The tolerability of a combined hepatitis A and typhoid vaccine in children aged 2–16 years: an observational study

Background: Combined hepatitis A and typhoid vaccines have been widely used globally and proven to be safe, well tolerated and efficacious in adults. The combined hepatitis A and typhoid vaccine (Vivaxim) available in Australia is licenced for use from age 16 years but the monovalent components are...

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Veröffentlicht in:Journal of travel medicine 2016-02, Vol.23 (2), p.tav023-tav023
Hauptverfasser: Lau, Colleen L., Streeton, Catherine L., David, Michael C., Sly, Peter D., Mills, Deborah J.
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container_end_page tav023
container_issue 2
container_start_page tav023
container_title Journal of travel medicine
container_volume 23
creator Lau, Colleen L.
Streeton, Catherine L.
David, Michael C.
Sly, Peter D.
Mills, Deborah J.
description Background: Combined hepatitis A and typhoid vaccines have been widely used globally and proven to be safe, well tolerated and efficacious in adults. The combined hepatitis A and typhoid vaccine (Vivaxim) available in Australia is licenced for use from age 16 years but the monovalent components are approved for use from age 2 years. Advantages of a single injection have led to widespread ‘off-label’ use of Vivaxim in children. This study aimed to investigate the tolerability of Vivaxim in children aged 2–16 years. Methods: A prospective observational study was conducted at Travel Medicine Alliance clinics across Australia. Children who required vaccination for both hepatitis A and typhoid were offered the option of receiving Vivaxim. Parents were contacted 3 days post-vaccination and asked to respond to a questionnaire on adverse events following immunization (AEFIs). Reactions to Vivaxim were compared with reported reactions to the monovalent vaccines. Results: Our study included 425 children who received Vivaxim, including 189 (44.5%) who received other vaccines on the same day. No serious AEFIs were reported, and 26.8% did not experience any side effects. In children who did not receive other vaccines in the same arm as Vivaxim (n = 325), most common local reactions were sore arm (70.5%), redness (16.0%) and swelling (11.1%). Reports of local AEFIs in our subjects was significantly more common than those reported for the individual monovalent vaccines. In children who did not receive other vaccines on the same day (n = 236), the most common systemic reactions were tiredness/lethargy/malaise (5.9%), headache (4.2%), fever (3.4%) and sore muscles and joints (3.4%). Fever was more common in children aged
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The combined hepatitis A and typhoid vaccine (Vivaxim) available in Australia is licenced for use from age 16 years but the monovalent components are approved for use from age 2 years. Advantages of a single injection have led to widespread ‘off-label’ use of Vivaxim in children. This study aimed to investigate the tolerability of Vivaxim in children aged 2–16 years. Methods: A prospective observational study was conducted at Travel Medicine Alliance clinics across Australia. Children who required vaccination for both hepatitis A and typhoid were offered the option of receiving Vivaxim. Parents were contacted 3 days post-vaccination and asked to respond to a questionnaire on adverse events following immunization (AEFIs). Reactions to Vivaxim were compared with reported reactions to the monovalent vaccines. Results: Our study included 425 children who received Vivaxim, including 189 (44.5%) who received other vaccines on the same day. No serious AEFIs were reported, and 26.8% did not experience any side effects. In children who did not receive other vaccines in the same arm as Vivaxim (n = 325), most common local reactions were sore arm (70.5%), redness (16.0%) and swelling (11.1%). Reports of local AEFIs in our subjects was significantly more common than those reported for the individual monovalent vaccines. In children who did not receive other vaccines on the same day (n = 236), the most common systemic reactions were tiredness/lethargy/malaise (5.9%), headache (4.2%), fever (3.4%) and sore muscles and joints (3.4%). Fever was more common in children aged &lt;6 years. Less than 5% of children reported missing school, sport or other regular activities. Conclusions: Vivaxim was well tolerated in children aged 2–16 years. Parents should be advised about AEFIs to Vivaxim so that they can make informed decisions about vaccination options.