Safety and immunogenicity of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine administered in a dual-chamber syringe to infants in Belgium and Chile.
Identifieur interne : 000113 ( Main/Corpus ); précédent : 000112; suivant : 000114Safety and immunogenicity of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine administered in a dual-chamber syringe to infants in Belgium and Chile.
Auteurs : K. Hoppenbrouwers ; R. Lagos ; B. Swennen ; C. Ethevenaux ; J. Knops ; M M Levine ; J. DesmyterSource :
- Vaccine [ 0264-410X ]
English descriptors
- KwdEn :
- Antibodies, Bacterial (blood), Belgium, Chile, Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage), Diphtheria-Tetanus-Pertussis Vaccine (adverse effects), Diphtheria-Tetanus-Pertussis Vaccine (immunology), Female, Haemophilus Vaccines (administration & dosage), Haemophilus Vaccines (adverse effects), Haemophilus Vaccines (immunology), Humans, Immunization Schedule, Infant, Male, Safety, Syringes, Tetanus Toxoid (administration & dosage), Tetanus Toxoid (adverse effects), Tetanus Toxoid (immunology), Vaccines, Conjugate (administration & dosage), Vaccines, Conjugate (adverse effects), Vaccines, Conjugate (immunology).
- MESH :
- chemical , administration & dosage : Diphtheria-Tetanus-Pertussis Vaccine, Haemophilus Vaccines, Tetanus Toxoid, Vaccines, Conjugate.
- chemical , adverse effects : Diphtheria-Tetanus-Pertussis Vaccine, Haemophilus Vaccines, Tetanus Toxoid, Vaccines, Conjugate.
- chemical , blood : Antibodies, Bacterial.
- chemical , immunology : Diphtheria-Tetanus-Pertussis Vaccine, Haemophilus Vaccines, Tetanus Toxoid, Vaccines, Conjugate.
- geographic : Belgium, Chile.
- Female, Humans, Immunization Schedule, Infant, Male, Safety, Syringes.
Abstract
To document any unexpected differences in the immune response between study populations and to evaluate immunogenicity and safety of a simplified presentation (dual-chamber syringe) of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine, a multicentre, randomized, comparative study was conducted in Belgium and Chile. A total of 537 healthy infants, 270 in Chile and 267 in Belgium, received PRP-T and DTP vaccines combined in a dual-chamber syringe (D-Ch group, DTP/PRP-T, reconstituted by pressing the plunger of the syringe immediately before injection, n = 239) or combined in a single-chamber syringe (C-In group, DTP@PRP-T, reconstituted immediately before injection, n = 61) or in separate injections (S-In group, DTP + PRP-T, simultaneously injected at separate sites, n = 237) at 3, 4, and 5 months of age. Serum samples were collected before vaccination and at 6 months of age. In the D-Ch group, the incidence of adverse events was comparable to administration of DTP vaccine alone. Higher rates of local and systemic reactions were observed in the Chilean population, possibly due to differences in surveillance practice. The immune response to each vaccine component compared well to that of the separate administration of PRP-T and DTP vaccines, except for higher post-immunization anti-PRP geometric mean titre (GMT) values after separate injections (25.6 micrograms mL-1) than after combined injection with the dual-chamber syringe (17.6 micrograms mL-1) (p = 0.001). An unexpected 'syringe' effect was seen: a greater post-immunization anti-PRP GMT was observed in the D-Ch group (17.6 micrograms mL-1) than in the C-In group (7.7 micrograms mL-1) (p = 0.0001). Whereas pre-immunization GMTs of some antibodies were significantly lower in Chilean than in Belgian infants, the post-immunization GMTs of Chilean infants were two to three times greater for all of the antibodies studied (p < 0.005). Differences in reactogenicity and in the immune response between the study populations or the different vaccine presentations were striking, but are probably of no clinical relevance. The convenient dual-chamber syringe presentation of DTP and PRP-T vaccines is safe and highly immunogenic.
