Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus
Abstract To evaluate the long-lasting immunogenicity and reactogenicity of a virosomal influenza vaccine in subjects with type I diabetes, a trial was conducted during the 2007–2008 influenza season in Milan, Northern Italy. One hundred five subjects aged 9–30 years were randomized to receive by int...
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description | Abstract To evaluate the long-lasting immunogenicity and reactogenicity of a virosomal influenza vaccine in subjects with type I diabetes, a trial was conducted during the 2007–2008 influenza season in Milan, Northern Italy. One hundred five subjects aged 9–30 years were randomized to receive by intramuscular injection vaccination by a single dose (0.5 ml) of either a virosomal (Inflexal V® ) ( n = 52) or a standard subunit (Influvac® ) ( n = 53) vaccine. Serum hemagglutinin inhibition antibody titres were determined against the three recommended influenza-like strains, A/H1N1, A/H3N2 and B, at pre-vaccination, and 1 and 6 months post-vaccination. Geometric mean titres were increased in the two groups 1 and 6 months post-vaccination ( P < 0.001). One month post-vaccination both vaccines met the CPMP requirement for immunogenicity with high seroprotection rates (>95%) for strains A/H1N1 and A/H3N2, and a seroprotection of 73% and 70% in the virosomal and subunit vaccine for strain B. Mean fold increase ranged 2.8 (A/H3N2)–6.2 (A/H1N1) in the virosomal group and 2.3 (A/H3N2)–4.8 (A/H1N1) in the subunit group. Immunogenicity declined 6 months post-vaccination in both groups, and the CPMP requirement for immunogenicity was satisfied only in the virosomal group. In subjects without pre-existing antibodies to strain B (titre |
doi_str_mv | 10.1016/j.vaccine.2009.06.082 |
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One hundred five subjects aged 9–30 years were randomized to receive by intramuscular injection vaccination by a single dose (0.5 ml) of either a virosomal (Inflexal V® ) ( n = 52) or a standard subunit (Influvac® ) ( n = 53) vaccine. Serum hemagglutinin inhibition antibody titres were determined against the three recommended influenza-like strains, A/H1N1, A/H3N2 and B, at pre-vaccination, and 1 and 6 months post-vaccination. Geometric mean titres were increased in the two groups 1 and 6 months post-vaccination ( P < 0.001). One month post-vaccination both vaccines met the CPMP requirement for immunogenicity with high seroprotection rates (>95%) for strains A/H1N1 and A/H3N2, and a seroprotection of 73% and 70% in the virosomal and subunit vaccine for strain B. Mean fold increase ranged 2.8 (A/H3N2)–6.2 (A/H1N1) in the virosomal group and 2.3 (A/H3N2)–4.8 (A/H1N1) in the subunit group. Immunogenicity declined 6 months post-vaccination in both groups, and the CPMP requirement for immunogenicity was satisfied only in the virosomal group. In subjects without pre-existing antibodies to strain B (titre <10), the virosomal vaccine showed higher immune response than the subunit vaccine 6 months post-vaccination, with a geometric mean titre (95% CI) of 40.2 (30.7–54.6) vs. 21.2 (14.6–30.8). Reactogenicity was similar in the two vaccines. All reactions were transient and not severe. The results indicate that in older children and young adults with type I diabetes influenza vaccination with a virosomal or a standard subunit vaccine is safe and adequately immunogenic against the three influenza vaccine strains. In addition, the virosomal vaccine may show better long-lasting immune response than the standard subunit vaccine, especially in subjects without pre-existing antibodies to influenza strains.