</description><identifier>ISSN: 1195-1982</identifier><identifier>EISSN: 1708-8305</identifier><identifier>DOI: 10.1093/jtm/tav023</identifier><identifier>PMID: 26883924</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adolescent ; Child ; Child, Preschool ; Drug Administration Schedule ; Female ; Hepatitis A - prevention &amp; control ; Hepatitis A Vaccines - administration &amp; dosage ; Humans ; Male ; Prospective Studies ; Travel Medicine ; Typhoid Fever - prevention &amp; control ; Typhoid-Paratyphoid Vaccines - administration &amp; dosage ; Vaccines, Combined - administration &amp; dosage ; Vaccines, Combined - adverse effects</subject><ispartof>Journal of travel medicine, 2016-02, Vol.23 (2), p.tav023-tav023</ispartof><rights>International Society of Travel Medicine, 2016. All rights reserved. Published by Oxford University Press. For permissions, please e-mail: journals.permissions@oup.com 2016</rights><rights>International Society of Travel Medicine, 2016. All rights reserved. Published by Oxford University Press. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-f8c6ca14c59c83a13a471be8e271505734177010598d0aa39a33e0fcf53e31ca3</citedby><cites>FETCH-LOGICAL-c353t-f8c6ca14c59c83a13a471be8e271505734177010598d0aa39a33e0fcf53e31ca3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26883924$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lau, Colleen L.</creatorcontrib><creatorcontrib>Streeton, Catherine L.</creatorcontrib><creatorcontrib>David, Michael C.</creatorcontrib><creatorcontrib>Sly, Peter D.</creatorcontrib><creatorcontrib>Mills, Deborah J.</creatorcontrib><title>The tolerability of a combined hepatitis A and typhoid vaccine in children aged 2–16 years: an observational study</title><title>Journal of travel medicine</title><addtitle>J Travel Med</addtitle><description>Background: Combined hepatitis A and typhoid vaccines have been widely used globally and proven to be safe, well tolerated and efficacious in adults. The combined hepatitis A and typhoid vaccine (Vivaxim) available in Australia is licenced for use from age 16 years but the monovalent components are approved for use from age 2 years. Advantages of a single injection have led to widespread ‘off-label’ use of Vivaxim in children. This study aimed to investigate the tolerability of Vivaxim in children aged 2–16 years. Methods: A prospective observational study was conducted at Travel Medicine Alliance clinics across Australia. Children who required vaccination for both hepatitis A and typhoid were offered the option of receiving Vivaxim. Parents were contacted 3 days post-vaccination and asked to respond to a questionnaire on adverse events following immunization (AEFIs). Reactions to Vivaxim were compared with reported reactions to the monovalent vaccines. Results: Our study included 425 children who received Vivaxim, including 189 (44.5%) who received other vaccines on the same day. No serious AEFIs were reported, and 26.8% did not experience any side effects. In children who did not receive other vaccines in the same arm as Vivaxim (n = 325), most common local reactions were sore arm (70.5%), redness (16.0%) and swelling (11.1%). Reports of local AEFIs in our subjects was significantly more common than those reported for the individual monovalent vaccines. In children who did not receive other vaccines on the same day (n = 236), the most common systemic reactions were tiredness/lethargy/malaise (5.9%), headache (4.2%), fever (3.4%) and sore muscles and joints (3.4%). Fever was more common in children aged &lt;6 years. Less than 5% of children reported missing school, sport or other regular activities. Conclusions: Vivaxim was well tolerated in children aged 2–16 years. Parents should be advised about AEFIs to Vivaxim so that they can make informed decisions about vaccination options.</description><subject>Adolescent</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Hepatitis A - prevention &amp; control</subject><subject>Hepatitis A Vaccines - administration &amp; dosage</subject><subject>Humans</subject><subject>Male</subject><subject>Prospective Studies</subject><subject>Travel Medicine</subject><subject>Typhoid Fever - prevention &amp; control</subject><subject>Typhoid-Paratyphoid Vaccines - administration &amp; dosage</subject><subject>Vaccines, Combined - administration &amp; dosage</subject><subject>Vaccines, Combined - adverse effects</subject><issn>1195-1982</issn><issn>1708-8305</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kM1q3DAURkVJaKaTbvoAQZtAKbijn5EtZzeE_kEgm8naXMvXHQXbciR5wLu8Q94wTxIVJ11mde_ifGdxCPnC2XfOSrm5j_0mwpEJ-YGseMF0piVTJ-nnpcp4qcUZ-RTCPWNMaCE-kjORay1LsV2RuD8gja5DD7XtbJypaylQ4_raDtjQA44QbbSB7igMDY3zeHC2oUcwJgHUDtQcbNd4HCj8TQPx_PjEczoj-HCVJtTVAf0xSdwAHQ1xauZzctpCF_Dz612Tu58_9te_s5vbX3-udzeZkUrGrNUmN8C3RpVGS-AStgWvUaMouGKqkFteFIwzVeqGAcgSpETWmlZJlNyAXJOvi3f07mHCEKveBoNdBwO6KVS8yHOR56rgCf22oMa7EDy21ehtD36uOKv-Va5S5WqpnOCLV-9U99j8R9-yJuByAdw0vid6AVYnhqE</recordid><startdate>201602</startdate><enddate>201602</enddate><creator>Lau, Colleen L.