Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis

Autor: Pradeep K. Jena, Simmi K. Ratan, Patrick L.F. Zuber, Rashmi Shad, G Rajamani, Jothilakshmi. K., Javeed Iqbal Bhat, Mahesh Kumar Aggarwal, Lalit Sankhe, Pradeep Haldar, John Mathai, Lalit Bharadia, Arindam Ray, Jimmy Shad, Neelam Mohan, Narendra Behera, Atul Gupta, Arun Dash, Krishnaswamy R, Jan Bonhoeffer, Saurabh Garge, Cenita J. Sam, Bashir Ahmad Charoo, M. K. Ajayakumar, Ruchirendu Sarkar, Jacqueline E. Tate, Ramesh Poluru, Jayanta K. Goswami, Harish Kumar S, Gowhar Nazir Mufti, A Santosh Kumar, Narendra K. Arora, Bikasha Bihary Tripathy, Ashish Wakhlu, Satya Sundar G. Mohapatra, Subrat Kumar Sahoo, Vijayendra Kumar, Sushant Mane, Sanjib K. Debbarma, Bhadresh Vyas, Pavai Arunachalam, Anand Prakash Dubey, Padmalatha. P., Manoja Kumar Das, Rakesh Kumar, Umesh D. Parashar, Sunil K. Ghosh, Meera Luthra, Apoorva Sharan, Rachita Sarangi, Nihar Ranjan Sarkar, K. Kameswari, G. Rajendra Prasad, J. Shyamala, Christine Maure, Kaushik Lahiri, Harsh Trivedi, Suman Sarkar, Bini Gupta
Rok vydání: 2020
Předmět:
Pediatrics
Relative incidence
Rotavirus vaccination
0302 clinical medicine
Vaccination status
Intussusception (medical disorder)
RI
Relative incidence
Medicine
MIC
Middle income countries
030212 general & internal medicine
Prospective Studies
Child
Vaccination
NIP
National immunization programmes
Rotavirus vaccine
CRF
Case record form
Infectious Diseases
LMIC
Low and middle income countries
Child
Preschool
Molecular Medicine
SCCS
Self-controlled case series
Adult
Vaccine safety
medicine.medical_specialty
Adolescent
030231 tropical medicine
India
CAC
Case Adjudication Committee
RR
Relative risk
Rotavirus Infections
Article
WHO
World Health Organization
03 medical and health sciences
Young Adult
RV1
Monovalent rotavirus vaccine (Rotarix™)
Humans
General Veterinary
General Immunology and Microbiology
business.industry
CI
Confidence interval
Public Health
Environmental and Occupational Health
Rotavirus Vaccines
Infant
RVV
Rotavirus vaccine
IQR
Interquartile range
medicine.disease
Self-controlled case-series
Confidence interval
Rotavac
ICD
International Classification of Diseases
TAG
Technical Advisory Group
Increased risk
RV5
Pentavalent rotavirus vaccine (Rotateq™)
business
Intussusception
Zdroj: Vaccine
ISSN: 1873-2518
Popis: Background An association between rotavirus vaccination and intussusception has been documented in post-licensure studies in some countries. We evaluated the risk of intussusception associated with monovalent rotavirus vaccine (Rotavac) administered at 6, 10 and 14 weeks of age in India. Methods Active prospective surveillance for intussusception was conducted at 22 hospitals across 16 states from April 2016 through September 2017. Data on demography, clinical features and vaccination were documented. Age-adjusted relative incidence for 1–7, 8–21, and 1–21 days after rotavirus vaccination in children aged 28–364 days at intussusception onset was estimated using the self-controlled case-series (SCCS) method. Only Brighton Collaboration level 1 cases were included. Results Out of 670 children aged 2–23 months with intussusception, 311 (46.4%) children were aged 28–364 days with confirmed vaccination status. Out of these, 52 intussusception cases with confirmed receipt of RVV were included in the SCCS analysis. No intussusception case was observed within 21 days of dose 1. Only one case occurred during 8–21 days after the dose 2. Post-dose 3, two cases in 1–7 days and 7 cases during 8–21 days period were observed. There was no increased risk of intussusception during 1–7 days after the doses 1 and 2 (zero cases observed) or dose 3 (relative incidence [RI], 1.71 [95% confidence interval {CI} 0.0–5.11]). Similarly, no increased risk during 8–21 days after the dose 1 (zero cases observed), dose 2 (RI, 0.71 [95% CI, 0.0–3.28]) or dose 3 (RI, 2.52 [95% CI, 0.78–5.61]). The results were similar for 1–21 day periods after the doses separately or pooled. Conclusions The risk of intussusception during the first 21 days after any dose of rotavirus vaccine (Rotavac) was not higher among the Indian infants than the background risk, based on limited SCCS analysis of 52 children.
Databáze: OpenAIRE
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