Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age
BACKGROUND:Strains of 2 distinct influenza B lineages (Victoria and Yamagata) have cocirculated in the United States for over a decade, but trivalent influenza vaccines (TIVs) contain only 1 B-lineage strain. Each season, some or most influenza B disease is caused by the B lineage not represented in...
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| Veröffentlicht in: | The Pediatric infectious disease journal 2014-06, Vol.33 (6), p.630-636 |
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| creator | Greenberg, David P Robertson, Corwin A Landolfi, Victoria A Bhaumik, Amitabha Senders, Shelly D Decker, Michael D |
| description | BACKGROUND:Strains of 2 distinct influenza B lineages (Victoria and Yamagata) have cocirculated in the United States for over a decade, but trivalent influenza vaccines (TIVs) contain only 1 B-lineage strain. Each season, some or most influenza B disease is caused by the B lineage not represented in that season’s TIV. Quadrivalent influenza vaccines (QIVs) containing a strain from each B lineage should resolve this problem.
METHODS:This was a Phase III, randomized, multicenter trial in the United States among children 6 months to |
| doi_str_mv | 10.1097/INF.0000000000000254 |
| format | Article |
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METHODS:This was a Phase III, randomized, multicenter trial in the United States among children 6 months to <9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared with inactivated control TIVs containing opposite B-lineage strains. Participants were randomized at a ratio of approximately 4:1:1 to receive QIV, TIV containing a Victoria-lineage B strain or TIV containing a Yamagata-lineage B strain. Sera were collected pre- and 28-days post-final vaccination and safety was assessed for 6 months after the last injection.
RESULTS:A total of 4363 participants were enrolled. QIV induced noninferior antibody responses to all A strains and corresponding B strains compared with the control TIVs and superior antibody responses to the noncorresponding B strain in each TIV. Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups.
CONCLUSIONS:This study demonstrated that QIV is safe and immunogenic among children 6 months to <9 years of age. These findings, along with data from 2 other studies of this QIV in adults, suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages.</description><identifier>ISSN: 0891-3668</identifier><identifier>EISSN: 1532-0987</identifier><identifier>DOI: 10.1097/INF.0000000000000254</identifier><identifier>PMID: 24445833</identifier><identifier>CODEN: PIDJEV</identifier><language>eng</language><publisher>Hagerstown, MD: by Lippincott Williams & Wilkins, Inc</publisher><subject>Antibodies, Viral - blood ; Biological and medical sciences ; Child ; Child, Preschool ; Female ; Human viral diseases ; Humans ; Infant ; Infectious diseases ; Influenza Vaccines - administration & dosage ; Influenza Vaccines - adverse effects ; Influenza Vaccines - immunology ; Influenza, Human - epidemiology ; Influenza, Human - immunology ; Influenza, Human - prevention & control ; Male ; Medical sciences ; Orthomyxoviridae - immunology ; United States - epidemiology ; Vaccines, Inactivated - administration & dosage ; Vaccines, Inactivated - adverse effects ; Vaccines, Inactivated - immunology ; Viral diseases ; Viral diseases of the respiratory system and ent viral diseases</subject><ispartof>The Pediatric infectious disease journal, 2014-06, Vol.33 (6), p.630-636</ispartof><rights>2014 by Lippincott Williams & Wilkins, Inc.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4324-91fb0f3586fa31e919b5bf68670d9b5057b37b5c62ac325e3e600458731dcaba3</citedby><cites>FETCH-LOGICAL-c4324-91fb0f3586fa31e919b5bf68670d9b5057b37b5c62ac325e3e600458731dcaba3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28604202$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24445833$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Greenberg, David P</creatorcontrib><creatorcontrib>Robertson, Corwin A</creatorcontrib><creatorcontrib>Landolfi, Victoria A</creatorcontrib><creatorcontrib>Bhaumik, Amitabha</creatorcontrib><creatorcontrib>Senders, Shelly D</creatorcontrib><creatorcontrib>Decker, Michael D</creatorcontrib><title>Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age</title><title>The Pediatric infectious disease journal</title><addtitle>Pediatr Infect Dis J</addtitle><description>BACKGROUND:Strains of 2 distinct influenza B lineages (Victoria and Yamagata) have cocirculated in the United States for over a decade, but trivalent influenza vaccines (TIVs) contain only 1 B-lineage strain. Each season, some or most influenza B disease is caused by the B lineage not represented in that season’s TIV. Quadrivalent influenza vaccines (QIVs) containing a strain from each B lineage should resolve this problem.
