{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,25]],"date-time":"2026-01-25T04:46:00Z","timestamp":1769316360439,"version":"3.49.0"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2021,1,27]],"date-time":"2021-01-27T00:00:00Z","timestamp":1611705600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1169264"],"award-info":[{"award-number":["OPP1169264"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,8,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>In December 2017, the World Health Organization (WHO) prequalified the first typhoid conjugate vaccine (TCV; Typbar-TCV). While no safety concerns were identified in pre- and postlicensure studies, WHO\u2019s Global Advisory Committee on Vaccine Safety recommended robust safety evaluation with large-scale TCV introductions. During July\u2013August 2018, the Navi Mumbai Municipal Corporation (NMMC) launched the world\u2019s first public sector TCV introduction. Per administrative reports, 113 420 children 9 months\u201314 years old received TCV.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We evaluated adverse events following immunization (AEFIs) using passive and active surveillance via (1) reports from the passive NMMC AEFI surveillance system, (2) telephone interviews with 5% of caregivers of vaccine recipients 48 hours and 7 days postvaccination, and (3) chart abstraction for adverse events of special interest (AESIs) among patients admitted to 5 hospitals using the Brighton Collaboration criteria followed by ascertainment of vaccination status.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We identified 222\/113 420 (0.2%) vaccine recipients with AEFIs through the NMMC AEFI surveillance system: 211 (0.19%) experienced minor AEFIs, 2 (0.002%) severe, and 9 serious (0.008%). At 48 hours postvaccination, 1852\/5605 (33%) caregivers reported \u22651 AEFI, including injection site pain (n\u2005=\u20051452, 26%), swelling (n\u2005=\u2005419, 7.5%), and fever (n\u2005=\u2005416, 7.4%). Of the 4728 interviews completed at 7 days postvaccination, the most reported AEFIs included fever (n\u2005=\u2005200, 4%), pain (n\u2005=\u200552, 1%), and headache (n\u2005=\u200542, 1%). Among 525 hospitalized children diagnosed with an AESI, 60 were vaccinated; no AESIs were causally associated with TCV.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>No unexpected safety signals were identified with TCV introduction. This provides further reassurance for the large-scale use of Typbar-TCV among children 9 months\u201314 years old.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab059","type":"journal-article","created":{"date-parts":[[2021,1,23]],"date-time":"2021-01-23T15:54:31Z","timestamp":1611417271000},"page":"e927-e933","source":"Crossref","is-referenced-by-count":8,"title":["Evaluation of Vaccine Safety After the First Public Sector Introduction of Typhoid Conjugate Vaccine\u2014Navi Mumbai, India, 2018"],"prefix":"10.1093","volume":"73","author":[{"given":"Ashley T","family":"Longley","sequence":"first","affiliation":[{"name":"National Foundation for the Centers for Disease Control and Prevention, Atlanta, Georgia, USA"},{"name":"Global Immunization Division, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kashmira","family":"Date","sequence":"additional","affiliation":[{"name":"Global Immunization Division, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen P","family":"Luby","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Geographic Medicine, Stanford University, Stanford, California,USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pankaj","family":"Bhatnagar","sequence":"additional","affiliation":[{"name":"World Health Organization\u2013Country Office for India, National Public Health Surveillance Project, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adwoa D","family":"Bentsi-Enchill","sequence":"additional","affiliation":[{"name":"Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vineet","family":"Goyal","sequence":"additional","affiliation":[{"name":"World Health Organization\u2013Country Office for India, National Public Health Surveillance Project, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rahul","family":"Shimpi","sequence":"additional","affiliation":[{"name":"World Health Organization\u2013Country Office for India, National Public Health Surveillance Project, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arun","family":"Katkar","sequence":"additional","affiliation":[{"name":"World Health Organization\u2013Country Office for India, National Public Health Surveillance Project, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vijay","family":"Yewale","sequence":"additional","affiliation":[{"name":"Dr Yewale Multi Specialty Hospital for Children, Navi Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niniya","family":"Jayaprasad","sequence":"additional","affiliation":[{"name":"World Health Organization\u2013Country Office for India, National Public Health Surveillance Project, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lily","family":"Horng","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Geographic Medicine, Stanford University, Stanford, California,USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhishek","family":"Kunwar","sequence":"additional","affiliation":[{"name":"World Health Organization\u2013Country Office for India, National Public Health Surveillance