Rapid safety assessment of a seasonal intradermal trivalent influenza vaccine.
Identifieur interne : 000014 ( Main/Exploration ); précédent : 000013; suivant : 000015Rapid safety assessment of a seasonal intradermal trivalent influenza vaccine.
Auteurs : Marc Demeulemeester [Belgique] ; Nathalie Lavis [France] ; Yohan Balthazar [Belgique] ; Patrice Lechien [Belgique] ; Stéphane Heijmans [Belgique]Source :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2017.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Belgique, Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Facteurs temps, Femelle, Grippe humaine (), Humains, Injections intradermiques, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Volontaires sains.
- MESH :
- administration et posologie : Vaccins antigrippaux.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Vaccins antigrippaux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adolescent, Adulte, Adulte d'âge moyen, Belgique, Facteurs temps, Femelle, Grippe humaine, Humains, Injections intradermiques, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Volontaires sains.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Belgium, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Healthy Volunteers, Humans, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (prevention & control), Injections, Intradermal, Male, Middle Aged, Time Factors, Young Adult.
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Aged, Aged, 80 and over, Belgium, Female, Healthy Volunteers, Humans, Injections, Intradermal, Male, Middle Aged, Time Factors, Young Adult.
Abstract
Seasonal influenza vaccine formulations must be updated annually to correspond to the influenza viruses in circulation. This was an uncontrolled, open-label, multi-center phase IV study conducted in Belgium to comply with interim European Medicines Agency (EMA) guidelines for rapidly evaluating the safety of newly formulated seasonal influenza vaccines. Adult volunteers received one dose of the 2014-2015 Northern Hemisphere formulation of licensed intradermal trivalent influenza vaccine at either the standard dose (9µg hemagglutinin/strain for 18-59 year-olds) or the high dose (15µg hemagglutinin/strain for ≥ 60 year-olds). Vaccinees recorded their solicited reactions and unsolicited adverse events for 7 d after vaccination. Solicited reaction frequencies were compared to historical reference values obtained from previous clinical trials to determine if the new formulations were excessively reactogenic or allergenic. A total of 210 participants (105 per age group) were included and vaccinated in October 2014. In both groups, pain, erythema, and pruritus were the most common solicited injection site reactions, and headache and myalgia were the most common solicited systemic reactions. Although the frequencies of shivering in 18-59 year-olds and malaise in ≥ 60 year-olds were higher than historical reference values, they were not considered indicative of excessive reactogenicity because almost all of these reactions were mild. The study design was endorsed by the EMA and permitted the reactogenicity of both vaccine formulations to be assessed within one month by collecting adverse events for 7 d. Both formulations exhibited acceptable safety profiles although this should be confirmed through forthcoming enhanced post-marketing safety surveillance systems.
DOI: 10.1080/21645515.2016.1253644
PubMed: 27960593
Affiliations:
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Private practitioner , Linkebeek , Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>e Private practitioner , Linkebeek </wicri:regionArea><wicri:noRegion>Linkebeek </wicri:noRegion></affiliation></author></analytic><series><title level="j">Human vaccines & immunotherapeutics</title><idno type="eISSN">2164-554X</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Belgium</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Female</term><term>Healthy Volunteers</term><term>Humans</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza, Human (prevention & 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type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Belgium</term><term>Female</term><term>Healthy Volunteers</term><term>Humans</term><term>Injections, Intradermal</term><term>Male</term><term>Middle Aged</term><term>Time Factors</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Belgique</term><term>Facteurs temps</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Injections intradermiques</term><term>Jeune adulte</term><term>Mâle</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Volontaires sains</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Seasonal influenza vaccine formulations must be updated annually to correspond to the influenza viruses in circulation. This was an uncontrolled, open-label, multi-center phase IV study conducted in Belgium to comply with interim European Medicines Agency (EMA) guidelines for rapidly evaluating the safety of newly formulated seasonal influenza vaccines. Adult volunteers received one dose of the 2014-2015 Northern Hemisphere formulation of licensed intradermal trivalent influenza vaccine at either the standard dose (9µg hemagglutinin/strain for 18-59 year-olds) or the high dose (15µg hemagglutinin/strain for ≥ 60 year-olds). Vaccinees recorded their solicited reactions and unsolicited adverse events for 7 d after vaccination. Solicited reaction frequencies were compared to historical reference values obtained from previous clinical trials to determine if the new formulations were excessively reactogenic or allergenic. A total of 210 participants (105 per age group) were included and vaccinated in October 2014. In both groups, pain, erythema, and pruritus were the most common solicited injection site reactions, and headache and myalgia were the most common solicited systemic reactions. Although the frequencies of shivering in 18-59 year-olds and malaise in ≥ 60 year-olds were higher than historical reference values, they were not considered indicative of excessive reactogenicity because almost all of these reactions were mild. The study design was endorsed by the EMA and permitted the reactogenicity of both vaccine formulations to be assessed within one month by collecting adverse events for 7 d. Both formulations exhibited acceptable safety profiles although this should be confirmed through forthcoming enhanced post-marketing safety surveillance systems.