DOI: 10.1016/s0264-410x(97)00303-4
PubMed: 9682338
Links to Exploration step
pubmed:9682338Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety and immunogenicity of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine administered in a dual-chamber syringe to infants in Belgium and Chile.</title><author><name sortKey="Hoppenbrouwers, K" sort="Hoppenbrouwers, K" uniqKey="Hoppenbrouwers K" first="K" last="Hoppenbrouwers">K. Hoppenbrouwers</name><affiliation><nlm:affiliation>Department of Youth Health Care, Katholieke Universiteit Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Lagos, R" sort="Lagos, R" uniqKey="Lagos R" first="R" last="Lagos">R. Lagos</name></author><author><name sortKey="Swennen, B" sort="Swennen, B" uniqKey="Swennen B" first="B" last="Swennen">B. Swennen</name></author><author><name sortKey="Ethevenaux, C" sort="Ethevenaux, C" uniqKey="Ethevenaux C" first="C" last="Ethevenaux">C. Ethevenaux</name></author><author><name sortKey="Knops, J" sort="Knops, J" uniqKey="Knops J" first="J" last="Knops">J. Knops</name></author><author><name sortKey="Levine, M M" sort="Levine, M M" uniqKey="Levine M" first="M M" last="Levine">M M Levine</name></author><author><name sortKey="Desmyter, J" sort="Desmyter, J" uniqKey="Desmyter J" first="J" last="Desmyter">J. Desmyter</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="????"><PubDate><MedlineDate>1998 May-Jun</MedlineDate></PubDate></date><idno type="RBID">pubmed:9682338</idno><idno type="pmid">9682338</idno><idno type="doi">10.1016/s0264-410x(97)00303-4</idno><idno type="wicri:Area/Main/Corpus">000113</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000113</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and immunogenicity of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine administered in a dual-chamber syringe to infants in Belgium and Chile.</title><author><name sortKey="Hoppenbrouwers, K" sort="Hoppenbrouwers, K" uniqKey="Hoppenbrouwers K" first="K" last="Hoppenbrouwers">K. Hoppenbrouwers</name><affiliation><nlm:affiliation>Department of Youth Health Care, Katholieke Universiteit Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Lagos, R" sort="Lagos, R" uniqKey="Lagos R" first="R" last="Lagos">R. Lagos</name></author><author><name sortKey="Swennen, B" sort="Swennen, B" uniqKey="Swennen B" first="B" last="Swennen">B. Swennen</name></author><author><name sortKey="Ethevenaux, C" sort="Ethevenaux, C" uniqKey="Ethevenaux C" first="C" last="Ethevenaux">C. Ethevenaux</name></author><author><name sortKey="Knops, J" sort="Knops, J" uniqKey="Knops J" first="J" last="Knops">J. Knops</name></author><author><name sortKey="Levine, M M" sort="Levine, M M" uniqKey="Levine M" first="M M" last="Levine">M M Levine</name></author><author><name sortKey="Desmyter, J" sort="Desmyter, J" uniqKey="Desmyter J" first="J" last="Desmyter">J. Desmyter</name></author></analytic><series><title level="j">Vaccine</title><idno type="ISSN">0264-410X</idno></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibodies, Bacterial (blood)</term><term>Belgium</term><term>Chile</term><term>Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage)</term><term>Diphtheria-Tetanus-Pertussis Vaccine (adverse effects)</term><term>Diphtheria-Tetanus-Pertussis Vaccine (immunology)</term><term>Female</term><term>Haemophilus Vaccines (administration & dosage)</term><term>Haemophilus Vaccines (adverse effects)</term><term>Haemophilus Vaccines (immunology)</term><term>Humans</term><term>Immunization Schedule</term><term>Infant</term><term>Male</term><term>Safety</term><term>Syringes</term><term>Tetanus Toxoid (administration & dosage)</term><term>Tetanus Toxoid (adverse effects)</term><term>Tetanus Toxoid (immunology)</term><term>Vaccines, Conjugate (administration & dosage)</term><term>Vaccines, Conjugate (adverse effects)</term><term>Vaccines, Conjugate (immunology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Diphtheria-Tetanus-Pertussis Vaccine</term><term>Haemophilus Vaccines</term><term>Tetanus Toxoid</term><term>Vaccines, Conjugate</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Diphtheria-Tetanus-Pertussis Vaccine</term><term>Haemophilus Vaccines</term><term>Tetanus Toxoid</term><term>Vaccines, Conjugate</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Bacterial</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Diphtheria-Tetanus-Pertussis Vaccine</term><term>Haemophilus Vaccines</term><term>Tetanus Toxoid</term><term>Vaccines, Conjugate</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Belgium</term><term>Chile</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Female</term><term>Humans</term><term>Immunization Schedule</term><term>Infant</term><term>Male</term><term>Safety</term><term>Syringes</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">To document any unexpected differences in the immune response between study populations and to evaluate immunogenicity and safety of a simplified presentation (dual-chamber syringe) of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine, a multicentre, randomized, comparative study was conducted in Belgium and Chile. A total of 537 healthy infants, 270 in Chile and 267 in Belgium, received PRP-T and DTP vaccines combined in a dual-chamber syringe (D-Ch group, DTP/PRP-T, reconstituted by pressing the plunger of the syringe immediately before injection, n = 239) or combined in a single-chamber syringe (C-In group, DTP@PRP-T, reconstituted immediately before injection, n = 61) or in separate injections (S-In group, DTP + PRP-T, simultaneously injected at separate sites, n = 237) at 3, 4, and 5 months of age. Serum samples were collected before vaccination and at 6 months of age. In the D-Ch group, the incidence of adverse events was comparable to administration of DTP vaccine alone. Higher rates of local and systemic reactions were observed in the Chilean population, possibly due to differences in surveillance practice. The immune response to each vaccine component compared well to that of the separate administration of PRP-T and DTP vaccines, except for higher post-immunization anti-PRP geometric mean titre (GMT) values after separate injections (25.6 micrograms mL-1) than after combined injection with the dual-chamber syringe (17.6 micrograms mL-1) (p = 0.001). An unexpected 'syringe' effect was seen: a greater post-immunization anti-PRP GMT was observed in the D-Ch group (17.6 micrograms mL-1) than in the C-In group (7.7 micrograms mL-1) (p = 0.0001). Whereas pre-immunization GMTs of some antibodies were significantly lower in Chilean than in Belgian infants, the post-immunization GMTs of Chilean infants were two to three times greater for all of the antibodies studied (p < 0.005). Differences in reactogenicity and in the immune response between the study populations or the different vaccine presentations were striking, but are probably of no clinical relevance. The convenient dual-chamber syringe presentation of DTP and PRP-T vaccines is safe and highly immunogenic.