Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX HB™ in healthy infants
Background: In a previous clinical trial comparing COMVAX™ with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™, one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COM...
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| Veröffentlicht in: | Vaccine 2002-12, Vol.21 (3), p.181-187 |
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| creator | Kaplan, Karen M Rusche, Steven A Lakkis, Hassan D Bottenfield, Gerald Guerra, Fernando A Guerrero, Juan Keyserling, Harry Felicione, Elise Hesley, Teresa M Boslego, John W |
| description | Background: In a previous clinical trial comparing COMVAX™ with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™, one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COMVAX™ compared with two monovalent control vaccines. Rates of prolonged crying were similar between groups at each visit.
Objectives: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX™ plus placebo and recipients of PedvaxHIB™ plus RECOMBIVAX HB™ following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit.
Design: We enrolled 1215 healthy infants in a randomized, double blind, placebo-controlled study. Participating infants received study vaccines at 2 and 4 months of age and other routine childhood vaccines at 6–7 weeks and 3 months of age. Crying was evaluated via questionnaire at the time of enrollment (baseline) and daily from days 0 to 2 after each injection.
Results: Reports of unusual, high-pitched crying and prolonged crying were uncommon ( |
| doi_str_mv | 10.1016/S0264-410X(02)00469-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_72715898</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0264410X02004693</els_id><sourcerecordid>72715898</sourcerecordid><originalsourceid>FETCH-LOGICAL-c483t-ed6426b8c047fb1a712914af289a44096758fea6c5ce6388a6399094ce7d9fc83</originalsourceid><addsrcrecordid>eNqF0k1uEzEUB_ARAtFQOALIEgKVxYDt8XjsFWqjQiIVteJL3VmO503iamIHeyaQPSfhBJyJk-BJApFY0JUt-_es9-R_lj0m-CXBhL_6gClnOSP4-gTTFxgzLvPiTjYioipyWhJxNxv9JUfZgxhvMMZlQeT97IhQVmIu6Sj7eeVjl7fWgIt9AGT8cqWD7uwaUOz6eoN8g3rXx163aGHni3xlO7OAGpmwsW6OtKvRKvjWu_nhsPFt678Ou_Hlu8-n17--_9jBVhuYebSGEPuIrqBe62-T6dmf-_fnyZ9NUwWabA-tQwvQbbfYpG2jXRcfZvca3UZ4tF-Ps09vzj-OJ_nF5dvp-PQiN0wUXQ41Z5TPhMGsamZEV4RKwnRDhdSMYcmrUjSguSkN8EIIzQspsWQGqlo2RhTH2fPdu2m4Lz3ETi1tNNC22oHvo6poRUohb4dE8BIXskjw5P-wxLiquGQ80af_0BvfB5fmVYSlNqvhA5Mqd8oEH2OARq2CXeqwUQSrISRqGxI1JEBhqrYhUUMjT_av97Ml1IeqfSoSeLYHOhrdNkE7Y-PBMUwJEyy51zsH6SPWFoKKxoIzUNsAplO1t7e08htRuNwk</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1490971245</pqid></control><display><type>article</type><title>Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX HB™ in healthy infants</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><source>ProQuest Central UK/Ireland</source><creator>Kaplan, Karen M ; Rusche, Steven A ; Lakkis, Hassan D ; Bottenfield, Gerald ; Guerra, Fernando A ; Guerrero, Juan ; Keyserling, Harry ; Felicione, Elise ; Hesley, Teresa M ; Boslego, John W</creator><creatorcontrib>Kaplan, Karen M ; Rusche, Steven A ; Lakkis, Hassan D ; Bottenfield, Gerald ; Guerra, Fernando A ; Guerrero, Juan ; Keyserling, Harry ; Felicione, Elise ; Hesley, Teresa M ; Boslego, John W</creatorcontrib><description>Background: In a previous clinical trial comparing COMVAX™ with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™, one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COMVAX™ compared with two monovalent control vaccines. Rates of prolonged crying were similar between groups at each visit.
Objectives: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX™ plus placebo and recipients of PedvaxHIB™ plus RECOMBIVAX HB™ following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit.
