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Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

NCT06622590 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-01-28

No results posted yet for this study

Summary

This is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization.

Conditions

  • Influenza, Human
  • Influenza a
  • Influenza Type B
  • Influenza Viral Infections

Interventions

BIOLOGICAL

QIV

Quadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose

BIOLOGICAL

QIV control

Quadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose

Sponsors & Collaborators

  • Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

    collaborator OTHER_GOV

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Teng Huang · Guangxi Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-13
Primary Completion
2025-01-09
Completion
2025-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622590 on ClinicalTrials.gov