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2009.06.082</identifier><identifier>PMID: 19607951</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Allergy and Immunology ; Antibodies, Viral - blood ; Applied microbiology ; Binomial distribution ; Biological and medical sciences ; Child ; Chronic illnesses ; Clinical medicine ; Confidence intervals ; Diabetes ; Diabetes mellitus ; Diabetes Mellitus, Type 1 - immunology ; Double-Blind Method ; Fundamental and applied biological sciences. Psychology ; Hospitals ; Humans ; Immune response ; Immunogenicity ; Influenza ; Influenza A Virus, H1N1 Subtype - immunology ; Influenza A Virus, H3N2 Subtype - immunology ; Influenza vaccine ; Influenza Vaccines - administration & dosage ; Influenza Vaccines - immunology ; Influenza, Human - prevention & control ; Microbiology ; Mortality ; Prospective Studies ; Reactogenicity ; Studies ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, Virosome - administration & dosage ; Vaccines, Virosome - immunology ; Virosomal ; Young Adult ; Young adults</subject><ispartof>Vaccine, 2009-08, Vol.27 (39), p.5357-5362</ispartof><rights>Elsevier Ltd</rights><rights>2009 Elsevier Ltd</rights><rights>2009 INIST-CNRS</rights><rights>Copyright Elsevier Limited Aug 27, 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c508t-79447f1727e3cbe0633c9ea5519aa2d240c00bd071013f13c5476f4a2fe1e6bd3</citedby><cites>FETCH-LOGICAL-c508t-79447f1727e3cbe0633c9ea5519aa2d240c00bd071013f13c5476f4a2fe1e6bd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1618902195?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974,64362,64364,64366,72216</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21879251$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19607951$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zuccotti, Gian Vincenzo</creatorcontrib><creatorcontrib>Scaramuzza, Andrea</creatorcontrib><creatorcontrib>Riboni, Sara</creatorcontrib><creatorcontrib>Mameli, Chiara</creatorcontrib><creatorcontrib>Pariani, Elena</creatorcontrib><creatorcontrib>Tanzi, Elisabetta</creatorcontrib><creatorcontrib>Zanetti, Alessandro</creatorcontrib><creatorcontrib>Radaelli, Giovanni</creatorcontrib><title>Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Abstract To evaluate the long-lasting immunogenicity and reactogenicity of a virosomal influenza vaccine in subjects with type I diabetes, a trial was conducted during the 2007–2008 influenza season in Milan, Northern Italy. One hundred five subjects aged 9–30 years were randomized to receive by intramuscular injection vaccination by a single dose (0.5 ml) of either a virosomal (Inflexal V® ) ( n = 52) or a standard subunit (Influvac® ) ( n = 53) vaccine. Serum hemagglutinin inhibition antibody titres were determined against the three recommended influenza-like strains, A/H1N1, A/H3N2 and B, at pre-vaccination, and 1 and 6 months post-vaccination. Geometric mean titres were increased in the two groups 1 and 6 months post-vaccination ( P < 0.001). One month post-vaccination both vaccines met the CPMP requirement for immunogenicity with high seroprotection rates (>95%) for strains A/H1N1 and A/H3N2, and a seroprotection of 73% and 70% in the virosomal and subunit vaccine for strain B. Mean fold increase ranged 2.8 (A/H3N2)–6.2 (A/H1N1) in the virosomal group and 2.3 (A/H3N2)–4.8 (A/H1N1) in the subunit group. Immunogenicity declined 6 months post-vaccination in both groups, and the CPMP requirement for immunogenicity was satisfied only in the virosomal group. In subjects without pre-existing antibodies to strain B (titre <10), the virosomal vaccine showed higher immune response than the subunit vaccine 6 months post-vaccination, with a geometric mean titre (95% CI) of 40.2 (30.7–54.6) vs. 21.2 (14.6–30.8). Reactogenicity was similar in the two vaccines. All reactions were transient and not severe. The results indicate that in older children and young adults with type I diabetes influenza vaccination with a virosomal or a standard subunit vaccine is safe and adequately immunogenic against the three influenza vaccine strains. In addition, the virosomal vaccine may show better long-lasting immune response than the standard subunit vaccine, especially in subjects without pre-existing antibodies to influenza strains.