Intussusception after Rotavirus Vaccine Introduction in India
| Autor: | Suresh Goyal, Balasubramanian Sundaram, Kulandaivel Murugiah, Sunita Bidari, Prasantajyoti Mohanty, Gagandeep Kang, Rajendra P Gorthi, Mannancheril A Mathew, Vineeta Gupta, Nayana P Nair, Hemant Jain, Suraj Chawla, Hemanthkumar Boopathy, Gopinath Vinayagamurthy, Rajkumar Gupta, Samarasimha N Reddy, Pramod Sharma, Sambandan Kumaravel, Muthukumaran Jagannatham, Mohan D Gupte, Saroj Sathpathy, Ira Praharaj, Raghul Maniam, Ashwitha Shenoy, Jacqueline E Tate, Venkata R Mohan, Girish K C Purushothaman, Geeta Gathwala, Sudhir Babji, Hiranya Mohanty, Jayanta K Goswami, Sowmiya Senthamizh, Vittal Mohan, Madhu Gupta, Umesh D Parashar, Krishna B Goru, Priyadarishini Dorairaj, Tarun J K Jacob, Rashmi Arora, Nirmal Kumar Mohakud, Padmalatha Pamu, Rajib Kumar Ray, Sidhartha Giri, Ashish Wakhlu, Manohar Badur, Suhasini Mekala, Mrutunjay Dash, Rajamani Gurusamy, Varunkumar Thiyagarajan, Bhaskar Reddy |
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| Rok vydání: | 2020 |
| Předmět: |
Rotavirus
Male Risk Pediatrics medicine.medical_specialty Immunization Secondary MEDLINE India Administration Oral 030204 cardiovascular system & hematology Vaccines Attenuated Article Rotavirus Infections 03 medical and health sciences 0302 clinical medicine Intussusception (medical disorder) Product Surveillance Postmarketing medicine Humans 030212 general & internal medicine Vaccines business.industry Incidence Vaccination Rotavirus Vaccines Infant General Medicine medicine.disease Rotavirus vaccine Case-Control Studies Immunization program Female Safety business Intussusception Infants |
| Zdroj: | The New England Journal of Medicine |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa2002276 |
| Popis: | A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries.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.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.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.). |
| Databáze: | OpenAIRE |
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