Intussusception after Rotavirus Vaccine Introduction in India.
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Reddy Samarasimha N, Nair Nayana P, Tate Jacqueline E, Thiyagarajan Varunkumar, Giri Sidhartha, Praharaj Ira, Mohan Venkata R, Babji Sudhir, Gupte Mohan D, Arora Rashmi, Bidari Sunita, Senthamizh Sowmiya, Mekala Suhasini, Goru Krishna B, Reddy Bhaskar, Pamu Padmalatha, Gorthi Rajendra P, Badur Manohar, Mohan Vittal, Sathpathy Saroj, Mohanty Hiranya, Dash Mrutunjay, Mohakud Nirmal K, Ray Rajib K, Mohanty Prasantajyoti, Gathwala Geeta, Chawla Suraj, Gupta Madhu, Gupta Rajkumar, Goyal Suresh, Sharma Pramod, Mathew Mannancheril A, Jacob Tarun J K, Sundaram Balasubramanian, Purushothaman Girish K C, Dorairaj Priyadarishini, Jagannatham Muthukumaran, Murugiah Kulandaivel, Boopathy Hemanthkumar, Maniam Raghul, Gurusamy Rajamani, Kumaravel Sambandan, Shenoy Ashwitha, Jain Hemant, Goswami Jayanta K, Wakhlu Ashish, Gupta Vineeta, Vinayagamurthy Gopinath, Parashar Umesh D, Kang Gagandeep
Аннотация
METHODS: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location.
RESULTS: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis.
CONCLUSIONS: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).