Safety of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old
•About 42% of infants who received MenACWY-CRM had an indicated high-risk condition.•After vaccination, 29% had an incident condition in emergency/hospital visits.•Fever and upper respiratory infections were most common.•Incident emergency/hospital visit rates were comparable to background rates.•Th...
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| Veröffentlicht in: | Vaccine 2020-01, Vol.38 (2), p.228-234 |
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| creator | Becerra-Culqui, Tracy A. Sy, Lina S. Ackerson, Bradley K. Slezak, Jeff M. Luo, Yi Fischetti, Christine A. Ohadike, Yvonne U. Curina, Carlo Pellegrini, Michele Solano, Zendi Tartof, Sara Y. Tseng, Hung Fu |
| description | •About 42% of infants who received MenACWY-CRM had an indicated high-risk condition.•After vaccination, 29% had an incident condition in emergency/hospital visits.•Fever and upper respiratory infections were most common.•Incident emergency/hospital visit rates were comparable to background rates.•There are no safety concerns from the conduct of this post-licensure safety study.
The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is recommended for 2–23 month-old infants/toddlers at increased risk for meningococcal disease. This study adds to the current knowledge of MenACWY-CRM safety among this age group in a clinical care setting.
Kaiser Permanente Southern California members aged 2–23 months who received MenACWY-CRM between July 2014 and June 2017 were included. Electronic health records were searched for emergency department (ED) and hospitalization encounters, and diagnoses associated with these visits up to 6 months after each dose.
There were 138 infants/toddlers who received MenACWY-CRM, with 59.4% being African American and 66.7% receiving only one dose. Most infants either had a high-risk condition (i.e., anatomic/functional asplenia or DiGeorge syndrome) (42.0%), or a travel indication (54.3%). The incidence rate of ED visits was 0.6/person-year (95% confidence interval [CI]: 0.5–0.8), 0.4/person-year (CI: 0.3–0.5) for hospitalizations, and 0.1/person-year (CI: 0.1–0.3) for ED to hospital transfers. Overall, 29.0% of recipients had an incident diagnosis in the ED or hospital setting. Fever and acute upper respiratory infections were the most common diagnoses, with 46 out of 47 diagnoses occurring among infants with high-risk conditions.
Data from this descriptive observational study do not suggest safety concerns associated with MenACWY-CRM when used as part of clinical care of 2–23 month-old infants/toddlers indicated for vaccination. |
| doi_str_mv | 10.1016/j.vaccine.2019.10.024 |
| format | Article |
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The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is recommended for 2–23 month-old infants/toddlers at increased risk for meningococcal disease. This study adds to the current knowledge of MenACWY-CRM safety among this age group in a clinical care setting.
Kaiser Permanente Southern California members aged 2–23 months who received MenACWY-CRM between July 2014 and June 2017 were included. Electronic health records were searched for emergency department (ED) and hospitalization encounters, and diagnoses associated with these visits up to 6 months after each dose.
There were 138 infants/toddlers who received MenACWY-CRM, with 59.4% being African American and 66.7% receiving only one dose. Most infants either had a high-risk condition (i.e., anatomic/functional asplenia or DiGeorge syndrome) (42.0%), or a travel indication (54.3%). The incidence rate of ED visits was 0.6/person-year (95% confidence interval [CI]: 0.5–0.8), 0.4/person-year (CI: 0.3–0.5) for hospitalizations, and 0.1/person-year (CI: 0.1–0.3) for ED to hospital transfers. Overall, 29.0% of recipients had an incident diagnosis in the ED or hospital setting. Fever and acute upper respiratory infections were the most common diagnoses, with 46 out of 47 diagnoses occurring among infants with high-risk conditions.