Design: We enrolled 1215 healthy infants in a randomized, double blind, placebo-controlled study. Participating infants received study vaccines at 2 and 4 months of age and other routine childhood vaccines at 6–7 weeks and 3 months of age. Crying was evaluated via questionnaire at the time of enrollment (baseline) and daily from days 0 to 2 after each injection.
Results: Reports of unusual, high-pitched crying and prolonged crying were uncommon (<1%) prior to the first vaccination visit and were comparable in both treatment groups. After each injection, rates of unusual, high-pitched crying (range: 4.26–6.96%) and prolonged crying (range: 0–1.36%) appeared similar between treatment groups and for each vaccination visit. Crying resolved in all infants; no neurological impairment was reported.
Conclusion: This study found no statistically significant differences in rates of unusual, high-pitched crying and prolonged crying in infants vaccinated with COMVAX™ plus placebo compared with infants vaccinated with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/S0264-410X(02)00469-3</identifier><identifier>PMID: 12450692</identifier><identifier>CODEN: VACCDE</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject><![CDATA[Age ; Bacterial Outer Membrane Proteins - administration & dosage ; Bacteriology ; Biological and medical sciences ; Clinical trials ; Comparative studies ; Confidence intervals ; Crying ; Double-Blind Method ; Fundamental and applied biological sciences. Psychology ; Haemophilus Vaccines - administration & dosage ; Hepatitis ; Hepatitis B Vaccines - administration & dosage ; Humans ; Immunization ; Immunization Schedule ; Infant ; Infants ; Injection ; Licenses ; Microbiology ; Polysaccharides, Bacterial - administration & dosage ; Prolonged crying ; Safety ; Tetanus ; Unusual high-pitched crying ; Vaccination - adverse effects ; Vaccination - psychology ; Vaccine safety ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies ; Vaccines, Combined - administration & dosage ; Vaccines, Synthetic - administration & dosage ; Virology]]></subject><ispartof>Vaccine, 2002-12, Vol.21 (3), p.181-187</ispartof><rights>2002 Elsevier Science Ltd</rights><rights>2003 INIST-CNRS</rights><rights>Copyright Elsevier Limited Dec 13, 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c483t-ed6426b8c047fb1a712914af289a44096758fea6c5ce6388a6399094ce7d9fc83</citedby><cites>FETCH-LOGICAL-c483t-ed6426b8c047fb1a712914af289a44096758fea6c5ce6388a6399094ce7d9fc83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1490971245?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,64361,64363,64365,65309,72215</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14021484$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12450692$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kaplan, Karen M</creatorcontrib><creatorcontrib>Rusche, Steven A</creatorcontrib><creatorcontrib>Lakkis, Hassan D</creatorcontrib><creatorcontrib>Bottenfield, Gerald</creatorcontrib><creatorcontrib>Guerra, Fernando A</creatorcontrib><creatorcontrib>Guerrero, Juan</creatorcontrib><creatorcontrib>Keyserling, Harry</creatorcontrib><creatorcontrib>Felicione, Elise</creatorcontrib><creatorcontrib>Hesley, Teresa M</creatorcontrib><creatorcontrib>Boslego, John W</creatorcontrib><title>Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX HB™ in healthy infants</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Background: In a previous clinical trial comparing COMVAX™ with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™, one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COMVAX™ compared with two monovalent control vaccines. Rates of prolonged crying were similar between groups at each visit.
Objectives: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX™ plus placebo and recipients of PedvaxHIB™ plus RECOMBIVAX HB™ following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit.
Design: We enrolled 1215 healthy infants in a randomized, double blind, placebo-controlled study. Participating infants received study vaccines at 2 and 4 months of age and other routine childhood vaccines at 6–7 weeks and 3 months of age. Crying was evaluated via questionnaire at the time of enrollment (baseline) and daily from days 0 to 2 after each injection.
Results: Reports of unusual, high-pitched crying and prolonged crying were uncommon (<1%) prior to the first vaccination visit and were comparable in both treatment groups. After each injection, rates of unusual, high-pitched crying (range: 4.26–6.96%) and prolonged crying (range: 0–1.36%) appeared similar between treatment groups and for each vaccination visit. Crying resolved in all infants; no neurological impairment was reported.
