Safety Study of Quadrivalent Subunit Influenza Vaccine in People Aged 3 Years and Older

NCT07332689 | Completed

• 1 other identifier: CDRZ20234001-2
• Study Type: observational
• Target: 42,881
• Locations: 1 country
• Sites: 8

Brief Summary

This study evaluates the safety of the quadrivalent subunit influenza vaccine following its post-marketing widespread use in individuals aged 3 years and older, aiming to assess the occurrence of very rare adverse reactions (with an incidence rate of \<0.01%).

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 28 days after vaccination; Incidence of new adverse reactions following vaccination

  28 days after vaccination

Study Arms (1)

One dose Vaccine in aged 3 years and older

Biological: quadrivalent subunit influenza vaccine

Interventions

quadrivalent subunit influenza vaccine BIOLOGICAL

one dose of quadrivalent subunit influenza vaccine

One dose Vaccine in aged 3 years and older

Eligibility Criteria

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

Study Population

Healthy individuals aged 3 years or above

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 Provincial Academy of Preventive Medicine: collaborator
• Shandong Province Centers for Disease Control and Prevention: collaborator
• Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention: collaborator
• Hubei Provincial Center for Disease Control and Prevention: collaborator
• Shanghai Municipal Center for Disease Control and Prevention: collaborator
• Gansu Provincial Center for Disease Control and Prevention: collaborator
• Guangdong Provincial Institute of Biological Products And Materia Medica: collaborator
• Qinghai Provincial Center for Disease Control and Prevention: collaborator

Study Sites (8)

Gansu Provincial Center for Disease Control and Prevention

Lanzhou, Gansu, 730000, China

Location

Guangdong Provincial Institute of Biological Products and Materia Medica

Guangzhou, Guangdong, 510440, China

Location

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, 430079, China

Location

Jiangsu Provincial Academy of Preventive Medicine

Nanjing, Jiangsu, 210009, China

Location

Qinghai Provincial Center for Disease Control and Prevention

Xining, Qinghai, 810007, China

Location

Shandong Center for Disease Control and Prevention

Jinan, Shandong, 250014, China

Location

Shanghai Municipal Center for Disease Control and Prevention

Shanghai, Shanghai Municipality, 200336, China

Location

Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

Ürümqi, Xinjiang Uygur Autonomous Region, 830002, 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: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: October 30, 2023
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

CN (8)