<?xml version="1.0" encoding="utf-8"?>
<TEI xmlns="http://www.tei-c.org/ns/1.0" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:hal="http://hal.archives-ouvertes.fr/" xmlns:gml="http://www.opengis.net/gml/3.3/" xmlns:gmlce="http://www.opengis.net/gml/3.3/ce" version="1.1" xsi:schemaLocation="http://www.tei-c.org/ns/1.0 http://api.archives-ouvertes.fr/documents/aofr-sword.xsd">
  <teiHeader>
    <fileDesc>
      <titleStmt>
        <title>HAL TEI export of inserm-00339872</title>
      </titleStmt>
      <publicationStmt>
        <distributor>CCSD</distributor>
        <availability status="restricted">
          <licence target="https://creativecommons.org/publicdomain/zero/1.0/">CC0 1.0 - Universal</licence>
        </availability>
        <date when="2026-05-20T16:19:17+02:00"/>
      </publicationStmt>
      <sourceDesc>
        <p part="N">HAL API Platform</p>
      </sourceDesc>
    </fileDesc>
  </teiHeader>
  <text>
    <body>
      <listBibl>
        <biblFull>
          <titleStmt>
            <title xml:lang="en">A new endpoint definition improved clinical relevance and statistical power in a vaccine trial.</title>
            <title xml:lang="en" type="sub">New endpoint formulation for vaccine trials</title>
            <author role="aut">
              <persName>
                <forename type="first">Gaëlle</forename>
                <surname>Pédrono</surname>
              </persName>
              <idno type="halauthorid">365027-0</idno>
              <affiliation ref="#struct-55677"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Rodolphe</forename>
                <surname>Thiébaut</surname>
              </persName>
              <email type="md5">242f217052cdd1b15e9288ab507c175b</email>
              <email type="domain">u-bordeaux.fr</email>
              <idno type="idhal" notation="string">rodolphe-thiebaut</idno>
              <idno type="idhal" notation="numeric">175125</idno>
              <idno type="halauthorid" notation="string">32082-175125</idno>
              <idno type="ORCID">https://orcid.org/0000-0002-5235-3962</idno>
              <idno type="IDREF">https://www.idref.fr/071580735</idno>
              <affiliation ref="#struct-55677"/>
              <affiliation ref="#struct-8402"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Ahmadou</forename>
                <surname>Alioum</surname>
              </persName>
              <email type="md5">6c78f227e8447b0173b609d3414f9a38</email>
              <email type="domain">isped.u-borfeaux2.fr</email>
              <idno type="idhal" notation="numeric">847537</idno>
              <idno type="halauthorid" notation="string">229426-847537</idno>
              <affiliation ref="#struct-55677"/>
              <affiliation ref="#struct-8402"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Philippe</forename>
                <surname>Lesprit</surname>
              </persName>
              <idno type="halauthorid">365028-0</idno>
              <affiliation ref="#struct-29301"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Bernard</forename>
                <surname>Fritzell</surname>
              </persName>
              <idno type="halauthorid">365029-0</idno>
              <affiliation ref="#struct-89408"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Yves</forename>
                <surname>Lévy</surname>
              </persName>
              <email type="md5">9858d2cc869e5bf886749f3e55bffd8a</email>
              <email type="domain">hmn.aphp.fr</email>
              <idno type="idhal" notation="numeric">759951</idno>
              <idno type="halauthorid" notation="string">321458-759951</idno>
              <idno type="ORCID">https://orcid.org/0000-0002-5549-6256</idno>
              <idno type="ORCID">https://orcid.org/0000-0002-4224-3137</idno>
              <idno type="IDREF">https://www.idref.fr/032554796</idno>
              <affiliation ref="#struct-29301"/>
            </author>
            <author role="crp">
              <persName>
                <forename type="first">Geneviève</forename>
                <surname>Chêne</surname>
              </persName>
              <email type="md5">0e79cbeaa65e57d0de03d25fdbb0b191</email>
              <email type="domain">isped.u-bordeaux2.fr</email>
              <idno type="idhal" notation="numeric">842202</idno>
              <idno type="halauthorid" notation="string">131533-842202</idno>
              <idno type="ORCID">https://orcid.org/0000-0002-8368-6460</idno>
              <affiliation ref="#struct-55677"/>
            </author>
            <editor role="depositor">
              <persName>
                <forename>Evelyne</forename>
                <surname>Mouillet</surname>
              </persName>
              <email type="md5">e0c2be611c4ac9b51370e29f4218b8f6</email>
              <email type="domain">isped.u-bordeaux2.fr</email>
            </editor>
          </titleStmt>
          <editionStmt>
            <edition n="v1" type="current">
              <date type="whenSubmitted">2008-11-19 11:38:38</date>
