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Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

NCT03859141 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2340

Last updated 2019-03-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

Conditions

Interventions

BIOLOGICAL

Quadrivalent influenza vaccine

One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

BIOLOGICAL

Quadrivalent influenza vaccine

One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

BIOLOGICAL

Trivalent influenza vaccine (contains B/Victoria strain)

One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.

BIOLOGICAL

Trivalent influenza vaccine (contains B/Yamagata strain)

One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yuemei Hu, Bachelor · Jiangsu Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2018-04-17
Completion
2018-11-02

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 NCT03859141 on ClinicalTrials.gov