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">9682338</PMID><DateCompleted><Year>1998</Year><Month>10</Month><Day>09</Day></DateCompleted><DateRevised><Year>2019</Year><Month>07</Month><Day>28</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0264-410X</ISSN><JournalIssue CitedMedium="Print"><Volume>16</Volume><Issue>9-10</Issue><PubDate><MedlineDate>1998 May-Jun</MedlineDate></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Safety and immunogenicity of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine administered in a dual-chamber syringe to infants in Belgium and Chile.</ArticleTitle><Pagination><MedlinePgn>921-7</MedlinePgn></Pagination><Abstract><AbstractText>To document any unexpected differences in the immune response between study populations and to evaluate immunogenicity and safety of a simplified presentation (dual-chamber syringe) of an Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T) and diphtheria-tetanus-pertussis (DTP) combination vaccine, a multicentre, randomized, comparative study was conducted in Belgium and Chile. A total of 537 healthy infants, 270 in Chile and 267 in Belgium, received PRP-T and DTP vaccines combined in a dual-chamber syringe (D-Ch group, DTP/PRP-T, reconstituted by pressing the plunger of the syringe immediately before injection, n = 239) or combined in a single-chamber syringe (C-In group, DTP@PRP-T, reconstituted immediately before injection, n = 61) or in separate injections (S-In group, DTP + PRP-T, simultaneously injected at separate sites, n = 237) at 3, 4, and 5 months of age. Serum samples were collected before vaccination and at 6 months of age. In the D-Ch group, the incidence of adverse events was comparable to administration of DTP vaccine alone. Higher rates of local and systemic reactions were observed in the Chilean population, possibly due to differences in surveillance practice. The immune response to each vaccine component compared well to that of the separate administration of PRP-T and DTP vaccines, except for higher post-immunization anti-PRP geometric mean titre (GMT) values after separate injections (25.6 micrograms mL-1) than after combined injection with the dual-chamber syringe (17.6 micrograms mL-1) (p = 0.001). An unexpected 'syringe' effect was seen: a greater post-immunization anti-PRP GMT was observed in the D-Ch group (17.6 micrograms mL-1) than in the C-In group (7.7 micrograms mL-1) (p = 0.0001). Whereas pre-immunization GMTs of some antibodies were significantly lower in Chilean than in Belgian infants, the post-immunization GMTs of Chilean infants were two to three times greater for all of the antibodies studied (p < 0.005). Differences in reactogenicity and in the immune response between the study populations or the different vaccine presentations were striking, but are probably of no clinical relevance. The convenient dual-chamber syringe presentation of DTP and PRP-T vaccines is safe and highly immunogenic.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Hoppenbrouwers</LastName><ForeName>K</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Youth Health Care, Katholieke Universiteit Leuven, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lagos</LastName><ForeName>R</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Swennen</LastName><ForeName>B</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Ethevenaux</LastName><ForeName>C</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Knops</LastName><ForeName>J</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Levine</LastName><ForeName>M M</ForeName><Initials>MM</Initials></Author><Author ValidYN="Y"><LastName>Desmyter</LastName><ForeName>J</ForeName><Initials>J</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000907">Antibodies, Bacterial</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015721">Diphtheria-Tetanus-Pertussis Vaccine</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018073">Haemophilus Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C055753">Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013745">Tetanus Toxoid</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018074">Vaccines, Conjugate</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000907" MajorTopicYN="N">Antibodies, Bacterial</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001530" MajorTopicYN="N" Type="Geographic">Belgium</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002677" MajorTopicYN="N" Type="Geographic">Chile</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015721" MajorTopicYN="N">Diphtheria-Tetanus-Pertussis Vaccine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018073" MajorTopicYN="N">Haemophilus Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007115" MajorTopicYN="N">Immunization Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012449" MajorTopicYN="N">Safety</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013594" MajorTopicYN="N">Syringes</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013745" MajorTopicYN="N">Tetanus Toxoid</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018074" MajorTopicYN="N">Vaccines, Conjugate</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>1998</Year><Month>7</Month><Day>31</Day></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>1998</Year><Month>7</Month><Day>31</Day><Hour>0</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>1998</Year><Month>7</Month><Day>31</Day><Hour>0</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">9682338</ArticleId><ArticleId IdType="pii">S0264-410X(97)00303-4</ArticleId><ArticleId IdType="doi">10.1016/s0264-410x(97)00303-4</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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