Kang Gagandeep, Lakhkar Anand, Bhamare Chetanraj, Dharmadhikari Abhijeet, Narwadkar Jyoti, Kanujia Arti, Desai Sajjad, Gunale Bhagwat, Poonawalla Cyrus S, Kulkarni Prasad S
Translational Health Science and Technology Institute, Faridabad, India.
Serum Institute of India Pvt. Ltd., Pune, India.
Vaccine X. 2023 Aug 1;15:100362. doi: 10.1016/j.jvacx.2023.100362. eCollection 2023 Dec.
ROTASIIL, an oral live attenuated bovine-human reassortant pentavalent rotavirus vaccine, was approved in 2017. This post-marketing surveillance (PMS) was conducted to collect real-world data on the safety of ROTASIIL in India.
Observational, active PMS was conducted in approximately 10,000 infants aged ≥ 6 weeks. ROTASIIL was administered as a 3-dose regimen, at least 4 weeks apart, beginning at ≥ 6 weeks of age concomitantly with other Expanded Programme on Immunization (EPI) vaccines. Participants were followed for one month after the last dose. The adverse events (AEs) and serious adverse events (SAEs), including intussusception (IS) reported during the follow up period were collected.
A total of 9940 infants were enrolled and were considered for safety analysis. Around 9913 (99.7 %) infants received 2 doses, while 9893 (99.5 %) infants completed all three doses. Total 3693 AEs were reported in 2516 (25.3 %) participants. Most of these AEs were pyrexia (78.01 % of events) and injection-site reactions (19.14 % of events). Nearly all AEs were causally unrelated to orally administered ROTASIIL and could be caused by the concomitant injectable vaccines. Only 4 AEs (2 events of vomiting and 1 event each of discomfort and pyrexia) in 4 (<0.1 %) participants could be related to ROTASIIL. AEs were of mild or moderate severity and all resolved without any sequelae. A total of 2 SAEs (acute otitis media and skull fracture) were reported in 2 (<0.1 %) participants and were not related to ROTASIIL and recovered without sequelae. No case of IS was reported.
ROTASIIL was safe and well tolerated in this study. No safety concerns were reported.
The study was funded by SIIPL which is the manufacturer of the study product.
ROTASIIL是一种口服减毒牛-人重配五价轮状病毒疫苗，于2017年获得批准。开展此次上市后监测（PMS）以收集ROTASIIL在印度安全性的真实世界数据。
对约10000名年龄≥6周的婴儿进行观察性主动PMS。ROTASIIL按3剂程序接种，间隔至少4周，从≥6周龄开始，与其他扩大免疫规划（EPI）疫苗同时接种。在最后一剂接种后对参与者随访1个月。收集随访期间报告的不良事件（AE）和严重不良事件（SAE），包括肠套叠（IS）。
共纳入9940名婴儿并进行安全性分析。约9913名（99.7%）婴儿接种了2剂，9893名（99.5%）婴儿完成了3剂全程接种。2516名（25.3%）参与者共报告了3693起AE。这些AE大多为发热（占事件的78.01%）和注射部位反应（占事件的19.14%）。几乎所有AE与口服ROTASIIL无因果关系，可能由同时接种的注射用疫苗引起。4名（<0.1%）参与者中仅4起AE（2起呕吐事件以及各1起不适和发热事件）可能与ROTASIIL有关。AE为轻度或中度严重程度，均未遗留任何后遗症而缓解。2名（<0.1%）参与者共报告了2起SAE（急性中耳炎和颅骨骨折），与ROTASIIL无关，且未遗留后遗症而康复。未报告IS病例。
本研究中ROTASIIL安全且耐受性良好。未报告安全性问题。
本研究由研究产品制造商SIIPL资助。