Project, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pauline","family":"Harvey","sequence":"additional","affiliation":[{"name":"World Health Organization\u2013Country Office for India, National Public Health Surveillance Project, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pradeep","family":"Haldar","sequence":"additional","affiliation":[{"name":"Ministry of Health and Family Welfare, Government of India, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shanta","family":"Dutta","sequence":"additional","affiliation":[{"name":"National Institute of Cholera and Enteric Diseases, Indian Council of Medical Research, Kolkata, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane F","family":"Gidudu","sequence":"additional","affiliation":[{"name":"Global Immunization Division, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,1,27]]},"reference":[{"key":"2021081616404772100_CIT0001","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1016\/S1473-3099(18)30685-6","article-title":"The global burden of typhoid and paratyphoid fevers: a systematic analysis for the Global Burden of Disease Study 2017","volume":"19","author":"Stanaway","year":"2019","journal-title":"Lancet Infect Dis"},{"key":"2021081616404772100_CIT0002","first-page":"153","article-title":"Typhoid vaccines: WHO position paper\u2014March 2018","volume":"13","author":"World Health Organization","year":"2018","journal-title":"Wkly Epidemiol Rec"},{"key":"2021081616404772100_CIT0003","doi-asserted-by":"crossref","first-page":"705","DOI":"10.1586\/erv.09.40","article-title":"Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS","volume":"8","author":"World Health Organization Global Advisory Committee on Vaccine Safety","year":"2009","journal-title":"Expert Rev Vaccines"},{"key":"2021081616404772100_CIT0004","first-page":"13","article-title":"Global Advisory Commitee on Vaccine Safety, 30 November\u20141 December 2016","volume":"2","author":"World Health Organization","year":"2016","journal-title":"Wkly Epidemiol Rec"},{"key":"2021081616404772100_CIT0005","author":"World Health Organization"},{"key":"2021081616404772100_CIT0006","article-title":"The Brighton Collaboration: creating a global standard for case definitions (and guidelines) for adverse events following immunization","volume-title":"Advances in patient safety: from research to implementation (volume 2: concepts and methodology)","author":"Kohl","year":"2005"},{"key":"2021081616404772100_CIT0007","doi-asserted-by":"crossref","first-page":"5671","DOI":"10.1016\/j.vaccine.2007.02.063","article-title":"The development of standardized case definitions and guidelines for adverse events following immunization","volume":"25","author":"Kohl","year":"2007","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0008","author":"Gavi"},{"key":"2021081616404772100_CIT0009","doi-asserted-by":"crossref","first-page":"S172","DOI":"10.1093\/cid\/ciaa597","article-title":"Decision making and implementation of the first public sector introduction of typhoid conjugate vaccine\u2014Navi Mumbai, India, 2018","volume":"71","author":"Date","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2021081616404772100_CIT0010","author":"World Health Organization"},{"key":"2021081616404772100_CIT0011","doi-asserted-by":"crossref","first-page":"555","DOI":"10.1080\/14760584.2018.1484285","article-title":"Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience","volume":"17","author":"Singh","year":"2018","journal-title":"Expert Rev Vaccines"},{"key":"2021081616404772100_CIT0012","volume-title":"Adverse events following immunization: surveillance and response operational guidelines","author":"Government of India, Ministry of Health and Family Welfare","year":"2015"},{"key":"2021081616404772100_CIT0013","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1016\/j.vaccine.2003.09.008","article-title":"Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation","volume":"22","author":"Bonhoeffer","year":"2004","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0014","doi-asserted-by":"crossref","first-page":"4487","DOI":"10.1016\/j.vaccine.2010.04.041","article-title":"Can the Brighton Collaboration case definitions be used to improve the quality of adverse event following immunization (AEFI) reporting? Anaphylaxis as a case study","volume":"28","author":"Gold","year":"2010","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0015","doi-asserted-by":"crossref","first-page":"5707","DOI":"10.1016\/j.vaccine.2007.02.068","article-title":"Unexplained sudden death, including sudden infant death syndrome (SIDS), in the first and second years of life: case definition and guidelines for collection, analysis, and presentation of immunization safety data","volume":"25","author":"Jorch","year":"2007","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0016","doi-asserted-by":"crossref","first-page":"5771","DOI":"10.1016\/j.vaccine.2007.04.060","article-title":"Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data","volume":"25","author":"Sejvar","year":"2007","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0017","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1016\/j.vaccine.2010.06.003","article-title":"Guillain-Barr\u00e9 syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data","volume":"29","author":"Sejvar","year":"2011","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0018","doi-asserted-by":"crossref","first-page":"5717","DOI":"10.1016\/j.vaccine.2007.02.067","article-title":"Thrombocytopenia: case definition