Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China

NCT07710586 | Completed Phase 4

• 1 other identifier: CTR20244333
• Study Type: interventional
• Target: 3,105
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the safety of the quadrivalent subunit influenza vaccine in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence \<0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.

Conditions

Influenza Vaccine

Keywords

safety; Quadrivalent Subunit Influenza Vaccine

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AEs)

  Occurrence of adverse events (AEs) within 30 minutes, 7 days, and 28 days after vaccination

  30 minutes, 7 days, and 28 days after vaccination

• Adverse Drug Reactions（ADR）

  Incidence of known adverse drug reactions (ADRs) within 30 minutes, 7 days, and 28 days after vaccination

  30 minutes, 7 days, and 28 days after vaccination

• Serious Adverse Events (SAEs)

  Occurrence of serious adverse events (SAEs) within 6 months after vaccination; Incidence of new adverse reactions following vaccination； Incidence of cerebral infarction following vaccination； Incidence of systemic adverse reactions following vaccination in individuals aged 9 to 17 years

  6 months after vaccination

Study Arms (1)

The quadrivalent influenza subunit vaccine Group

EXPERIMENTAL

receive a single 0.5 mL intramuscular dose of the quadrivalent influenza subunit vaccine

Biological: quadrivalent subunit influenza vaccine

Interventions

quadrivalent subunit influenza vaccine BIOLOGICAL

one dose of quadrivalent subunit influenza vaccine

The quadrivalent influenza subunit vaccine Group

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:

• Healthy individuals aged 3 years or above.
• The participant (and/or their guardian/legal representative) has provided informed consent, voluntarily agreed to participate, signed the Informed Consent Form, and is able to comply with the requirements of this study protocol.

You may not qualify if:

• Individuals with a known allergy to any component of the vaccine, including eggs, excipients, formaldehyde, or Triton N-101.
• Individuals suffering from an acute illness, severe chronic disease, an acute exacerbation of a chronic disease, common cold, or fever.
• Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barré syndrome.
• Any other condition considered by the investigator as inappropriate for participation in this study.

Sponsors & Collaborators

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

Study Sites (2)

Dongtai Center for Disease Control and Prevention

Dongtai, Jiangsu, 224200, China

Location

Lianshui County Center for Disease Control and Prevention

Lianshui, Jiangsu, 223400, 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 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: November 15, 2024
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CN (2)