Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of China.

Yue Xin XIU; Lin TANG; Fu Zhen WANG; Lei WANG; Zhen LI; Jun LIU; Dan LI; Xue Yan LI; Yao YI; Fan ZHANG; Lei YU; Jing Feng WU; Zun Dong YIN

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Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of China.

Author: Yue Xin XIU ¹ ; Lin TANG ¹ ; Fu Zhen WANG ¹ ; Lei WANG ² ; Zhen LI ³ ; Jun LIU ⁴ ; Dan LI ² ; Xue Yan LI ³ ; Yao YI ⁴ ; Fan ZHANG ² ; Lei YU ⁵ ; Jing Feng WU ⁴ ; Zun Dong YIN ¹
Author Information

1. National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing 102206, China;National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
2. Hubei Provincial Center for Disease Control and Prevention, Wuhan 437500, Hubei, China.
3. Beijing Municipality Chaoyang District Center for Disease Control and Prevention, Chaoyang District, Beijing 100021, China.
4. Guangdong Provincial Center for Disease Control and Prevention, Guangzhou 511400, Guangdong, China.
5. Department of Hospital Infection Management and Disease Prevention and Control, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing 102206, China.
Publication Type:Journal Article
Keywords: Propensity score matching; Rotavirus vaccine; Test-negative design; Vaccine effectiveness
MeSH: Humans; Rotavirus Vaccines/immunology*; China/epidemiology*; Case-Control Studies; Child, Preschool; Infant; Rotavirus Infections/epidemiology*; Male; Propensity Score; Female; Vaccine Efficacy; Gastroenteritis/virology*; Vaccines, Attenuated; Rotavirus
From: Biomedical and Environmental Sciences 2025;38(9):1032-1043
CountryChina
Language:English
Abstract: OBJECTIVE:The objective of our study was to evaluate the vaccine effectiveness (VE) of the pentavalent rotavirus vaccine (RV5) among < 5-year-old children in three provinces of China during 2020-2024 via a propensity score-matched test-negative case-control study.
METHODS:Electronic health records and immunization information systems were used to obtain data on acute gastroenteritis (AGE) cases tested for rotavirus (RV) infection. RV-positive cases were propensity score matched with RV-negative controls for age, visit month, and province.
RESULTS:The study included 27,472 children with AGE aged 8 weeks to 4 years at the time of AGE diagnosis; 7.98% (2,192) were RV-positive. The VE (95% confidence interval, CI) of 1-2 and 3 doses of RV5 against any medically attended RV infection (inpatient or outpatient) was 57.6% (39.8%, 70.2%) and 67.2% (60.3%, 72.9%), respectively. Among children who received the 3rd dose before turning 5 months of age, 3-dose VE decreased from 70.4% (53.9%, 81.1%) (< 5 months since the 3rd dose) to 63.0% (49.1%, 73.0%) (≥ 1 year since the 3rd dose). The three-dose VE rate was 69.4% (41.3%, 84.0%) for RVGE hospitalization and 57.5% (38.9%, 70.5%) for outpatient-only medically attended RVGE.
CONCLUSION:Three-dose RV5 VE against rotavirus gastroenteritis (RVGE) in children aged < 5 years was higher than 1-2-dose VE. Three-dose VE decreased with time since the 3rd dose in children who received the 3rd dose before turning five months of age, but remained above 60% for at least one year. VE was higher for RVGE hospitalizations than for medically attended outpatient visits.