              <date type="whenModified">2026-04-02 17:12:03</date>
              <date type="whenReleased">2009-03-17 13:51:21</date>
              <date type="whenProduced">2009-10</date>
              <date type="whenEndEmbargoed">2008-11-19</date>
              <ref type="file" target="https://inserm.hal.science/inserm-00339872v1/document">
                <date notBefore="2008-11-19"/>
              </ref>
              <ref type="file" subtype="author" n="1" target="https://inserm.hal.science/inserm-00339872v1/file/Article_methodo_pneumovac_draft_final.pdf" id="file-339872-268400">
                <date notBefore="2008-11-19"/>
              </ref>
              <ref type="externalLink" target="http://www.hal.inserm.fr/inserm-00339872/file/Article_methodo_pneumovac_draft_final.pdf"/>
            </edition>
            <respStmt>
              <resp>contributor</resp>
              <name key="116846">
                <persName>
                  <forename>Evelyne</forename>
                  <surname>Mouillet</surname>
                </persName>
                <email type="md5">e0c2be611c4ac9b51370e29f4218b8f6</email>
                <email type="domain">isped.u-bordeaux2.fr</email>
              </name>
            </respStmt>
          </editionStmt>
          <publicationStmt>
            <distributor>CCSD</distributor>
            <idno type="halId">inserm-00339872</idno>
            <idno type="halUri">https://inserm.hal.science/inserm-00339872</idno>
            <idno type="halBibtex">pedrono:inserm-00339872</idno>
            <idno type="halRefHtml">&lt;i&gt;Journal of Clinical Epidemiology&lt;/i&gt;, 2009, 62 (10), pp.1054-61. &lt;a target="_blank" href="https://dx.doi.org/10.1016/j.jclinepi.2008.10.014"&gt;&amp;#x27E8;10.1016/j.jclinepi.2008.10.014&amp;#x27E9;&lt;/a&gt;</idno>
            <idno type="halRef">Journal of Clinical Epidemiology, 2009, 62 (10), pp.1054-61. &amp;#x27E8;10.1016/j.jclinepi.2008.10.014&amp;#x27E9;</idno>
            <availability status="restricted">
              <licence target="https://about.hal.science/hal-authorisation-v1/">HAL Authorization<ref corresp="#file-339872-268400"/></licence>
            </availability>
          </publicationStmt>
          <seriesStmt>
            <idno type="stamp" n="INSERM">INSERM - Institut national de la santé et de la recherche médicale</idno>
            <idno type="stamp" n="APHP" corresp="INSERM">AP-HP</idno>
            <idno type="stamp" n="SANTE_PUB_INSERM" corresp="INSERM">Santé Publique à l'Inserm</idno>
            <idno type="stamp" n="UPEC" corresp="CV_UPEC">Université Paris-Est Créteil Val-de-Marne</idno>
          </seriesStmt>
          <notesStmt>
            <note type="audience" n="2">International</note>
            <note type="popular" n="0">No</note>
            <note type="peer" n="1">Yes</note>
          </notesStmt>
          <sourceDesc>
            <biblStruct>
              <analytic>
                <title xml:lang="en">A new endpoint definition improved clinical relevance and statistical power in a vaccine trial.</title>
                <title xml:lang="en" type="sub">New endpoint formulation for vaccine trials</title>
                <author role="aut">
                  <persName>
                    <forename type="first">Gaëlle</forename>
                    <surname>Pédrono</surname>
                  </persName>
                  <idno type="halauthorid">365027-0</idno>
                  <affiliation ref="#struct-55677"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Rodolphe</forename>
                    <surname>Thiébaut</surname>
                  </persName>
                  <email type="md5">242f217052cdd1b15e9288ab507c175b</email>
                  <email type="domain">u-bordeaux.fr</email>
                  <idno type="idhal" notation="string">rodolphe-thiebaut</idno>
                  <idno type="idhal" notation="numeric">175125</idno>
                  <idno type="halauthorid" notation="string">32082-175125</idno>
                  <idno type="ORCID">https://orcid.org/0000-0002-5235-3962</idno>
                  <idno type="IDREF">https://www.idref.fr/071580735</idno>
                  <affiliation ref="#struct-55677"/>
                  <affiliation ref="#struct-8402"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Ahmadou</forename>
                    <surname>Alioum</surname>
                  </persName>
                  <email type="md5">6c78f227e8447b0173b609d3414f9a38</email>
                  <email type="domain">isped.u-borfeaux2.fr</email>
                  <idno type="idhal" notation="numeric">847537</idno>
                  <idno type="halauthorid" notation="string">229426-847537</idno>
                  <affiliation ref="#struct-55677"/>
                  <affiliation ref="#struct-8402"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Philippe</forename>
                    <surname>Lesprit</surname>
                  </persName>
                  <idno type="halauthorid">365028-0</idno>
                  <affiliation ref="#struct-29301"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Bernard</forename>
