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ACTIVE NOT RECRUITING
NCT07854392
PHASE4

A Study to Evaluate the Immune Responses of Subunit Influenza Vaccine in Healthy Adults

Sponsor: Ab&B Bio-tech Co., Ltd.JS

View on ClinicalTrials.gov

Summary

This is a prospective, open-label, parallel time-cohort study designed to characterize the humoral and cellular immune responses induced by a subunit influenza vaccine (manufactured by Ab\&B Bio-tech Co., Ltd.JS) in healthy adults within one month after vaccination. Eligible participants will receive a single intramuscular dose and will be assigned in parallel to one of two blood-sampling schedules to capture the kinetic profile of the immune response: Group A (pre-vaccination, Day 5, and Day 14 post-vaccination) and Group B (pre-vaccination, Day 7, and Day 21 post-vaccination). Hemagglutination inhibition (HI) antibody titers will be measured to assess humoral immunity, while circulating CD4⁺ and CD8⁺ T-cell levels will be analyzed to evaluate cellular immunity. The occurrence of adverse events(AEs) and serious adverse events(SAEs) within 28 days post-vaccination will be recorded.

Official title: A Phase IV, Prospective, Open-label, Parallel Time-cohort Study to Evaluate the Immune Responses and Safety ofSubunit Influenza Vaccine in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2026-10-10

Completion Date

2027-10-11

Last Updated

2026-10-16

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Group A

Participants will receive one dose of Subunit Influenza Vaccine

BIOLOGICAL

Group B

Participants will receive one dose of Subunit Influenza Vaccine

Locations (1)

Shangyu District Center for Disease Control and Prevention

Shaoxing, Zhejiang, China