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Allergy and Immunology</subject><subject>Antibodies, Viral - blood</subject><subject>Applied microbiology</subject><subject>Binomial distribution</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Chronic illnesses</subject><subject>Clinical medicine</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes Mellitus, Type 1 - immunology</subject><subject>Double-Blind Method</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunogenicity</subject><subject>Influenza</subject><subject>Influenza A Virus, H1N1 Subtype - immunology</subject><subject>Influenza A Virus, H3N2 Subtype - immunology</subject><subject>Influenza vaccine</subject><subject>Influenza Vaccines - administration & dosage</subject><subject>Influenza Vaccines - immunology</subject><subject>Influenza, Human - prevention & control</subject><subject>Microbiology</subject><subject>Mortality</subject><subject>Prospective Studies</subject><subject>Reactogenicity</subject><subject>Studies</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Vaccines, Virosome - administration & dosage</subject><subject>Vaccines, Virosome - immunology</subject><subject>Virosomal</subject><subject>Young Adult</subject><subject>Young adults</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkk-P0zAQxSMEYsvCRwBZQsApZWwnTnwBoRV_VqrEAZC4Wa4z6bo4drGTonx7XBqx0h7g5Mtvnmfee0XxlMKaAhWv9-ujNsZ6XDMAuQaxhpbdK1a0bXjJatreL1bARFVWFL5fFI9S2gNAzal8WFxQKaCRNV0VaRP8rnQ6jdbviB2GyYcdemvsOJPQE02ONoYUBu3I8iGxngTXYSTmxrouoifad2QOU1bQ3eTGRH7Z8YaM8wHJNems3uKIiQzonB2n9Lh40GuX8MnyXhbfPrz_evWp3Hz-eH31blOaGtqxbGRVNT1tWIPcbBEE50airmsqtWYdq8AAbDtosh-8p9zUVSP6SrMeKYptxy-LV2fdQww_J0yjGmwyeQntMUxJNVV2oakYZPLlP0nR1C1nnGbw-R1wH6bo8xWKCtpKYFTWmarPlMnWpYi9OkQ76DgrCuqUntqrxUx1Sk-BUDm9PPdsUZ-2A3a3U0tcGXixADoZ7fqovbHpL8dy-JL94d6eOcz2Hi1GlYxFb7CzEc2oumD_u8qbOwrG2VwL7X7gjOn2apWYAvXlVLVT00BmEQEt_w3_es_b</recordid><startdate>20090827</startdate><enddate>20090827</enddate><creator>Zuccotti, Gian Vincenzo</creator><creator>Scaramuzza, Andrea</creator><creator>Riboni, Sara</creator><creator>Mameli, Chiara</creator><creator>Pariani, Elena</creator><creator>Tanzi, Elisabetta</creator><creator>Zanetti, Alessandro</creator><creator>Radaelli, Giovanni</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</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>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20090827</creationdate><title>Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus</title><author>Zuccotti, Gian Vincenzo ; Scaramuzza, Andrea ; Riboni, Sara ; Mameli, Chiara ; Pariani, Elena ; Tanzi, Elisabetta ; Zanetti, Alessandro ; Radaelli, Giovanni</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c508t-79447f1727e3cbe0633c9ea5519aa2d240c00bd071013f13c5476f4a2fe1e6bd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Allergy and Immunology</topic><topic>Antibodies, Viral - blood</topic><topic>Applied microbiology</topic><topic>Binomial distribution</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Chronic illnesses</topic><topic>Clinical medicine</topic><topic>Confidence intervals</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes Mellitus, Type 1 - immunology</topic><topic>Double-Blind Method</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Immune response</topic><topic>Immunogenicity</topic><topic>Influenza</topic><topic>Influenza A Virus, H1N1 Subtype - immunology</topic><topic>Influenza A Virus, H3N2 Subtype - immunology</topic><topic>Influenza vaccine</topic><topic>Influenza Vaccines - administration & dosage</topic><topic>Influenza Vaccines - immunology</topic><topic>Influenza, Human - prevention & control</topic><topic>Microbiology</topic><topic>Mortality</topic><topic>Prospective Studies</topic><topic>Reactogenicity</topic><topic>Studies</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Vaccines, Virosome - administration & dosage</topic><topic>Vaccines, Virosome - immunology</topic><topic>Virosomal</topic><topic>Young Adult</topic><topic>Young adults</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zuccotti, Gian