METHODS:This was a Phase III, randomized, multicenter trial in the United States among children 6 months to <9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared with inactivated control TIVs containing opposite B-lineage strains. Participants were randomized at a ratio of approximately 4:1:1 to receive QIV, TIV containing a Victoria-lineage B strain or TIV containing a Yamagata-lineage B strain. Sera were collected pre- and 28-days post-final vaccination and safety was assessed for 6 months after the last injection.
RESULTS:A total of 4363 participants were enrolled. QIV induced noninferior antibody responses to all A strains and corresponding B strains compared with the control TIVs and superior antibody responses to the noncorresponding B strain in each TIV. Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups.
CONCLUSIONS:This study demonstrated that QIV is safe and immunogenic among children 6 months to <9 years of age. These findings, along with data from 2 other studies of this QIV in adults, suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages.</description><subject>Antibodies, Viral - blood</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Female</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infant</subject><subject>Infectious diseases</subject><subject>Influenza Vaccines - administration & dosage</subject><subject>Influenza Vaccines - adverse effects</subject><subject>Influenza Vaccines - immunology</subject><subject>Influenza, Human - epidemiology</subject><subject>Influenza, Human - immunology</subject><subject>Influenza, Human - prevention & control</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Orthomyxoviridae - immunology</subject><subject>United States - epidemiology</subject><subject>Vaccines, Inactivated - administration & dosage</subject><subject>Vaccines, Inactivated - adverse effects</subject><subject>Vaccines, Inactivated - immunology</subject><subject>Viral diseases</subject><subject>Viral diseases of the respiratory system and ent viral diseases</subject><issn>0891-3668</issn><issn>1532-0987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEtv1DAQxy0EokvhGyDkCxKXFDt-xDlWK9quVFohHhKnaOKMNwHHae2kVfn0uNqlIA6dy4xmfvP6E_KasyPO6ur95uLkiP1rpZJPyIorURasNtVTsmKm5oXQ2hyQFyn9yIyQnD0nB6WUUhkhVuTmMzic7yiEjm7GcQnTFsNgh5yaXM7STQA7DzcwY0c_LdDFHHsMcy44v2D4BfQbWDsEpEOg637wXcRANf04hblPdO7jtGx7auh3hJjupx5v8SV55sAnfLX3h-TryYcv67Pi_PJ0sz4-L6wUpSxq7lrmhDLageBY87pVrdNGV6zLIVNVK6pWWV2CFaVCgZqx_FkleGehBXFI3u3mXsXpesE0N-OQLHoPAaclNVyVqtLCyDqjcofaOKUU0TVXcRgh3jWcNfeKN1nx5n_Fc9ub_YalHbF7aPojcQbe7gFIFryLEOyQ_nJGM1myMnNmx91OfsaYfvrlFmPTI_i5f_yG3zfCmTU</recordid><startdate>201406</startdate><enddate>201406</enddate><creator>Greenberg, David P</creator><creator>Robertson, Corwin A</creator><creator>Landolfi, Victoria A</creator><creator>Bhaumik, Amitabha</creator><creator>Senders, Shelly D</creator><creator>Decker, Michael D</creator><general>by Lippincott Williams & Wilkins, Inc</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><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>201406</creationdate><title>Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age</title><author>Greenberg, David P ; Robertson, Corwin A ; Landolfi, Victoria A ; Bhaumik, Amitabha ; Senders, Shelly D ; Decker, Michael D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4324-91fb0f3586fa31e919b5bf68670d9b5057b37b5c62ac325e3e600458731dcaba3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Antibodies, Viral - blood</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Female</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infant</topic><topic>Infectious diseases</topic><topic>Influenza Vaccines - administration & dosage</topic><topic>Influenza Vaccines - adverse effects</topic><topic>Influenza Vaccines - immunology</topic><topic>Influenza, Human - epidemiology</topic><topic>Influenza, Human - immunology</topic><topic>Influenza, Human - prevention & control</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Orthomyxoviridae - immunology</topic><topic>United States - epidemiology</topic><topic>Vaccines, Inactivated - administration & dosage</topic><topic>Vaccines, Inactivated - adverse effects</topic><topic>Vaccines, Inactivated - immunology</topic><topic>Viral diseases</topic><topic>Viral diseases of the respiratory system and ent viral diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Greenberg, David P</creatorcontrib><creatorcontrib>Robertson, Corwin A</creatorcontrib><creatorcontrib>Landolfi, Victoria A</creatorcontrib><creatorcontrib>Bhaumik, Amitabha</creatorcontrib><creatorcontrib>Senders, Shelly D</creatorcontrib><creatorcontrib>Decker, Michael D</creatorcontrib><collection>Pascal-Francis</collection><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>The Pediatric infectious disease journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Greenberg, David P</au><au>Robertson, Corwin A</au><au>Landolfi, Victoria A</au><au>Bhaumik, Amitabha</au><au>Senders, Shelly D</au><au>Decker, Michael D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age</atitle><jtitle>The Pediatric infectious disease journal</jtitle><addtitle>Pediatr Infect Dis J</addtitle><date>2014-06</date><risdate>2014</risdate><volume>33</volume><issue>6</issue><spage>630</spage><epage>636</epage><pages>630-636</pages><issn>0891-3668</issn><eissn>1532-0987</eissn><coden>PIDJEV</coden><abstract>BACKGROUND:Strains of 2 distinct influenza B lineages (Victoria and Yamagata) have cocirculated in the United States for over a decade, but trivalent influenza vaccines (TIVs) contain only 1 B-lineage strain. Each season, some or most influenza B disease is caused by the B lineage not represented in that season’s TIV. Quadrivalent influenza vaccines (QIVs) containing a strain from each B lineage should resolve this problem.
METHODS:This was a Phase III, randomized, multicenter trial in the United States among children 6 months to <9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared with inactivated control TIVs containing opposite B-lineage strains. Participants were randomized at a ratio of approximately 4:1:1 to receive QIV, TIV containing a Victoria-lineage B strain or TIV containing a Yamagata-lineage B strain. Sera were collected pre- and 28-days post-final vaccination and safety was assessed for 6 months after the last injection.
RESULTS:A total of 4363 participants were enrolled. QIV induced noninferior antibody responses to all A strains and corresponding B strains compared with the control TIVs and superior antibody responses to the noncorresponding B strain in each TIV. Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups.
CONCLUSIONS:This study demonstrated that QIV is safe and immunogenic among children 6 months to <9 years of age. These findings, along with data from 2 other studies of this QIV in adults, suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages.</abstract><cop>Hagerstown, MD</cop><pub>by Lippincott Williams & Wilkins, Inc</pub><pmid>24445833</pmid><doi>10.1097/INF.0000000000000254</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Pediatric infectious disease journal, 2014-06, Vol.33 (6), p.630-636 |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Antibodies, Viral - blood Biological and medical sciences Child Child, Preschool Female Human viral diseases Humans Infant Infectious diseases Influenza Vaccines - administration & dosage Influenza Vaccines - adverse effects Influenza Vaccines - immunology Influenza, Human - epidemiology Influenza, Human - immunology Influenza, Human - prevention & control Male Medical sciences Orthomyxoviridae - immunology United States - epidemiology Vaccines, Inactivated - administration & dosage Vaccines, Inactivated - adverse effects Vaccines, Inactivated - immunology Viral diseases Viral diseases of the respiratory system and ent viral diseases |
| title | Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age |
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