Effectiveness of the oral rotavirus vaccine ROTASIIL among children hospitalized with acute gastroenteritis in India
ROTASIIL®, a pentavalent oral rotavirus vaccine licensed in India in 2017, was introduced into the Universal Immunization Program in 2018. Primary endpoint was vaccine effectiveness (VE) against moderate and severe rotavirus gastroenteritis (RVGE) in children <2 years using pooled data from two multi-center observational studies across 32 hospitals in seven states (July 2019–December 2023). A test-negative case–control design estimated adjusted VE (aVE) for three ROTASIIL® doses. Among 2,243 children aged 3–23 months hospitalized with acute gastroenteritis, 638 were ELISA-positive. For completed series (three doses), the aVE against hospitalization due to RVGE among children aged 3–23 months was 52% (95% CI, 32–66), with the highest aVE of 88% (CI, 53–97) observed among those aged 3-5 months. The aVE against moderate RVGE was 56% (CI, 11-79), and that of severe RVGE was 54% (CI, 31-70). The highest genotype-specific aVE was 62% (CI, 29-80) against G1P[8]. For at least one dose, the aVE was 45% (CI, 26–60) among children aged 1–23 months. A completed series of ROTASIIL® effectively reduced RVGE hospitalizations especially with a higher VE observed in younger age groups, suggesting the benefits of timely immunization. Here, using pooled data from two multi-center observational studies, the authors analyze the effectiveness of the ROTASIIL® vaccine in protecting young children against moderate to severe rotavirus diarrhea, finding that three doses of this vaccine provided good protection, especially among younger children, highlighting the need for timely and complete vaccination.
Authors
- Rose Xavier (ORCID: https://orcid.org/0000-0002-1784-3878)
- Aparna Namboodiripad (ORCID: https://orcid.org/0000-0002-9847-1518)
- Kishor G Rathod (ORCID: https://orcid.org/0000-0002-6421-0395)
- Tushar Tewari (ORCID: https://orcid.org/0000-0001-5842-8622)
- Priyadarishini Dorairaj
- Kamalakshi G. Bhat (ORCID: https://orcid.org/0000-0003-4226-0727)
- Yuxiao Tang (ORCID: https://orcid.org/0000-0001-7576-8928)
- Indranil Choudhury (ORCID: https://orcid.org/0009-0001-8506-8543)
- Sidhartha Giri (ORCID: https://orcid.org/0000-0003-3927-7392)
- Namrata Kharat (ORCID: https://orcid.org/0009-0001-9347-9836)
- Ragavi Lingam (ORCID: https://orcid.org/0009-0002-7237-8160)
- Illalu Shivananda
- Rashmi Arora
- Niranjan Bhat (ORCID: https://orcid.org/0000-0001-9249-5028)
- Santhosh Kumar Ganesan (ORCID: https://orcid.org/0009-0007-8805-2559)
- Prasantajyoti Mohanty (ORCID: https://orcid.org/0000-0002-0422-5261)
- Pravakar Mishra (ORCID: https://orcid.org/0000-0002-5546-5425)
- Venkata Raghava Mohan (ORCID: https://orcid.org/0000-0001-5787-7223)
- Gagandeep Kang (ORCID: https://orcid.org/0000-0002-3656-564X)
- Subal Kumar Pradhan (ORCID: https://orcid.org/0000-0001-8570-1348)
- Poovarasan Kannan (ORCID: https://orcid.org/0009-0002-9921-3980)
- Shermin Nasreen Abdul Jaleel (ORCID: https://orcid.org/0009-0004-9423-9094)
- Anupama Machathi (ORCID: https://orcid.org/0009-0008-2053-4209)
- Wari Prakash
- Ayyappan Vellathur Ramasamy (ORCID: https://orcid.org/0009-0002-1660-3204)
- Girish Kumar Chethrapilly Purushothaman
- Haseeb Mohammad
- Charul Mehta
- Rajib Ray
- Ashish Dhongade
- Alka Jadhav
- Madhuri Engade
- Bikash Kumar
- Hassan Sreenivasa Murthy Rajani
- Yashwant Gabhale
- Nuthan Kamat
- Pankaj Buch
- Tintu Varghese
- Jacqueline E. Tate
- Varsha Sudhir Chaudhary
- Bhadresh Vyas
- Sarfaraz Ahmed
- Dewesh Kumar
- Rajesh Chudasama
- Rishabh Rana
- Fiji Madonna Devassikutty
- Amita Surana
- Prasanna Samuel
- Avinash Kumar
- Ajith Kumar
- Vidya Sagar
- the site collaborators of the study network
- Gargi Pathak
- Poonam Singh
- Niranjana Mahantashetti
- Priya Sreenivasan
Institutions
- JSS Academy of Higher Education and Research (IN)
- Centers for Disease Control and Prevention (US)
- Government Medical College (IN)
- Program for Appropriate Technology in Health (US)
- Manipal Academy of Higher Education (IN)
- Christian Medical College, Vellore (IN)
- Government Medical College (IN)
- Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College (IN)
- Jubilee Mission Medical College and Research Institute (IN)
- Tamil Nadu Dr. M.G.R. Medical University (IN)
- Translational Health Science and Technology Institute (IN)
- Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital Kolhapur (IN)
- Rajendra Institute of Medical Sciences (IN)
- Sriram Chandra Bhanja Medical College Hospital (IN)
- Sardar Vallabhbhai National Institute of Technology Surat (IN)
- Dr. D. Y. Patil Medical College, Hospital and Research Centre (IN)
- Government Medical College and Hospital (IN)
- National Institute of Epidemiology (IN)
- Sparsh Hospital (IN)
- Government College Kodanchery (IN)
- KLE Society Hospital (IN)
- Institute of Child Health (IN)
- Institute of Nephro Urology (IN)
- Shaheed Suhrawardy Medical College (BD)
- M. P. Shah Medical College (IN)
- B.J. Medical College (IN)
- Vinoba Bhave University (IN)
- Karnataka Institute of Medical Sciences (IN)
- JSS Medical College and Hospital (IN)
Publication Details
- Journal
- Nature Communications
- Published
- 2026-09-15
- DOI
- https://doi.org/10.1038/s41467-026-77663-1
- Primary Topic
- Viral gastroenteritis research and epidemiology
- Type
- article
- Field-Weighted Citation Impact
- 0.00