Rotavirus vaccine effectiveness and coverage among children younger than 5 years old in Shanghai, China: A test-negative case control study

Xiaohuan Gong; Zhuoying Huang; Yaxu Zheng; Wenjia Xiao; Jiechen Liu; Sheng Lin; Hao Pan; Jian Chen; Huanyu Wu; Weibing Wang

doi:10.1016/j.vaccine.2025.126731

Rotavirus vaccine effectiveness and coverage among children younger than 5 years old in Shanghai, China: A test-negative case control study

Vaccine. 2025 Jan 13:48:126731. doi: 10.1016/j.vaccine.2025.126731. Online ahead of print.

Authors

Xiaohuan Gong¹, Zhuoying Huang², Yaxu Zheng¹, Wenjia Xiao³, Jiechen Liu⁴, Sheng Lin³, Hao Pan³, Jian Chen³, Huanyu Wu³, Weibing Wang⁵

Affiliations

¹ Department of Epidemiology, School of Public Health, Fudan University, Shanghai, China; Division of Infectious Disease Control and Prevention, Shanghai Municipal Center of Disease Control and Prevention, Shanghai, China.
² Department of Epidemiology, School of Public Health, Fudan University, Shanghai, China; Division of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
³ Division of Infectious Disease Control and Prevention, Shanghai Municipal Center of Disease Control and Prevention, Shanghai, China.
⁴ Division of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
⁵ Department of Epidemiology, School of Public Health, Fudan University, Shanghai, China; Key Laboratory of Public Health Safety of Ministry of Education, Fudan University, Shanghai, China. Electronic address: wwb@fudan.edu.cn.

PMID: 39809089
DOI: 10.1016/j.vaccine.2025.126731

Abstract

Objectives: The number of post-marketing studies assessing the vaccine effectiveness (VE) of the Lanzhou lamb rotavirus vaccine (LLR, licensed in 2000 exclusively in China) and the oral human attenuated pentavalent rotavirus vaccine (RotaTeq, licensed in China in 2018) in China is limited.

Methods: A test-negative case-control study based on prospective surveillance was conducted among diarrhea patients aged 5 years and younger at five hospitals in Shanghai, China. Cases and controls were defined based on the results of real-time fluorescent quantitative reverse transcription polymerase chain reaction (rRT-PCR) of fecal samples for rotavirus. Both matched and unmatched case-control study designs were employed using logistic regression models, with adjustments for age at onset age and the rotavirus epidemic season.

Results: In the LLR-specific analysis (247 cases, 2191 controls), the VE of partial LLR vaccination (2 doses) was 49.09 % (95 % CI: 1.69 % ∼ 73.64 %) in multivariate analyses. In the RotaTeq-specific analysis (42 cases and 523 controls), the VE of complete RotaTeq vaccination was 87.13 % (95 % CI: 45.87 % ∼ 96.94 %), 89.46 % (95 % CI: 55.03 % ∼ 97.53 %), and 85.69 % (95 % CI: 33.43 % ∼ 96.93 %) respectively in univariate, multivariate, and matched analyses, respectively. The vaccination coverage for any dose among 2893 patients with rotavirus-negative diarrhea born between 2011 and 2022 was 49.78 %. Following the licensure of RotaTeq in 2018, this coverage increased from 45.02 % to 61.77 %.

Conclusions: RotaTeq demonstrates a robust protective effectiveness, while LLR provides a certain level of protection against mild to moderate rotavirus diarrhea in children in Shanghai. For privately purchased (non-NIP) vaccines, we estimate that the coverage for rotavirus vaccines among children in Shanghai is high. Complete rotavirus vaccination is recommended for age-eligible children. Further post-marketing research on rotavirus vaccines is necessary to inform decision-making regarding the introduction of rotavirus vaccination in China.

Keywords: Rotavirus; Surveillance; Test-negative case-control study; Vaccination coverage; Vaccine effectiveness.