and guidelines for collection, analysis, and presentation of immunization safety data","volume":"25","author":"Wise","year":"2007","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0019","first-page":"45","article-title":"Global Advisory Commitee on Vaccine Safety, 5\u20136 December 2018","volume":"4","author":"World Health Organization","year":"2018","journal-title":"Wkly Epidemiol Rec"},{"key":"2021081616404772100_CIT0020","doi-asserted-by":"crossref","first-page":"386","DOI":"10.1111\/j.1708-8305.2007.00158.x","article-title":"Safety of Typhim Vi vaccine in a postmarketing observational study","volume":"14","author":"Marcus","year":"2007","journal-title":"J Travel Med"},{"key":"2021081616404772100_CIT0021","doi-asserted-by":"crossref","first-page":"6697","DOI":"10.1016\/j.vaccine.2015.10.086","article-title":"A Japanese study to assess immunogenicity and safety of a typhoid Vi polysaccharide vaccine","volume":"33","author":"Miyazu","year":"2015","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0022","author":"Bharat Biotech Intl Ltd"},{"key":"2021081616404772100_CIT0023","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1093\/cid\/civ295","article-title":"Safety and immunogenicity of a Vi polysaccharide-tetanus toxoid conjugate vaccine (Typbar-TCV) in healthy infants, children, and adults in typhoid endemic areas: a multicenter, 2-cohort, open-label, double-blind, randomized controlled phase 3 study","volume":"61","author":"Mohan","year":"2015","journal-title":"Clin Infect Dis"},{"key":"2021081616404772100_CIT0024","doi-asserted-by":"crossref","first-page":"2209","DOI":"10.1056\/NEJMoa1905047","article-title":"Phase 3 efficacy analysis of a typhoid conjugate vaccine trial in Nepal","volume":"381","author":"Shakya","year":"2019","journal-title":"N Engl J Med"},{"key":"2021081616404772100_CIT0025","doi-asserted-by":"crossref","first-page":"3518","DOI":"10.1016\/j.vaccine.2020.03.028","article-title":"Adverse events following immunization with typhoid conjugate vaccine in an outbreak setting in Hyderabad, Pakistan","volume":"38","author":"Qamar","year":"2020","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0026","doi-asserted-by":"crossref","first-page":"B46","DOI":"10.1016\/j.vaccine.2011.12.112","article-title":"Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010","volume":"30(Suppl 2)","author":"Ouandaogo","year":"2012","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0027","doi-asserted-by":"crossref","first-page":"A72","DOI":"10.1016\/j.vaccine.2007.04.045","article-title":"Monitoring of adverse events during the 2003 mass vaccination campaign with a trivalent meningococcal A\/C\/W135 polysaccharide vaccine in Burkina Faso","volume":"25(Suppl 1)","author":"Bentsi-Enchill","year":"2007","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0028","doi-asserted-by":"crossref","first-page":"973","DOI":"10.1080\/21645515.2019.1565259","article-title":"Immunogenicity and safety of an intramuscular split-virion quadrivalent inactivated influenza vaccine in individuals aged \u2265 6 months in India","volume":"15","author":"Agarkhedkar","year":"2019","journal-title":"Hum Vaccin Immunother"},{"key":"2021081616404772100_CIT0029","doi-asserted-by":"crossref","first-page":"2701","DOI":"10.1016\/j.vaccine.2009.02.044","article-title":"Safety and immunogenicity of a measles-mumps-rubella-varicella vaccine given as a second dose in children up to six years of age","volume":"27","author":"Halperin","year":"2009","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0030","doi-asserted-by":"crossref","first-page":"2067","DOI":"10.1016\/S0264-410X(98)00410-1","article-title":"Subcutaneous versus intramuscular injection for booster DT vaccination of adolescents","volume":"17","author":"Mark","year":"1999","journal-title":"Vaccine"},{"key":"2021081616404772100_CIT0031","volume-title":"Supplementary information on vaccine safety, Part 2: Background rates of adverse events following immunization","author":"World Health Organization"},{"key":"2021081616404772100_CIT0032","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1542\/peds.2010-0665","article-title":"Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures","volume":"126","author":"Klein","year":"2010","journal-title":"Pediatrics"},{"key":"2021081616404772100_CIT0033","doi-asserted-by":"crossref","first-page":"809","DOI":"10.1542\/peds.2011-3198","article-title":"Measles-containing vaccines and febrile seizures in children age 4 to 6 years","volume":"129","author":"Klein","year":"2012","journal-title":"Pediatrics"},{"key":"2021081616404772100_CIT0034","author":"World Health Organization"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciab059\/37376949\/ciab059.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/cid\/article-pdf\/73\/4\/e927\/39763864\/ciab059.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/cid\/article-pdf\/73\/4\/e927\/39763864\/ciab059.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,16]],"date-time":"2021-08-16T16:54:35Z","timestamp":1629132875000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/73\/4\/e927\/6121264"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,27]]},"references-count":34,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2021,1,27]]},"published-print":{"date-parts":[[2021,8,16]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciab059","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,8,15]]},"published":{"date-parts":[[2021,1,27]]}}}