                    <surname>Fritzell</surname>
                  </persName>
                  <idno type="halauthorid">365029-0</idno>
                  <affiliation ref="#struct-89408"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Yves</forename>
                    <surname>Lévy</surname>
                  </persName>
                  <email type="md5">9858d2cc869e5bf886749f3e55bffd8a</email>
                  <email type="domain">hmn.aphp.fr</email>
                  <idno type="idhal" notation="numeric">759951</idno>
                  <idno type="halauthorid" notation="string">321458-759951</idno>
                  <idno type="ORCID">https://orcid.org/0000-0002-5549-6256</idno>
                  <idno type="ORCID">https://orcid.org/0000-0002-4224-3137</idno>
                  <idno type="IDREF">https://www.idref.fr/032554796</idno>
                  <affiliation ref="#struct-29301"/>
                </author>
                <author role="crp">
                  <persName>
                    <forename type="first">Geneviève</forename>
                    <surname>Chêne</surname>
                  </persName>
                  <email type="md5">0e79cbeaa65e57d0de03d25fdbb0b191</email>
                  <email type="domain">isped.u-bordeaux2.fr</email>
                  <idno type="idhal" notation="numeric">842202</idno>
                  <idno type="halauthorid" notation="string">131533-842202</idno>
                  <idno type="ORCID">https://orcid.org/0000-0002-8368-6460</idno>
                  <affiliation ref="#struct-55677"/>
                </author>
              </analytic>
              <monogr>
                <idno type="halJournalId" status="VALID">15222</idno>
                <idno type="issn">0895-4356</idno>
                <idno type="eissn">1878-5921</idno>
                <title level="j">Journal of Clinical Epidemiology</title>
                <imprint>
                  <publisher>Elsevier</publisher>
                  <biblScope unit="volume">62</biblScope>
                  <biblScope unit="issue">10</biblScope>
                  <biblScope unit="pp">1054-61</biblScope>
                  <date type="datePub">2009-10</date>
                  <date type="dateEpub">2009-03-17</date>
                </imprint>
              </monogr>
              <idno type="doi">10.1016/j.jclinepi.2008.10.014</idno>
              <idno type="pubmed">19282146</idno>
            </biblStruct>
          </sourceDesc>
          <profileDesc>
            <langUsage>
              <language ident="en">English</language>
            </langUsage>
            <textClass>
              <keywords scheme="author">
                <term xml:lang="en">random effect</term>
                <term xml:lang="en">Vaccine</term>
                <term xml:lang="en">endpoint</term>
                <term xml:lang="en">proportional odds model</term>
                <term xml:lang="en">HIV infection</term>
                <term xml:lang="en">statistical power</term>
                <term xml:lang="en">random effect.</term>
              </keywords>
              <classCode scheme="mesh">AIDS-Related Opportunistic Infections</classCode>
              <classCode scheme="mesh">Adult</classCode>
              <classCode scheme="mesh">Antibodies, Bacterial</classCode>
              <classCode scheme="mesh">Data Interpretation, Statistical</classCode>
              <classCode scheme="mesh">Humans</classCode>
              <classCode scheme="mesh">Pneumococcal Infections</classCode>
              <classCode scheme="mesh">Pneumococcal Vaccines</classCode>
              <classCode scheme="mesh">Research Design</classCode>
              <classCode scheme="mesh">Streptococcus pneumoniae</classCode>
              <classCode scheme="mesh">Treatment Outcome</classCode>
              <classCode scheme="halDomain" n="sdv.spee">Life Sciences [q-bio]/Santé publique et épidémiologie</classCode>
              <classCode scheme="halTypology" n="ART">Journal articles</classCode>
              <classCode scheme="halOldTypology" n="ART">Journal articles</classCode>
              <classCode scheme="halTreeTypology" n="ART">Journal articles</classCode>
            </textClass>
            <abstract xml:lang="en">
              <p>OBJECTIVE: Endpoints used for the evaluation of immunogenicity in vaccine trials are often the proportion of individuals with immune response or geometric means of antibody concentrations for each serotype. When a vaccine includes several types of the same species, we illustrate how an endpoint combining all responses may improve clinical relevance and statistical power. STUDY DESIGN AND SETTINGS: The motivating example was the ANRS 114 Pneumovac trial where the effect of two vaccine strategies against Streptococcus pneumoniae was assessed in adults infected by the Human Immunodeficiency Virus. The power associated with several endpoints was calculated in the example and in simulations. A new endpoint based on four ordered levels is formulated and analyzed by using a proportional odds model. RESULTS AND CONCLUSION: The analysis of this new endpoint led to an odds ratio allowing detection of improvement and detriment. In the simulation study, this endpoint was associated with the largest statistical power by increasing the amount of information used as compared with usual endpoints. We recommend this new endpoint formulation in the formal development of a new vaccination regimen, whenever applicable.</p>