Data from this descriptive observational study do not suggest safety concerns associated with MenACWY-CRM when used as part of clinical care of 2–23 month-old infants/toddlers indicated for vaccination.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2019.10.024</identifier><identifier>PMID: 31648912</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Age ; Asplenia ; Automation ; Clinical trials ; Codes ; Confidence intervals ; Conjugates ; Demographics ; Disease ; Electronic health records ; Electronic medical records ; Emergency medical services ; Emergency Service, Hospital - statistics & numerical data ; Epidemics ; Female ; Fever ; HIV ; Hospitalization ; Hospitalization - statistics & numerical data ; Hospitals ; Human immunodeficiency virus ; Humans ; Immunization ; Infant ; Infants ; Male ; Meningococcal conjugate vaccine ; Meningococcal disease ; Meningococcal Infections - prevention & control ; Meningococcal Vaccines - administration & dosage ; Meningococcal Vaccines - adverse effects ; Observational studies ; Observational study ; Pre-existing conditions ; Preschool children ; Respiratory system ; Risk ; Safety ; Thymic hypoplasia ; Toddlers ; Vaccination ; Vaccines ; Vaccines, Conjugate - administration & dosage ; Vaccines, Conjugate - adverse effects</subject><ispartof>Vaccine, 2020-01, Vol.38 (2), p.228-234</ispartof><rights>2019 The Authors</rights><rights>Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><rights>2019. The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-24e051187ff1d953d9870f14c65991b19bca40030b05eafdd2f195110115e1173</citedby><cites>FETCH-LOGICAL-c440t-24e051187ff1d953d9870f14c65991b19bca40030b05eafdd2f195110115e1173</cites><orcidid>0000-0002-3536-124X ; 0000-0002-6108-9198 ; 0000-0001-8505-9260 ; 0000-0002-8957-5155 ; 0000-0002-0816-7345</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2330964471?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,778,782,3539,27911,27912,45982,64370,64374,72224</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31648912$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Becerra-Culqui, Tracy A.</creatorcontrib><creatorcontrib>Sy, Lina S.</creatorcontrib><creatorcontrib>Ackerson, Bradley K.</creatorcontrib><creatorcontrib>Slezak, Jeff M.</creatorcontrib><creatorcontrib>Luo, Yi</creatorcontrib><creatorcontrib>Fischetti, Christine A.</creatorcontrib><creatorcontrib>Ohadike, Yvonne U.</creatorcontrib><creatorcontrib>Curina, Carlo</creatorcontrib><creatorcontrib>Pellegrini, Michele</creatorcontrib><creatorcontrib>Solano, Zendi</creatorcontrib><creatorcontrib>Tartof, Sara Y.</creatorcontrib><creatorcontrib>Tseng, Hung Fu</creatorcontrib><title>Safety of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>•About 42% of infants who received MenACWY-CRM had an indicated high-risk condition.•After vaccination, 29% had an incident condition in emergency/hospital visits.•Fever and upper respiratory infections were most common.•Incident emergency/hospital visit rates were comparable to background rates.•There are no safety concerns from the conduct of this post-licensure safety study.
The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is recommended for 2–23 month-old infants/toddlers at increased risk for meningococcal disease. This study adds to the current knowledge of MenACWY-CRM safety among this age group in a clinical care setting.
Kaiser Permanente Southern California members aged 2–23 months who received MenACWY-CRM between July 2014 and June 2017 were included. Electronic health records were searched for emergency department (ED) and hospitalization encounters, and diagnoses associated with these visits up to 6 months after each dose.
There were 138 infants/toddlers who received MenACWY-CRM, with 59.4% being African American and 66.7% receiving only one dose. Most infants either had a high-risk condition (i.e., anatomic/functional asplenia or DiGeorge syndrome) (42.0%), or a travel indication (54.3%). The incidence rate of ED visits was 0.6/person-year (95% confidence interval [CI]: 0.5–0.8), 0.4/person-year (CI: 0.3–0.5) for hospitalizations, and 0.1/person-year (CI: 0.1–0.3) for ED to hospital transfers. Overall, 29.0% of recipients had an incident diagnosis in the ED or hospital setting. Fever and acute upper respiratory infections were the most common diagnoses, with 46 out of 47 diagnoses occurring among infants with high-risk conditions.