</creator><creator>Streeton, Catherine L.</creator><creator>David, Michael C.</creator><creator>Sly, Peter D.</creator><creator>Mills, Deborah J.</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201602</creationdate><title>The tolerability of a combined hepatitis A and typhoid vaccine in children aged 2–16 years: an observational study</title><author>Lau, Colleen L. ; Streeton, Catherine L. ; David, Michael C. ; Sly, Peter D. ; Mills, Deborah J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-f8c6ca14c59c83a13a471be8e271505734177010598d0aa39a33e0fcf53e31ca3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adolescent</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Hepatitis A - prevention &amp; control</topic><topic>Hepatitis A Vaccines - administration &amp; dosage</topic><topic>Humans</topic><topic>Male</topic><topic>Prospective Studies</topic><topic>Travel Medicine</topic><topic>Typhoid Fever - prevention &amp; control</topic><topic>Typhoid-Paratyphoid Vaccines - administration &amp; dosage</topic><topic>Vaccines, Combined - administration &amp; dosage</topic><topic>Vaccines, Combined - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lau, Colleen L.</creatorcontrib><creatorcontrib>Streeton, Catherine L.</creatorcontrib><creatorcontrib>David, Michael C.</creatorcontrib><creatorcontrib>Sly, Peter D.</creatorcontrib><creatorcontrib>Mills, Deborah J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of travel medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lau, Colleen L.</au><au>Streeton, Catherine L.</au><au>David, Michael C.</au><au>Sly, Peter D.</au><au>Mills, Deborah J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The tolerability of a combined hepatitis A and typhoid vaccine in children aged 2–16 years: an observational study</atitle><jtitle>Journal of travel medicine</jtitle><addtitle>J Travel Med</addtitle><date>2016-02</date><risdate>2016</risdate><volume>23</volume><issue>2</issue><spage>tav023</spage><epage>tav023</epage><pages>tav023-tav023</pages><issn>1195-1982</issn><eissn>1708-8305</eissn><abstract>Background: Combined hepatitis A and typhoid vaccines have been widely used globally and proven to be safe, well tolerated and efficacious in adults. The combined hepatitis A and typhoid vaccine (Vivaxim) available in Australia is licenced for use from age 16 years but the monovalent components are approved for use from age 2 years. Advantages of a single injection have led to widespread ‘off-label’ use of Vivaxim in children. This study aimed to investigate the tolerability of Vivaxim in children aged 2–16 years. Methods: A prospective observational study was conducted at Travel Medicine Alliance clinics across Australia. Children who required vaccination for both hepatitis A and typhoid were offered the option of receiving Vivaxim. Parents were contacted 3 days post-vaccination and asked to respond to a questionnaire on adverse events following immunization (AEFIs). Reactions to Vivaxim were compared with reported reactions to the monovalent vaccines. Results: Our study included 425 children who received Vivaxim, including 189 (44.5%) who received other vaccines on the same day. No serious AEFIs were reported, and 26.8% did not experience any side effects. In children who did not receive other vaccines in the same arm as Vivaxim (n = 325), most common local reactions were sore arm (70.5%), redness (16.0%) and swelling (11.1%). Reports of local AEFIs in our subjects was significantly more common than those reported for the individual monovalent vaccines. In children who did not receive other vaccines on the same day (n = 236), the most common systemic reactions were tiredness/lethargy/malaise (5.9%), headache (4.2%), fever (3.4%) and sore muscles and joints (3.4%). Fever was more common in children aged &lt;6 years. Less than 5% of children reported missing school, sport or other regular activities. Conclusions: Vivaxim was well tolerated in children aged 2–16 years. Parents should be advised about AEFIs to Vivaxim so that they can make informed decisions about vaccination options.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>26883924</pmid><doi>10.1093/jtm/tav023</doi><oa>free_for_read</oa></addata></record>
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subjects Adolescent
Child
Child, Preschool
Drug Administration Schedule
Female
Hepatitis A - prevention & control
Hepatitis A Vaccines - administration & dosage
Humans
Male
Prospective Studies
Travel Medicine
Typhoid Fever - prevention & control
Typhoid-Paratyphoid Vaccines - administration & dosage
Vaccines, Combined - administration & dosage
Vaccines, Combined - adverse effects
title The tolerability of a combined hepatitis A and typhoid vaccine in children aged 2–16 years: an observational study
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