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Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program
To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes. Follow-up of a cohort of 21,064 infants (20,925 or 99.7% adhered to the...
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Published in: | Jornal de pediatria 2007-11, Vol.83 (6), p.523-528 |
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creator | Martins, Reinaldo M Camacho, Luiz A B Lemos, Maria Cristina F Noronha, Tatiana G de Carvalho, Maria Helena C de Greffe, Nadja da Silva, Marli M Périssé, André R Maia, Maria Lourdes S Homma, Akira |
description | To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes.
Follow-up of a cohort of 21,064 infants (20,925 or 99.7% adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only.
The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine.
The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications. |
doi_str_mv | 10.2223/JPED.1721 |
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Follow-up of a cohort of 21,064 infants (20,925 or 99.7% adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only.
The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine.
The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.</description><identifier>ISSN: 0021-7557</identifier><identifier>DOI: 10.2223/JPED.1721</identifier><identifier>PMID: 18074056</identifier><language>eng</language><publisher>Brazil</publisher><subject><![CDATA[Brazil - epidemiology ; Cohort Studies ; Diphtheria - prevention & control ; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage ; Diphtheria-Tetanus-Pertussis Vaccine - adverse effects ; Female ; Fever - epidemiology ; Fever - etiology ; Haemophilus Infections - prevention & control ; Haemophilus Vaccines - administration & dosage ; Haemophilus Vaccines - adverse effects ; Humans ; Immunization Programs - statistics & numerical data ; Incidence ; Infant ; Interviews as Topic ; Male ; Seizures - epidemiology ; Seizures - etiology ; Severity of Illness Index ; Tetanus - prevention & control ; Whooping Cough - prevention & control]]></subject><ispartof>Jornal de pediatria, 2007-11, Vol.83 (6), p.523-528</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c248t-2a2f021ce499451e680f5a51b281e96398989a695a752713102c2414d10ffd493</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18074056$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Martins, Reinaldo M</creatorcontrib><creatorcontrib>Camacho, Luiz A B</creatorcontrib><creatorcontrib>Lemos, Maria Cristina F</creatorcontrib><creatorcontrib>Noronha, Tatiana G de</creatorcontrib><creatorcontrib>Carvalho, Maria Helena C de</creatorcontrib><creatorcontrib>Greffe, Nadja</creatorcontrib><creatorcontrib>da Silva, Marli M</creatorcontrib><creatorcontrib>Périssé, André R</creatorcontrib><creatorcontrib>Maia, Maria Lourdes S</creatorcontrib><creatorcontrib>Homma, Akira</creatorcontrib><title>Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program</title><title>Jornal de pediatria</title><addtitle>J Pediatr (Rio J)</addtitle><description>To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes.
Follow-up of a cohort of 21,064 infants (20,925 or 99.7% adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only.
The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine.
The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.</description><subject>Brazil - epidemiology</subject><subject>Cohort Studies</subject><subject>Diphtheria - prevention & control</subject><subject>Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage</subject><subject>Diphtheria-Tetanus-Pertussis Vaccine - adverse effects</subject><subject>Female</subject><subject>Fever - epidemiology</subject><subject>Fever - etiology</subject><subject>Haemophilus Infections - prevention & control</subject><subject>Haemophilus Vaccines - administration & dosage</subject><subject>Haemophilus Vaccines - adverse effects</subject><subject>Humans</subject><subject>Immunization Programs - statistics & numerical data</subject><subject>Incidence</subject><subject>Infant</subject><subject>Interviews as Topic</subject><subject>Male</subject><subject>Seizures - epidemiology</subject><subject>Seizures - etiology</subject><subject>Severity of Illness Index</subject><subject>Tetanus - prevention & control</subject><subject>Whooping Cough - prevention & control</subject><issn>0021-7557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><recordid>eNpFkE1OwzAQhb0A0VJYcAHkFRKLtLbz6yXQQosq6KKsI8eZUKPEDnZSqT0Cp8alldAsZt7ozZPmQ-iGkjFjLJy8rmbTMU0ZPUNDQhgN0jhOB-jSuS9C4oQn9AINaEbSyKsh-lloqUrQErCp8GbXms5oJYPDZMG1Rju1BQytcqYEh4VzRirRQYk7g7sNYGmaQmmvp-vVZK4KvBVS-gXunV8qjR-t2KtaCY3fRKeMFjVeNE2v1f5POryy5tOK5gqdV6J2cH3qI_TxPFs_zYPl-8vi6WEZSBZlXcAEq_xfEiLOo5hCkpEqFjEtWEaBJyHPfImExyKNWUpDSpg_pFFJSVWVEQ9H6O6Y21rz3YPr8kY5CXUtNJje5QknCfd4vPH-aJTWOGehylurGmF3OSX5AXZ-gJ0fYHvv7Sm0Lxoo_50n0uEvYtp9Mw</recordid><startdate>20071101</startdate><enddate>20071101</enddate><creator>Martins, Reinaldo M</creator><creator>Camacho, Luiz A B</creator><creator>Lemos, Maria Cristina F</creator><creator>Noronha, Tatiana G de</creator><creator>Carvalho, Maria Helena C de</creator><creator>Greffe, Nadja</creator><creator>da Silva, Marli M</creator><creator>Périssé, André R</creator><creator>Maia, Maria Lourdes S</creator><creator>Homma, Akira</creator><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>7X8</scope></search><sort><creationdate>20071101</creationdate><title>Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program</title><author>Martins, Reinaldo M ; Camacho, Luiz A B ; Lemos, Maria Cristina F ; Noronha, Tatiana G de ; Carvalho, Maria Helena C de ; Greffe, Nadja ; da Silva, Marli M ; Périssé, André R ; Maia, Maria Lourdes S ; Homma, Akira</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c248t-2a2f021ce499451e680f5a51b281e96398989a695a752713102c2414d10ffd493</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Brazil - epidemiology</topic><topic>Cohort Studies</topic><topic>Diphtheria - prevention & control</topic><topic>Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage</topic><topic>Diphtheria-Tetanus-Pertussis Vaccine - adverse effects</topic><topic>Female</topic><topic>Fever - epidemiology</topic><topic>Fever - etiology</topic><topic>Haemophilus Infections - prevention & control</topic><topic>Haemophilus Vaccines - administration & dosage</topic><topic>Haemophilus Vaccines - adverse effects</topic><topic>Humans</topic><topic>Immunization Programs - statistics & numerical data</topic><topic>Incidence</topic><topic>Infant</topic><topic>Interviews as Topic</topic><topic>Male</topic><topic>Seizures - epidemiology</topic><topic>Seizures - etiology</topic><topic>Severity of Illness Index</topic><topic>Tetanus - prevention & control</topic><topic>Whooping Cough - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Martins, Reinaldo M</creatorcontrib><creatorcontrib>Camacho, Luiz A B</creatorcontrib><creatorcontrib>Lemos, Maria Cristina F</creatorcontrib><creatorcontrib>Noronha, Tatiana G de</creatorcontrib><creatorcontrib>Carvalho, Maria Helena C de</creatorcontrib><creatorcontrib>Greffe, Nadja</creatorcontrib><creatorcontrib>da Silva, Marli M</creatorcontrib><creatorcontrib>Périssé, André R</creatorcontrib><creatorcontrib>Maia, Maria Lourdes S</creatorcontrib><creatorcontrib>Homma, Akira</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Jornal de pediatria</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Martins, Reinaldo M</au><au>Camacho, Luiz A B</au><au>Lemos, Maria Cristina F</au><au>Noronha, Tatiana G de</au><au>Carvalho, Maria Helena C de</au><au>Greffe, Nadja</au><au>da Silva, Marli M</au><au>Périssé, André R</au><au>Maia, Maria Lourdes S</au><au>Homma, Akira</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program</atitle><jtitle>Jornal de pediatria</jtitle><addtitle>J Pediatr (Rio J)</addtitle><date>2007-11-01</date><risdate>2007</risdate><volume>83</volume><issue>6</issue><spage>523</spage><epage>528</epage><pages>523-528</pages><issn>0021-7557</issn><abstract>To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes.
Follow-up of a cohort of 21,064 infants (20,925 or 99.7% adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only.
The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine.
The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.</abstract><cop>Brazil</cop><pmid>18074056</pmid><doi>10.2223/JPED.1721</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Brazil - epidemiology Cohort Studies Diphtheria - prevention & control Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage Diphtheria-Tetanus-Pertussis Vaccine - adverse effects Female Fever - epidemiology Fever - etiology Haemophilus Infections - prevention & control Haemophilus Vaccines - administration & dosage Haemophilus Vaccines - adverse effects Humans Immunization Programs - statistics & numerical data Incidence Infant Interviews as Topic Male Seizures - epidemiology Seizures - etiology Severity of Illness Index Tetanus - prevention & control Whooping Cough - prevention & control |
title | Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program |
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