Data from this descriptive observational study do not suggest safety concerns associated with MenACWY-CRM when used as part of clinical care of 2–23 month-old infants/toddlers indicated for vaccination.</description><subject>Age</subject><subject>Asplenia</subject><subject>Automation</subject><subject>Clinical trials</subject><subject>Codes</subject><subject>Confidence intervals</subject><subject>Conjugates</subject><subject>Demographics</subject><subject>Disease</subject><subject>Electronic health records</subject><subject>Electronic medical records</subject><subject>Emergency medical services</subject><subject>Emergency Service, Hospital - statistics & numerical data</subject><subject>Epidemics</subject><subject>Female</subject><subject>Fever</subject><subject>HIV</subject><subject>Hospitalization</subject><subject>Hospitalization - statistics & numerical data</subject><subject>Hospitals</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Immunization</subject><subject>Infant</subject><subject>Infants</subject><subject>Male</subject><subject>Meningococcal conjugate vaccine</subject><subject>Meningococcal disease</subject><subject>Meningococcal Infections - prevention & control</subject><subject>Meningococcal Vaccines - administration & dosage</subject><subject>Meningococcal Vaccines - adverse effects</subject><subject>Observational studies</subject><subject>Observational study</subject><subject>Pre-existing conditions</subject><subject>Preschool children</subject><subject>Respiratory system</subject><subject>Risk</subject><subject>Safety</subject><subject>Thymic hypoplasia</subject><subject>Toddlers</subject><subject>Vaccination</subject><subject>Vaccines</subject><subject>Vaccines, Conjugate - administration & dosage</subject><subject>Vaccines, Conjugate - adverse 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of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old</title><author>Becerra-Culqui, Tracy A. ; Sy, Lina S. ; Ackerson, Bradley K. ; Slezak, Jeff M. ; Luo, Yi ; Fischetti, Christine A. ; Ohadike, Yvonne U. ; Curina, Carlo ; Pellegrini, Michele ; Solano, Zendi ; Tartof, Sara Y. ; Tseng, Hung Fu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c440t-24e051187ff1d953d9870f14c65991b19bca40030b05eafdd2f195110115e1173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Age</topic><topic>Asplenia</topic><topic>Automation</topic><topic>Clinical trials</topic><topic>Codes</topic><topic>Confidence intervals</topic><topic>Conjugates</topic><topic>Demographics</topic><topic>Disease</topic><topic>Electronic health records</topic><topic>Electronic medical records</topic><topic>Emergency medical services</topic><topic>Emergency Service, Hospital - statistics & numerical data</topic><topic>Epidemics</topic><topic>Female</topic><topic>Fever</topic><topic>HIV</topic><topic>Hospitalization</topic><topic>Hospitalization - statistics & numerical data</topic><topic>Hospitals</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Immunization</topic><topic>Infant</topic><topic>Infants</topic><topic>Male</topic><topic>Meningococcal conjugate vaccine</topic><topic>Meningococcal disease</topic><topic>Meningococcal Infections - prevention & control</topic><topic>Meningococcal Vaccines - administration & dosage</topic><topic>Meningococcal Vaccines - adverse effects</topic><topic>Observational studies</topic><topic>Observational study</topic><topic>Pre-existing conditions</topic><topic>Preschool children</topic><topic>Respiratory system</topic><topic>Risk</topic><topic>Safety</topic><topic>Thymic hypoplasia</topic><topic>Toddlers</topic><topic>Vaccination</topic><topic>Vaccines</topic><topic>Vaccines, Conjugate - 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Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Becerra-Culqui, Tracy A.</au><au>Sy, Lina S.</au><au>Ackerson, Bradley K.</au><au>Slezak, Jeff M.</au><au>Luo, Yi</au><au>Fischetti, Christine A.</au><au>Ohadike, Yvonne U.</au><au>Curina, Carlo</au><au>Pellegrini, Michele</au><au>Solano, Zendi</au><au>Tartof, Sara Y.</au><au>Tseng, Hung Fu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2020-01-10</date><risdate>2020</risdate><volume>38</volume><issue>2</issue><spage>228</spage><epage>234</epage><pages>228-234</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>•About 42% of infants who received MenACWY-CRM had an indicated high-risk condition.•After vaccination, 29% had an incident condition in emergency/hospital visits.•Fever and upper respiratory infections were most common.•Incident emergency/hospital visit rates were comparable to background rates.•There are no safety concerns from the conduct of this post-licensure safety study.