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27960593</PMID><DateCompleted><Year>2017</Year><Month>04</Month><Day>24</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2164-554X</ISSN><JournalIssue CitedMedium="Internet"><Volume>13</Volume><Issue>4</Issue><PubDate><Year>2017</Year><Month>04</Month><Day>03</Day></PubDate></JournalIssue><Title>Human vaccines & immunotherapeutics</Title><ISOAbbreviation>Hum Vaccin Immunother</ISOAbbreviation></Journal><ArticleTitle>Rapid safety assessment of a seasonal intradermal trivalent influenza vaccine.</ArticleTitle><Pagination><MedlinePgn>889-894</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/21645515.2016.1253644</ELocationID><Abstract><AbstractText>Seasonal influenza vaccine formulations must be updated annually to correspond to the influenza viruses in circulation. This was an uncontrolled, open-label, multi-center phase IV study conducted in Belgium to comply with interim European Medicines Agency (EMA) guidelines for rapidly evaluating the safety of newly formulated seasonal influenza vaccines. Adult volunteers received one dose of the 2014-2015 Northern Hemisphere formulation of licensed intradermal trivalent influenza vaccine at either the standard dose (9µg hemagglutinin/strain for 18-59 year-olds) or the high dose (15µg hemagglutinin/strain for ≥ 60 year-olds). Vaccinees recorded their solicited reactions and unsolicited adverse events for 7 d after vaccination. Solicited reaction frequencies were compared to historical reference values obtained from previous clinical trials to determine if the new formulations were excessively reactogenic or allergenic. A total of 210 participants (105 per age group) were included and vaccinated in October 2014. In both groups, pain, erythema, and pruritus were the most common solicited injection site reactions, and headache and myalgia were the most common solicited systemic reactions. Although the frequencies of shivering in 18-59 year-olds and malaise in ≥ 60 year-olds were higher than historical reference values, they were not considered indicative of excessive reactogenicity because almost all of these reactions were mild. The study design was endorsed by the EMA and permitted the reactogenicity of both vaccine formulations to be assessed within one month by collecting adverse events for 7 d. Both formulations exhibited acceptable safety profiles although this should be confirmed through forthcoming enhanced post-marketing safety surveillance systems.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Demeulemeester</LastName><ForeName>Marc</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>a Private practitioner , Gozée , Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lavis</LastName><ForeName>Nathalie</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>b Sanofi Pasteur , Lyon , France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Balthazar</LastName><ForeName>Yohan</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>c Private practitioner , Natoye , Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lechien</LastName><ForeName>Patrice</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>d Private practitioner , Braine-Le-Comte , Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Heijmans</LastName><ForeName>Stéphane</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>e Private practitioner , Linkebeek , Belgium.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017429">Clinical Trial, Phase IV</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>12</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Hum Vaccin Immunother</MedlineTA><NlmUniqueID>101572652</NlmUniqueID><ISSNLinking>2164-5515</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001530" MajorTopicYN="N">Belgium</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064368" MajorTopicYN="N">Healthy Volunteers</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007271" MajorTopicYN="N">Injections, Intradermal</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">clinical trial design</Keyword><Keyword MajorTopicYN="Y">inactivated influenza vaccine</Keyword><Keyword MajorTopicYN="Y">intradermal influenza vaccine</Keyword><Keyword MajorTopicYN="Y">vaccine safety</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>4</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27960593</ArticleId><ArticleId IdType="doi">10.1080/21645515.2016.1253644</ArticleId><ArticleId IdType="pmc">PMC5404648</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Vaccine. 2015 Oct 5;33(41):5425-31</Citation><ArticleIdList><ArticleId IdType="pubmed">26319063</ArticleId></ArticleIdList></Reference><Reference><Citation>Expert Rev Vaccines. 2010 Dec;9(12):1399-409</Citation><ArticleIdList><ArticleId IdType="pubmed">21105776</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur J Clin Microbiol Infect Dis. 1996 Jan;15(1):65-70</Citation><ArticleIdList><ArticleId IdType="pubmed">8641306</ArticleId></ArticleIdList></Reference><Reference><Citation>Hum Vaccin Immunother. 2013 Sep;9(9):1971-7</Citation><ArticleIdList><ArticleId IdType="pubmed">23778938</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2014 Aug 20;32(37):4713-25</Citation><ArticleIdList><ArticleId IdType="pubmed">24582632</ArticleId></ArticleIdList></Reference><Reference><Citation>MMWR Recomm Rep. 2013 Sep 20;62(RR-07):1-43</Citation><ArticleIdList><ArticleId IdType="pubmed">24048214</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Belgique</li><li>France</li></country></list><tree><country name="Belgique"><noRegion><name sortKey="Demeulemeester, Marc" sort="Demeulemeester, Marc" uniqKey="Demeulemeester M" first="Marc" last="Demeulemeester">Marc Demeulemeester</name></noRegion><name sortKey="Balthazar, Yohan" sort="Balthazar, Yohan" uniqKey="Balthazar Y" first="Yohan" last="Balthazar">Yohan Balthazar</name><name sortKey="Heijmans, Stephane" sort="Heijmans, Stephane" uniqKey="Heijmans S" first="Stéphane" last="Heijmans">Stéphane Heijmans</name><name sortKey="Lechien, Patrice" sort="Lechien, Patrice" uniqKey="Lechien P" first="Patrice" last="Lechien">Patrice Lechien</name></country><country name="France"><noRegion><name sortKey="Lavis, Nathalie" sort="Lavis, Nathalie" uniqKey="Lavis N" first="Nathalie" last="Lavis">Nathalie Lavis</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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