A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China

Author:

Chen Shaomin1,Ying Zhifang2,Liu Yan3,Li Yuan1,Yu Yebin4,Huang Meilian4,Huang Zhuhang1,Ou Zhiqiang1,Liao Yuyi1,Zhang Yong3,Liu Guixiu5,Zhao Weiwei6,Fu Rong6,Shou Qiong6,Zheng Minghuan5,Liao Xueyan5,Tu Yingmei7,Stek Jon7,Hartzel Jonathan8,Li Changgui9,Zhang Jikai10

Affiliation:

1. Biological Products Surveillance and Evaluation, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, China

2. Respiratory Virus Vaccine, National Institutes for Food and Drug Control, Beijing, China

3. Division of Hepatitis Virus and Enterovirus Vaccines, National Institutes for Food and Drug Control, Beijing, China

4. Vaccine Clinical Research Office, Yangchun Center for Disease Control and Prevention, Yangchun, Guangdong, China

5. Clinical Research, MSD Research and Development (China) Co. Ltd., Beijing, China

6. Biostatistics and Research Decision Sciences, MSD Research and Development (China) Co. Ltd., Beijing, China

7. Infectious Diseases/Vaccines Clinical Research, Merck & Co. Inc., Rahway, NJ, USA

8. Biostatistics and Research Decision Sciences, Merck & Co. Inc., Rahway, NJ, USA

9. Institute for Control of Biological Products, National Institutes for Food and Drug Control, Beijing, China

10. Directors Office, Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong, China

Funder

Merck Sharp & Dohme LLC

Publisher

Informa UK Limited

Reference26 articles.

1. World Health Organization. Rotavirus. [accessed 2023 Sep 19]. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccines-quality/rotavirus.

2. Rotavirus Vaccination and the Global Burden of Rotavirus Diarrhea Among Children Younger Than 5 Years

3. Rotavirus-specific and Overall Diarrhea Mortality in Chinese Children Younger than 5 Years

4. The Public Health Burden of Rotavirus Disease in Children Younger Than Five Years and Considerations for Rotavirus Vaccine Introduction in China

5. Rotavirus vaccines: WHO position paper – July 2021;World Health Organization;Wkly Epidemiol Rec

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