Vincenzo</creatorcontrib><creatorcontrib>Scaramuzza, Andrea</creatorcontrib><creatorcontrib>Riboni, Sara</creatorcontrib><creatorcontrib>Mameli, Chiara</creatorcontrib><creatorcontrib>Pariani, Elena</creatorcontrib><creatorcontrib>Tanzi, Elisabetta</creatorcontrib><creatorcontrib>Zanetti, Alessandro</creatorcontrib><creatorcontrib>Radaelli, Giovanni</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>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zuccotti, Gian Vincenzo</au><au>Scaramuzza, Andrea</au><au>Riboni, Sara</au><au>Mameli, Chiara</au><au>Pariani, Elena</au><au>Tanzi, Elisabetta</au><au>Zanetti, Alessandro</au><au>Radaelli, Giovanni</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2009-08-27</date><risdate>2009</risdate><volume>27</volume><issue>39</issue><spage>5357</spage><epage>5362</epage><pages>5357-5362</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Abstract To evaluate the long-lasting immunogenicity and reactogenicity of a virosomal influenza vaccine in subjects with type I diabetes, a trial was conducted during the 2007–2008 influenza season in Milan, Northern Italy. One hundred five subjects aged 9–30 years were randomized to receive by intramuscular injection vaccination by a single dose (0.5 ml) of either a virosomal (Inflexal V® ) ( n = 52) or a standard subunit (Influvac® ) ( n = 53) vaccine. Serum hemagglutinin inhibition antibody titres were determined against the three recommended influenza-like strains, A/H1N1, A/H3N2 and B, at pre-vaccination, and 1 and 6 months post-vaccination. Geometric mean titres were increased in the two groups 1 and 6 months post-vaccination ( P < 0.001). One month post-vaccination both vaccines met the CPMP requirement for immunogenicity with high seroprotection rates (>95%) for strains A/H1N1 and A/H3N2, and a seroprotection of 73% and 70% in the virosomal and subunit vaccine for strain B. Mean fold increase ranged 2.8 (A/H3N2)–6.2 (A/H1N1) in the virosomal group and 2.3 (A/H3N2)–4.8 (A/H1N1) in the subunit group. Immunogenicity declined 6 months post-vaccination in both groups, and the CPMP requirement for immunogenicity was satisfied only in the virosomal group. In subjects without pre-existing antibodies to strain B (titre <10), the virosomal vaccine showed higher immune response than the subunit vaccine 6 months post-vaccination, with a geometric mean titre (95% CI) of 40.2 (30.7–54.6) vs. 21.2 (14.6–30.8). Reactogenicity was similar in the two vaccines. All reactions were transient and not severe. The results indicate that in older children and young adults with type I diabetes influenza vaccination with a virosomal or a standard subunit vaccine is safe and adequately immunogenic against the three influenza vaccine strains. In addition, the virosomal vaccine may show better long-lasting immune response than the standard subunit vaccine, especially in subjects without pre-existing antibodies to influenza strains.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>19607951</pmid><doi>10.1016/j.vaccine.2009.06.082</doi><tpages>6</tpages></addata></record> |
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subjects | Adolescent Adult Allergy and Immunology Antibodies, Viral - blood Applied microbiology Binomial distribution Biological and medical sciences Child Chronic illnesses Clinical medicine Confidence intervals Diabetes Diabetes mellitus Diabetes Mellitus, Type 1 - immunology Double-Blind Method Fundamental and applied biological sciences. Psychology Hospitals Humans Immune response Immunogenicity Influenza Influenza A Virus, H1N1 Subtype - immunology Influenza A Virus, H3N2 Subtype - immunology Influenza vaccine Influenza Vaccines - administration & dosage Influenza Vaccines - immunology Influenza, Human - prevention & control Microbiology Mortality Prospective Studies Reactogenicity Studies Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Virosome - administration & dosage Vaccines, Virosome - immunology Virosomal Young Adult Young adults |
title | Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus |
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