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Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine

NCT05642078 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2550

Last updated 2024-01-10

No results posted yet for this study

Summary

A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.

Conditions

  • Prevention of Influenza

Interventions

BIOLOGICAL

Investigational Vaccine(0.25ml/vial)

Subjects were vaccinated with a dose of low-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.

BIOLOGICAL

Investigational Vaccine(0.5ml/vial)

Subjects were vaccinated with a dose of high-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.

BIOLOGICAL

Active compared Vaccine

Subjects were vaccinated with a dose of active compared vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tao Huang, Bachelor · Hunan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-18
Primary Completion
2024-01-05
Completion
2024-01-05

Countries

  • China

Study Locations

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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 NCT05642078 on ClinicalTrials.gov