The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is recommended for 2–23 month-old infants/toddlers at increased risk for meningococcal disease. This study adds to the current knowledge of MenACWY-CRM safety among this age group in a clinical care setting.
Kaiser Permanente Southern California members aged 2–23 months who received MenACWY-CRM between July 2014 and June 2017 were included. Electronic health records were searched for emergency department (ED) and hospitalization encounters, and diagnoses associated with these visits up to 6 months after each dose.
There were 138 infants/toddlers who received MenACWY-CRM, with 59.4% being African American and 66.7% receiving only one dose. Most infants either had a high-risk condition (i.e., anatomic/functional asplenia or DiGeorge syndrome) (42.0%), or a travel indication (54.3%). The incidence rate of ED visits was 0.6/person-year (95% confidence interval [CI]: 0.5–0.8), 0.4/person-year (CI: 0.3–0.5) for hospitalizations, and 0.1/person-year (CI: 0.1–0.3) for ED to hospital transfers. Overall, 29.0% of recipients had an incident diagnosis in the ED or hospital setting. Fever and acute upper respiratory infections were the most common diagnoses, with 46 out of 47 diagnoses occurring among infants with high-risk conditions.
Data from this descriptive observational study do not suggest safety concerns associated with MenACWY-CRM when used as part of clinical care of 2–23 month-old infants/toddlers indicated for vaccination.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>31648912</pmid><doi>10.1016/j.vaccine.2019.10.024</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-3536-124X</orcidid><orcidid>https://orcid.org/0000-0002-6108-9198</orcidid><orcidid>https://orcid.org/0000-0001-8505-9260</orcidid><orcidid>https://orcid.org/0000-0002-8957-5155</orcidid><orcidid>https://orcid.org/0000-0002-0816-7345</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2020-01, Vol.38 (2), p.228-234 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_proquest_journals_2330964471 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Age Asplenia Automation Clinical trials Codes Confidence intervals Conjugates Demographics Disease Electronic health records Electronic medical records Emergency medical services Emergency Service, Hospital - statistics & numerical data Epidemics Female Fever HIV Hospitalization Hospitalization - statistics & numerical data Hospitals Human immunodeficiency virus Humans Immunization Infant Infants Male Meningococcal conjugate vaccine Meningococcal disease Meningococcal Infections - prevention & control Meningococcal Vaccines - administration & dosage Meningococcal Vaccines - adverse effects Observational studies Observational study Pre-existing conditions Preschool children Respiratory system Risk Safety Thymic hypoplasia Toddlers Vaccination Vaccines Vaccines, Conjugate - administration & dosage Vaccines, Conjugate - adverse effects |
| title | Safety of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-16T00%3A28%3A47IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Safety%20of%20quadrivalent%20meningococcal%20conjugate%20vaccine%20in%20infants%20and%20toddlers%202%20to%2023-months%20old&rft.jtitle=Vaccine&rft.au=Becerra-Culqui,%20Tracy%20A.&rft.date=2020-01-10&rft.volume=38&rft.issue=2&rft.spage=228&rft.epage=234&rft.pages=228-234&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2019.10.024&rft_dat=%3Cproquest_cross%3E2330964471%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2330964471&rft_id=info:pmid/31648912&rft_els_id=S0264410X19313878&rfr_iscdi=true |