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Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study
Yue Xin Xiu1, Lin Tang1, Fu Zhen Wang1
1National 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.
Insights
The pentavalent rotavirus vaccine (RV5) shows strong effectiveness in preventing rotavirus gastroenteritis in children under five. Three doses offer better protection than one or two, with effectiveness remaining high even a year after the third dose.
Area of Science:
- Pediatrics
- Vaccinology
- Infectious Diseases
Background:
- Rotavirus gastroenteritis (RVGE) is a significant cause of acute gastroenteritis (AGE) in children globally.
- The pentavalent rotavirus vaccine (RV5) is a key tool for preventing RVGE.
Purpose of the Study:
- To evaluate the vaccine effectiveness (VE) of the RV5 vaccine in children under five years old in China.
- To assess the impact of the number of vaccine doses and time since vaccination on VE.
Main Methods:
- A propensity score-matched test-negative case-control study was conducted.
- Data were sourced from electronic health records and immunization information systems.
- Children with AGE were matched based on age, visit month, and province.
Main Results:
- Three doses of RV5 showed higher VE (67.2%) against medically attended RV infection compared to 1-2 doses (57.6%).
- VE remained substantial (63.0%) at least one year after the third dose in children vaccinated before five months of age.
- Three-dose VE was higher for RVGE hospitalizations (69.4%) than for outpatient visits (57.5%).
Conclusions:
- The three-dose RV5 regimen provides robust protection against RVGE in young children.
- Vaccine effectiveness is durable over time and higher for severe outcomes like hospitalization.
- Findings support continued use and optimal administration schedules for RV5 in China.
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.
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