Conclusion: This study found no statistically significant differences in rates of unusual, high-pitched crying and prolonged crying in infants vaccinated with COMVAX™ plus placebo compared with infants vaccinated with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™.</description><subject>Age</subject><subject>Bacterial Outer Membrane Proteins - administration & dosage</subject><subject>Bacteriology</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Comparative studies</subject><subject>Confidence intervals</subject><subject>Crying</subject><subject>Double-Blind Method</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Haemophilus Vaccines - administration & dosage</subject><subject>Hepatitis</subject><subject>Hepatitis B Vaccines - administration & dosage</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunization Schedule</subject><subject>Infant</subject><subject>Infants</subject><subject>Injection</subject><subject>Licenses</subject><subject>Microbiology</subject><subject>Polysaccharides, Bacterial - administration & dosage</subject><subject>Prolonged crying</subject><subject>Safety</subject><subject>Tetanus</subject><subject>Unusual high-pitched crying</subject><subject>Vaccination - adverse effects</subject><subject>Vaccination - psychology</subject><subject>Vaccine safety</subject><subject>Vaccines</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</subject><subject>Vaccines, Combined - administration & dosage</subject><subject>Vaccines, Synthetic - administration & dosage</subject><subject>Virology</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</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>eNqF0k1uEzEUB_ARAtFQOALIEgKVxYDt8XjsFWqjQiIVteJL3VmO503iamIHeyaQPSfhBJyJk-BJApFY0JUt-_es9-R_lj0m-CXBhL_6gClnOSP4-gTTFxgzLvPiTjYioipyWhJxNxv9JUfZgxhvMMZlQeT97IhQVmIu6Sj7eeVjl7fWgIt9AGT8cqWD7uwaUOz6eoN8g3rXx163aGHni3xlO7OAGpmwsW6OtKvRKvjWu_nhsPFt678Ou_Hlu8-n17--_9jBVhuYebSGEPuIrqBe62-T6dmf-_fnyZ9NUwWabA-tQwvQbbfYpG2jXRcfZvca3UZ4tF-Ps09vzj-OJ_nF5dvp-PQiN0wUXQ41Z5TPhMGsamZEV4RKwnRDhdSMYcmrUjSguSkN8EIIzQspsWQGqlo2RhTH2fPdu2m4Lz3ETi1tNNC22oHvo6poRUohb4dE8BIXskjw5P-wxLiquGQ80af_0BvfB5fmVYSlNqvhA5Mqd8oEH2OARq2CXeqwUQSrISRqGxI1JEBhqrYhUUMjT_av97Ml1IeqfSoSeLYHOhrdNkE7Y-PBMUwJEyy51zsH6SPWFoKKxoIzUNsAplO1t7e08htRuNwk</recordid><startdate>20021213</startdate><enddate>20021213</enddate><creator>Kaplan, Karen M</creator><creator>Rusche, Steven A</creator><creator>Lakkis, Hassan D</creator><creator>Bottenfield, Gerald</creator><creator>Guerra, Fernando A</creator><creator>Guerrero, Juan</creator><creator>Keyserling, Harry</creator><creator>Felicione, Elise</creator><creator>Hesley, Teresa M</creator><creator>Boslego, John W</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>20021213</creationdate><title>Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX HB™ in healthy infants</title><author>Kaplan, Karen M ; Rusche, Steven A ; Lakkis, Hassan D ; Bottenfield, Gerald ; Guerra, Fernando A ; Guerrero, Juan ; Keyserling, Harry ; Felicione, Elise ; Hesley, Teresa M ; Boslego, John W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c483t-ed6426b8c047fb1a712914af289a44096758fea6c5ce6388a6399094ce7d9fc83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Age</topic><topic>Bacterial Outer Membrane Proteins - administration & dosage</topic><topic>Bacteriology</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Comparative studies</topic><topic>Confidence intervals</topic><topic>Crying</topic><topic>Double-Blind Method</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Haemophilus Vaccines - administration & dosage</topic><topic>Hepatitis</topic><topic>Hepatitis B Vaccines - administration & dosage</topic><topic>Humans</topic><topic>Immunization</topic><topic>Immunization Schedule</topic><topic>Infant</topic><topic>Infants</topic><topic>Injection</topic><topic>Licenses</topic><topic>Microbiology</topic><topic>Polysaccharides, Bacterial - administration & dosage</topic><topic>Prolonged crying</topic><topic>Safety</topic><topic>Tetanus</topic><topic>Unusual high-pitched crying</topic><topic>Vaccination - adverse effects</topic><topic>Vaccination - psychology</topic><topic>Vaccine