            </abstract>
          </profileDesc>
        </biblFull>
      </listBibl>
    </body>
    <back>
      <listOrg type="structures">
        <org type="laboratory" xml:id="struct-55677" status="OLD">
          <orgName>Epidémiologie et Biostatistique [Bordeaux]</orgName>
          <desc>
            <address>
              <addrLine>146, rue Léo-Saignat 33076 Bordeaux</addrLine>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-91134" type="direct"/>
            <relation name="U897" active="#struct-303623" type="direct"/>
          </listRelation>
        </org>
        <org type="laboratory" xml:id="struct-8402" status="VALID">
          <orgName>Institut de Santé Publique, d'Epidémiologie et de Développement</orgName>
          <orgName type="acronym">ISPED</orgName>
          <desc>
            <address>
              <addrLine>146 rue Léo Signat 33076 Bordeaux Cedex</addrLine>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-91134" type="direct"/>
          </listRelation>
        </org>
        <org type="laboratory" xml:id="struct-29301" status="VALID">
          <orgName>Hôpital Henri Mondor</orgName>
          <desc>
            <address>
              <addrLine>Créteil</addrLine>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-300068" type="direct"/>
            <relation active="#struct-366262" type="direct"/>
            <relation active="#struct-103061" type="indirect"/>
            <relation active="#struct-420786" type="direct"/>
          </listRelation>
        </org>
        <org type="laboratory" xml:id="struct-89408" status="INCOMING">
          <orgName>Wyeth-research</orgName>
          <desc>
            <address>
              <addrLine>Paris</addrLine>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-322302" type="direct"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-91134" status="OLD">
          <orgName>Université Bordeaux Segalen - Bordeaux 2</orgName>
          <desc>
            <address>
              <addrLine>146 rue Léo Saignat - 33076 Bordeaux cedex</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.univ-bordeauxsegalen.fr/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-303623" status="VALID">
          <idno type="IdRef">026388278</idno>
          <idno type="ROR">https://ror.org/02vjkv261</idno>
          <orgName>Institut National de la Santé et de la Recherche Médicale</orgName>
          <orgName type="acronym">INSERM</orgName>
          <desc>
            <address>
              <addrLine>101, rue de Tolbiac, 75013 Paris</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.inserm.fr</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-300068" status="VALID">
          <idno type="ROR">https://ror.org/00pg5jh14</idno>
          <orgName>Assistance publique - Hôpitaux de Paris (AP-HP)</orgName>
          <orgName type="acronym">AP-HP</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
        </org>
        <org type="institution" xml:id="struct-366262" status="VALID">
          <idno type="ROR">https://ror.org/04m61mj84</idno>
          <orgName>CHU Henri Mondor [Créteil]</orgName>
          <desc>
            <address>
              <addrLine>51, avenue du Maréchal de Lattre de Tassigny 94000 Créteil</addrLine>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-103061" type="direct"/>
            <relation active="#struct-300068" type="direct"/>
          </listRelation>
        </org>
        <org type="regroupinstitution" xml:id="struct-103061" status="VALID">
          <orgName>Groupe Henri Mondor-Albert Chenevier</orgName>
          <desc>
            <address>
              <addrLine>Créteil</addrLine>
              <country key="FR"/>
            </address>
          </desc>
        </org>
        <org type="institution" xml:id="struct-420786" status="VALID">
          <idno type="IdRef">028021037</idno>
          <idno type="ISNI">0000000121497878</idno>
          <idno type="ROR">https://ror.org/05ggc9x40</idno>
          <orgName>Université Paris-Est Créteil Val-de-Marne - Paris 12</orgName>
          <orgName type="acronym">UPEC UP12</orgName>
          <date type="start">1970-01-01</date>
          <desc>
            <address>
              <addrLine>61 avenue du Général de Gaulle - 94010 Créteil cedex</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.u-pec.fr/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-322302" status="INCOMING">
          <orgName>Wyeth</orgName>
          <desc>
            <address>
              <country key="FR"/>
            </address>
          </desc>
        </org>
      </listOrg>
    </back>
  </text>
</TEI>