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

2019-03-07 02:51:19 | BioPortfolio

Summary

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

Description

The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.

Study Design

Conditions

Seasonal Influenza

Intervention

Quadrivalent influenza vaccine, Quadrivalent influenza vaccine, Trivalent influenza vaccine (contains B/Victoria strain), Trivalent influenza vaccine (contains B/Yamagata strain)

Location

Guanyun Center for Disease Prevention and Control
Lianyungang
Jiangsu
China
222200

Status

Completed

Source

Sinovac Biotech Co., Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-03-07T02:51:19-0500

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