NCT05645900

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

Immunogenicity and Safety of a Quadrivalent Influenza Virus Subunit Vaccine in Subjects Aged 6-35 Months : A Randomized, Double-blind, Active-controlled Phase III Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,772 (actual)
• Sponsor: Ab&B Bio-tech Co., Ltd.JS · Academic / Other
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent influenza virus subunit vaccine	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
BIOLOGICAL	Quadrivalent influenza virus subunit vaccine	This vaccine（0.25ml） 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
BIOLOGICAL	Quadrivalent split influenza virus vaccine	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

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2022-12-12
• Last updated: 2026-01-02

Locations

1 site across 1 country: China