhou, Jiangsu, 225300, 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 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: December 2, 2022
• First Posted: December 12, 2022
• Study Start: February 6, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)