[Translation] A single-center, randomized, open-label, non-inferiority trial was designed to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide conjugate vaccine and adsorbed acellular diphtheria, tetanus and pertussis combined vaccine administered simultaneously or at intervals.

评价13价肺炎球菌多糖结合疫苗在3月龄健康婴儿中和免疫规划吸附无细胞百白破联合疫苗同时接种或间隔接种的免疫原性和安全性。

[Translation]

To evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide conjugate vaccine administered simultaneously or at intervals with adsorbed acellular diphtheria, tetanus and pertussis combined vaccine in immunization schedule in healthy infants aged 3 months.

Start Date14 May 2022

Sponsor / Collaborator

Yuxi Walvax Biotechnology Co., Ltd.

[+1]

CTR20190621 / CompletedPhase 4

观察上市后吸附无细胞百白破联合疫苗的安全性和免疫原性的IV期临床研究

[Translation] Phase IV clinical study to observe the safety and immunogenicity of post-marketing adsorbed acellular diphtheria, tetanus and pertussis combined vaccine

主要目的：观察上市后吸附无细胞百白破联合疫苗接种于3～12月龄婴儿和18～24月龄幼儿的安全性。探索性目的：观察上市后吸附无细胞百白破联合疫苗接种于3～12月龄婴儿和18～24月龄幼儿的免疫原性。

[Translation]

Primary objective: To observe the safety of post-marketing adsorbed acellular diphtheria, tetanus and pertussis combined vaccine in infants aged 3 to 12 months and children aged 18 to 24 months. Exploratory objective: To observe the immunogenicity of post-marketing adsorbed acellular diphtheria, tetanus and pertussis combined vaccine in infants aged 3 to 12 months and children aged 18 to 24 months.

Start Date08 Apr 2019

Sponsor / Collaborator

Yuxi Walvax Biotechnology Co., Ltd.

100 Clinical Results associated with Diphtheria,tetanus and acellular pertussis combined Vaccine,adsorbed(Yuxi Walvax Biotechnology Co., Ltd.)

100 Translational Medicine associated with Diphtheria,tetanus and acellular pertussis combined Vaccine,adsorbed(Yuxi Walvax Biotechnology Co., Ltd.)

100 Patents (Medical) associated with Diphtheria,tetanus and acellular pertussis combined Vaccine,adsorbed(Yuxi Walvax Biotechnology Co., Ltd.)

100 Deals associated with Diphtheria,tetanus and acellular pertussis combined Vaccine,adsorbed(Yuxi Walvax Biotechnology Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07AJ52	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	CN	Yuxi Walvax Biotechnology Co., Ltd.	27 Jul 2015
Tetanus	CN	Yuxi Walvax Biotechnology Co., Ltd.	27 Jul 2015
Whooping Cough	CN	Yuxi Walvax Biotechnology Co., Ltd.	27 Jul 2015

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