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To Identify the Immunogenicity and Safety of QIV in Children Aged 3-8 Years

NCT05389137 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-05-25

No results posted yet for this study

Summary

To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study.

Sample size and test grouping:

In this study, a total of 360 subjects were enrolled in a self-controlled trial design.

In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group.

All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.

Conditions

Interventions

BIOLOGICAL

Inavtivated Quadrivalent Influenza Virus Split Vaccine

Prevent influenza caused by H1N1, H3N2, B (V), B (Y) strain virus infection.

Sponsors & Collaborators

  • Wuhan Institute of Biological Products Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jikai Zhang · Guangdong province institute of biologicals and materia medica

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2022-05-31
Completion
2022-10-31

Countries

  • China

Study Locations

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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 NCT05389137 on ClinicalTrials.gov