Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a...
Gespeichert in:
| Veröffentlicht in: | Pediatrics (Evanston) 2016-02, Vol.137 (2), p.e20152603-e20152603 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | e20152603 |
|---|---|
| container_issue | 2 |
| container_start_page | e20152603 |
| container_title | Pediatrics (Evanston) |
| container_volume | 137 |
| creator | Libster, Romina McNeal, Monica Walter, Emmanuel B Shane, Andi L Winokur, Patricia Cress, Gretchen Berry, Andrea A Kotloff, Karen L Sarpong, Kwabena Turley, Christine B Harrison, Christopher J Pahud, Barbara A Marbin, Jyothi Dunn, John El-Khorazaty, Jill Barrett, Jill Edwards, Kathryn M |
| description | Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone.
Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups.
Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated.
Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone. |
| doi_str_mv | 10.1542/peds.2015-2603 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4732359</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A445481514</galeid><sourcerecordid>A445481514</sourcerecordid><originalsourceid>FETCH-LOGICAL-c555t-fe223ea8ac1e9ecc12250712199624de14175a30e76148aacc32a943933a979a3</originalsourceid><addsrcrecordid>eNqNkc1rFTEUxYNY7Gt161IG3LiZ13xOMhuhPLQWCgWfug3XzJ3XlEzynMwU-9-b4dWiXXUVuPnl3JxzCHnL6Jopyc_22OU1p0zVvKHiBVkx2ppacq1ekhWlgtWSUnVMTnK-pZRKpfkrcswbw4WSdEU2W-hxuq8gdtXlMMwx7TB658so9dUWf80YJw-h-pomuPPjnKsf4JyPWG3dDXZzwPyaHPUQMr55OE_J98-fvm2-1FfXF5eb86vaKaWmukfOBYIBx7BF5xjnimrGWds2XHbIJNMKBEXdMGmgbBEcWilaIaDVLYhT8vGgu59_Dti58rMRgt2PfoDx3ibw9v-b6G_sLt1ZqUWx2xaBDw8CYyrG8mQHnx2GABHTnC3TWpiSixTPQBvDmoZKXtD3T9DbNI-xJLFQShkj6ELVB2oHAa2PLsUJf08uhYA7tCWozbU9l1JJwxSThV8feDemnEfsH30yapfq7VK9Xaq3S_Xlwbt_03nE_3Yt_gDZJqhl</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1765588302</pqid></control><display><type>article</type><title>Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Libster, Romina ; McNeal, Monica ; Walter, Emmanuel B ; Shane, Andi L ; Winokur, Patricia ; Cress, Gretchen ; Berry, Andrea A ; Kotloff, Karen L ; Sarpong, Kwabena ; Turley, Christine B ; Harrison, Christopher J ; Pahud, Barbara A ; Marbin, Jyothi ; Dunn, John ; El-Khorazaty, Jill ; Barrett, Jill ; Edwards, Kathryn M</creator><creatorcontrib>Libster, Romina ; McNeal, Monica ; Walter, Emmanuel B ; Shane, Andi L ; Winokur, Patricia ; Cress, Gretchen ; Berry, Andrea A ; Kotloff, Karen L ; Sarpong, Kwabena ; Turley, Christine B ; Harrison, Christopher J ; Pahud, Barbara A ; Marbin, Jyothi ; Dunn, John ; El-Khorazaty, Jill ; Barrett, Jill ; Edwards, Kathryn M ; VTEU Rotavirus Vaccine Study Work Group ; for the VTEU Rotavirus Vaccine Study Work Group</creatorcontrib><description>Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone.
Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups.
Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated.
Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.</description><identifier>ISSN: 0031-4005</identifier><identifier>EISSN: 1098-4275</identifier><identifier>DOI: 10.1542/peds.2015-2603</identifier><identifier>PMID: 26823540</identifier><identifier>CODEN: PEDIAU</identifier><language>eng</language><publisher>United States: American Academy of Pediatrics</publisher><subject>Antibodies, Viral - blood ; Biomarkers - blood ; Care and treatment ; Children & youth ; Clinical trials ; Enzyme-Linked Immunosorbent Assay ; Female ; Health aspects ; Humans ; Immune system ; Immunization Schedule ; Infant ; Infants ; Male ; Patient Safety ; Pediatrics ; Rotavirus ; Rotavirus - immunology ; Rotavirus infections ; Rotavirus Vaccines - adverse effects ; Rotavirus Vaccines - immunology ; Vaccines ; Viruses</subject><ispartof>Pediatrics (Evanston), 2016-02, Vol.137 (2), p.e20152603-e20152603</ispartof><rights>Copyright © 2016 by the American Academy of Pediatrics.</rights><rights>Copyright American Academy of Pediatrics Feb 2016</rights><rights>Copyright © 2016 by the American Academy of Pediatrics 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c555t-fe223ea8ac1e9ecc12250712199624de14175a30e76148aacc32a943933a979a3</citedby><cites>FETCH-LOGICAL-c555t-fe223ea8ac1e9ecc12250712199624de14175a30e76148aacc32a943933a979a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26823540$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Libster, Romina</creatorcontrib><creatorcontrib>McNeal, Monica</creatorcontrib><creatorcontrib>Walter, Emmanuel B</creatorcontrib><creatorcontrib>Shane, Andi L</creatorcontrib><creatorcontrib>Winokur, Patricia</creatorcontrib><creatorcontrib>Cress, Gretchen</creatorcontrib><creatorcontrib>Berry, Andrea A</creatorcontrib><creatorcontrib>Kotloff, Karen L</creatorcontrib><creatorcontrib>Sarpong, Kwabena</creatorcontrib><creatorcontrib>Turley, Christine B</creatorcontrib><creatorcontrib>Harrison, Christopher J</creatorcontrib><creatorcontrib>Pahud, Barbara A</creatorcontrib><creatorcontrib>Marbin, Jyothi</creatorcontrib><creatorcontrib>Dunn, John</creatorcontrib><creatorcontrib>El-Khorazaty, Jill</creatorcontrib><creatorcontrib>Barrett, Jill</creatorcontrib><creatorcontrib>Edwards, Kathryn M</creatorcontrib><creatorcontrib>VTEU Rotavirus Vaccine Study Work Group</creatorcontrib><creatorcontrib>for the VTEU Rotavirus Vaccine Study Work Group</creatorcontrib><title>Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules</title><title>Pediatrics (Evanston)</title><addtitle>Pediatrics</addtitle><description>Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone.
Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups.
Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated.
Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.</description><subject>Antibodies, Viral - blood</subject><subject>Biomarkers - blood</subject><subject>Care and treatment</subject><subject>Children & youth</subject><subject>Clinical trials</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Female</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Immune system</subject><subject>Immunization Schedule</subject><subject>Infant</subject><subject>Infants</subject><subject>Male</subject><subject>Patient Safety</subject><subject>Pediatrics</subject><subject>Rotavirus</subject><subject>Rotavirus - immunology</subject><subject>Rotavirus infections</subject><subject>Rotavirus Vaccines - adverse effects</subject><subject>Rotavirus Vaccines - immunology</subject><subject>Vaccines</subject><subject>Viruses</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkc1rFTEUxYNY7Gt161IG3LiZ13xOMhuhPLQWCgWfug3XzJ3XlEzynMwU-9-b4dWiXXUVuPnl3JxzCHnL6Jopyc_22OU1p0zVvKHiBVkx2ppacq1ekhWlgtWSUnVMTnK-pZRKpfkrcswbw4WSdEU2W-hxuq8gdtXlMMwx7TB658so9dUWf80YJw-h-pomuPPjnKsf4JyPWG3dDXZzwPyaHPUQMr55OE_J98-fvm2-1FfXF5eb86vaKaWmukfOBYIBx7BF5xjnimrGWds2XHbIJNMKBEXdMGmgbBEcWilaIaDVLYhT8vGgu59_Dti58rMRgt2PfoDx3ibw9v-b6G_sLt1ZqUWx2xaBDw8CYyrG8mQHnx2GABHTnC3TWpiSixTPQBvDmoZKXtD3T9DbNI-xJLFQShkj6ELVB2oHAa2PLsUJf08uhYA7tCWozbU9l1JJwxSThV8feDemnEfsH30yapfq7VK9Xaq3S_Xlwbt_03nE_3Yt_gDZJqhl</recordid><startdate>201602</startdate><enddate>201602</enddate><creator>Libster, Romina</creator><creator>McNeal, Monica</creator><creator>Walter, Emmanuel B</creator><creator>Shane, Andi L</creator><creator>Winokur, Patricia</creator><creator>Cress, Gretchen</creator><creator>Berry, Andrea A</creator><creator>Kotloff, Karen L</creator><creator>Sarpong, Kwabena</creator><creator>Turley, Christine B</creator><creator>Harrison, Christopher J</creator><creator>Pahud, Barbara A</creator><creator>Marbin, Jyothi</creator><creator>Dunn, John</creator><creator>El-Khorazaty, Jill</creator><creator>Barrett, Jill</creator><creator>Edwards, Kathryn M</creator><general>American Academy of Pediatrics</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>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>U9A</scope><scope>7X8</scope><scope>7T5</scope><scope>5PM</scope></search><sort><creationdate>201602</creationdate><title>Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules</title><author>Libster, Romina ; McNeal, Monica ; Walter, Emmanuel B ; Shane, Andi L ; Winokur, Patricia ; Cress, Gretchen ; Berry, Andrea A ; Kotloff, Karen L ; Sarpong, Kwabena ; Turley, Christine B ; Harrison, Christopher J ; Pahud, Barbara A ; Marbin, Jyothi ; Dunn, John ; El-Khorazaty, Jill ; Barrett, Jill ; Edwards, Kathryn M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c555t-fe223ea8ac1e9ecc12250712199624de14175a30e76148aacc32a943933a979a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Antibodies, Viral - blood</topic><topic>Biomarkers - blood</topic><topic>Care and treatment</topic><topic>Children & youth</topic><topic>Clinical trials</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Female</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Immune system</topic><topic>Immunization Schedule</topic><topic>Infant</topic><topic>Infants</topic><topic>Male</topic><topic>Patient Safety</topic><topic>Pediatrics</topic><topic>Rotavirus</topic><topic>Rotavirus - immunology</topic><topic>Rotavirus infections</topic><topic>Rotavirus Vaccines - adverse effects</topic><topic>Rotavirus Vaccines - immunology</topic><topic>Vaccines</topic><topic>Viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Libster, Romina</creatorcontrib><creatorcontrib>McNeal, Monica</creatorcontrib><creatorcontrib>Walter, Emmanuel B</creatorcontrib><creatorcontrib>Shane, Andi L</creatorcontrib><creatorcontrib>Winokur, Patricia</creatorcontrib><creatorcontrib>Cress, Gretchen</creatorcontrib><creatorcontrib>Berry, Andrea A</creatorcontrib><creatorcontrib>Kotloff, Karen L</creatorcontrib><creatorcontrib>Sarpong, Kwabena</creatorcontrib><creatorcontrib>Turley, Christine B</creatorcontrib><creatorcontrib>Harrison, Christopher J</creatorcontrib><creatorcontrib>Pahud, Barbara A</creatorcontrib><creatorcontrib>Marbin, Jyothi</creatorcontrib><creatorcontrib>Dunn, John</creatorcontrib><creatorcontrib>El-Khorazaty, Jill</creatorcontrib><creatorcontrib>Barrett, Jill</creatorcontrib><creatorcontrib>Edwards, Kathryn M</creatorcontrib><creatorcontrib>VTEU Rotavirus Vaccine Study Work Group</creatorcontrib><creatorcontrib>for the VTEU Rotavirus Vaccine Study Work Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Physical Education Index</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pediatrics (Evanston)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Libster, Romina</au><au>McNeal, Monica</au><au>Walter, Emmanuel B</au><au>Shane, Andi L</au><au>Winokur, Patricia</au><au>Cress, Gretchen</au><au>Berry, Andrea A</au><au>Kotloff, Karen L</au><au>Sarpong, Kwabena</au><au>Turley, Christine B</au><au>Harrison, Christopher J</au><au>Pahud, Barbara A</au><au>Marbin, Jyothi</au><au>Dunn, John</au><au>El-Khorazaty, Jill</au><au>Barrett, Jill</au><au>Edwards, Kathryn M</au><aucorp>VTEU Rotavirus Vaccine Study Work Group</aucorp><aucorp>for the VTEU Rotavirus Vaccine Study Work Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules</atitle><jtitle>Pediatrics (Evanston)</jtitle><addtitle>Pediatrics</addtitle><date>2016-02</date><risdate>2016</risdate><volume>137</volume><issue>2</issue><spage>e20152603</spage><epage>e20152603</epage><pages>e20152603-e20152603</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><coden>PEDIAU</coden><abstract>Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone.
Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups.
Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated.
Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.</abstract><cop>United States</cop><pub>American Academy of Pediatrics</pub><pmid>26823540</pmid><doi>10.1542/peds.2015-2603</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0031-4005 |
| ispartof | Pediatrics (Evanston), 2016-02, Vol.137 (2), p.e20152603-e20152603 |
| issn | 0031-4005 1098-4275 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4732359 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Antibodies, Viral - blood Biomarkers - blood Care and treatment Children & youth Clinical trials Enzyme-Linked Immunosorbent Assay Female Health aspects Humans Immune system Immunization Schedule Infant Infants Male Patient Safety Pediatrics Rotavirus Rotavirus - immunology Rotavirus infections Rotavirus Vaccines - adverse effects Rotavirus Vaccines - immunology Vaccines Viruses |
| title | Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-09T01%3A47%3A51IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Safety%20and%20Immunogenicity%20of%20Sequential%20Rotavirus%20Vaccine%20Schedules&rft.jtitle=Pediatrics%20(Evanston)&rft.au=Libster,%20Romina&rft.aucorp=VTEU%20Rotavirus%20Vaccine%20Study%20Work%20Group&rft.date=2016-02&rft.volume=137&rft.issue=2&rft.spage=e20152603&rft.epage=e20152603&rft.pages=e20152603-e20152603&rft.issn=0031-4005&rft.eissn=1098-4275&rft.coden=PEDIAU&rft_id=info:doi/10.1542/peds.2015-2603&rft_dat=%3Cgale_pubme%3EA445481514%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1765588302&rft_id=info:pmid/26823540&rft_galeid=A445481514&rfr_iscdi=true |