Intussusception after Rotavirus Vaccine Introduction in India

被引：33

作者：

Reddy, S. N. ^{[1
]}

Nair, N. P. ^{[1
]}

Tate, J. E. ^{[37
]}

Thiyagarajan, V ^{[1
]}

Giri, S. ^{[1
,11
]}

Paraharaj, I ^{[1
,11
]}

Mohan, V. R. ^{[2
]}

Babji, S. ^{[1
]}

Gupte, M. D. ^{[12
]}

Arora, R. ^{[12
]}

Bidari, S. ^{[1
]}

Senthamizh, S. ^{[1
]}

Mekala, S. ^{[13
,14
]}

Goru, K. B. ^{[15
,16
]}

Reddy, B. ^{[15
,16
]}

Pamu, P. ^{[17
,18
]}

Gorthi, R. P. ^{[17
,18
]}

Badur, M. ^{[19
]}

Mohan, V ^{[19
]}

Sathpathy, S. ^{[20
]}

Mohanty, H. ^{[20
]}

Dash, M. ^{[21
,22
]}

Mohakud, N. K. ^{[23
]}

Ray, R. K. ^{[24
]}

Mohanty, P. ^{[24
]}

Gathwala, G. ^{[25
]}

Chawla, S. ^{[26
]}

Gupta, M. ^{[27
]}

Gupta, R. ^{[28
]}

Goyal, S. ^{[29
]}

Sharma, P. ^{[30
]}

Mathew, M. A. ^{[31
]}

Jacob, T. J. K. ^{[3
]}

Sundaram, B. ^{[5
]}

Purusothaman, G. K. C. ^{[6
]}

Dorairaj, P. ^{[7
]}

Jagannatham, M. ^{[7
]}

Murugiah, K. ^{[8
,9
]}

Boopathy, H. ^{[8
,9
]}

Maniam, R. ^{[10
]}

Gurusamy, R. ^{[10
]}

Kumaravel, S. ^{[32
]}

Shenoy, A. ^{[32
]}

Jain, H. ^{[33
]}

Goswami, J. K. ^{[34
]}

Wakhlu, A. ^{[35
]}

Gupta, V ^{[36
]}

Vinayagamurthy, G. ^{[4
]}

Parashar, U. D. ^{[37
]}

Kang, G. ^{[1
,12
]}

机构：

[1] Wellcome Trust Res Lab, Div Gastrointestinal Sci, Vellore, Tamil Nadu, India

[2] Dept Community Hlth, Vellore, Tamil Nadu, India

[3] Christian Med Coll Vellore, Vellore, Tamil Nadu, India

[4] Govt Vellore Med Coll, Vellore, Tamil Nadu, India

[5] Kanchi Kamakoti Child Trust Hosp, Chennai, Tamil Nadu, India

[6] Natl Inst Epidemiol, Chennai, Tamil Nadu, India

[7] Inst Child Hlth, Chennai, Tamil Nadu, India

[8] Govt Rajaji Hosp, Madurai, Tamil Nadu, India

[9] Madurai Med Coll, Madurai, Tamil Nadu, India

[10] Coimbatore Med Coll, Coimbatore, Tamil Nadu, India

[11] Indian Council Med Res, New Delhi, India

[12] Translat Hlth Sci & Technol Inst, Faridabad, India

[13] Kurnool Med Coll, Kurnool, Andhra Pradesh, India

[14] Govt Gen Hosp, Kurnool, Andhra Pradesh, India

[15] Govt Gen Hosp, Kakinada, Andhra Pradesh, India

[16] Rangaraya Med Coll, Kakinada, Andhra Pradesh, India

[17] King George Hosp, Visakhapatnam, Andhra Pradesh, India

[18] Andhra Med Coll, Visakhapatnam, Andhra Pradesh, India

[19] Sri Venkateshwara Med Coll, Tirupati, Andhra Pradesh, India

[20] Sardar Valla Bhai Patel Post Grad Inst Paediat, Cuttack, India

[21] Inst Med Sci, Bhubaneswar, India

[22] SUM Hosp, Bhubaneswar, India

[23] Kalinga Inst Med Sci, Bhubaneswar, India

[24] Hitech Hosp, Bhubaneswar, India

[25] Pandit Bhagwat Dayal Sharma Post Grad Inst Med, Rohtak, Haryana, India

[26] Shaheed Hasan Khan Mewati Govt Med Coll, Mewat, India

[27] Post Grad Inst Med Educ & Res, Chandigarh, India

[28] Sawai Man Singh Med Coll, Jaipur, Rajasthan, India

[29] Rabindranath Tagore Med Coll, Udaipur, Rajasthan, India

[30] Dr Sampurnanand Med Coll, Jodhpur, Rajasthan, India

[31] Malankara Orthodox Syrian Church Med Coll Hosp, Kolencherry, Kerala, India

[32] Jawaharlal Nehru Inst Postgrad Med Educ & Res, Pondicherry, India

[33] Mahatma Gandhi Mem Med Coll, Indore, India

[34] Govt Med Coll, Gauhati, Assam, India

[35] King George Med Coll, Lucknow, Uttar Pradesh, India

[36] Banaras Hindu Univ, Inst Med Sci, Varanasi, Uttar Pradesh, India

[37] Ctr Dis Control & Prevent, Atlanta, GA USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2020年 / 383卷 / 20期

关键词：

RISK; INFANTS; EFFICACY; SAFETY; IMMUNIZATION; INFECTION; 116E;

D O I：

10.1056/NEJMoa2002276

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND 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. 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.

引用

页码：1932 / 1940

页数：9

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