safety</topic><topic>Vaccines</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</topic><topic>Vaccines, Combined - administration & dosage</topic><topic>Vaccines, Synthetic - administration & dosage</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kaplan, Karen M</creatorcontrib><creatorcontrib>Rusche, Steven A</creatorcontrib><creatorcontrib>Lakkis, Hassan D</creatorcontrib><creatorcontrib>Bottenfield, Gerald</creatorcontrib><creatorcontrib>Guerra, Fernando A</creatorcontrib><creatorcontrib>Guerrero, Juan</creatorcontrib><creatorcontrib>Keyserling, Harry</creatorcontrib><creatorcontrib>Felicione, Elise</creatorcontrib><creatorcontrib>Hesley, Teresa M</creatorcontrib><creatorcontrib>Boslego, John W</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>Kaplan, Karen M</au><au>Rusche, Steven A</au><au>Lakkis, Hassan D</au><au>Bottenfield, Gerald</au><au>Guerra, Fernando A</au><au>Guerrero, Juan</au><au>Keyserling, Harry</au><au>Felicione, Elise</au><au>Hesley, Teresa M</au><au>Boslego, John W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX HB™ in healthy infants</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2002-12-13</date><risdate>2002</risdate><volume>21</volume><issue>3</issue><spage>181</spage><epage>187</epage><pages>181-187</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><coden>VACCDE</coden><abstract>Background: In a previous clinical trial comparing COMVAX™ with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™, one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COMVAX™ compared with two monovalent control vaccines. Rates of prolonged crying were similar between groups at each visit.
Objectives: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX™ plus placebo and recipients of PedvaxHIB™ plus RECOMBIVAX HB™ following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit.
Design: We enrolled 1215 healthy infants in a randomized, double blind, placebo-controlled study. Participating infants received study vaccines at 2 and 4 months of age and other routine childhood vaccines at 6–7 weeks and 3 months of age. Crying was evaluated via questionnaire at the time of enrollment (baseline) and daily from days 0 to 2 after each injection.
Results: Reports of unusual, high-pitched crying and prolonged crying were uncommon (<1%) prior to the first vaccination visit and were comparable in both treatment groups. After each injection, rates of unusual, high-pitched crying (range: 4.26–6.96%) and prolonged crying (range: 0–1.36%) appeared similar between treatment groups and for each vaccination visit. Crying resolved in all infants; no neurological impairment was reported.
Conclusion: This study found no statistically significant differences in rates of unusual, high-pitched crying and prolonged crying in infants vaccinated with COMVAX™ plus placebo compared with infants vaccinated with its monovalent components, PedvaxHIB™ and RECOMBIVAX HB™.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>12450692</pmid><doi>10.1016/S0264-410X(02)00469-3</doi><tpages>7</tpages></addata></record> |
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| ispartof | Vaccine, 2002-12, Vol.21 (3), p.181-187 |
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| language | eng |
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| subjects | Age Bacterial Outer Membrane Proteins - administration & dosage Bacteriology Biological and medical sciences Clinical trials Comparative studies Confidence intervals Crying Double-Blind Method Fundamental and applied biological sciences. Psychology Haemophilus Vaccines - administration & dosage Hepatitis Hepatitis B Vaccines - administration & dosage Humans Immunization Immunization Schedule Infant Infants Injection Licenses Microbiology Polysaccharides, Bacterial - administration & dosage Prolonged crying Safety Tetanus Unusual high-pitched crying Vaccination - adverse effects Vaccination - psychology Vaccine safety Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies Vaccines, Combined - administration & dosage Vaccines, Synthetic - administration & dosage Virology |
| title | Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX HB™ in healthy infants |
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