Safety and Immunogenicity of a Pentavalent Vaccine Compared With Separate Administration of Licensed Equivalent Vaccines in US Infants and Toddlers and Persistence of Antibodies Before a Preschool Booster Dose: A Randomized, Clinical Trial

Our goal was to compare the safety and immunogenicity of a combination vaccine (DTaP(5)-IPV-Hib; Pentacel) with that of its separately administered, US-licensed equivalent vaccines (diphtheria, tetanus, 5-component acellular pertussis vaccine [DTaP(5); Daptacel], inactivated poliovirus vaccine [IPV;...

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Veröffentlicht in:Pediatrics (Evanston) 2009-01, Vol.123 (1), p.301-312
Hauptverfasser: Guerra, Fernando A, Blatter, Mark M, Greenberg, David P, Pichichero, Michael, Noriega, Fernando R, on behalf of Pentacel Study Group
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container_end_page 312
container_issue 1
container_start_page 301
container_title Pediatrics (Evanston)
container_volume 123
creator Guerra, Fernando A
Blatter, Mark M
Greenberg, David P
Pichichero, Michael
Noriega, Fernando R
on behalf of Pentacel Study Group
description Our goal was to compare the safety and immunogenicity of a combination vaccine (DTaP(5)-IPV-Hib; Pentacel) with that of its separately administered, US-licensed equivalent vaccines (diphtheria, tetanus, 5-component acellular pertussis vaccine [DTaP(5); Daptacel], inactivated poliovirus vaccine [IPV; IPOL], and Haemophilus influenzae type b [Hib] vaccine [ActHIB]), when administered to infants and toddlers concomitantly with other routinely recommended vaccines and to assess antibody persistence from the fourth dose in toddlers to the fifth (preschool) DTaP(5) dose. In this randomized, multicenter study, 1939 healthy infants were immunized at 2, 4, and 6 months of age with 1 of 3 lots of DTaP(5) coadministered with IPV and Hib vaccines or 1 lot of DTaP(5)-IPV-Hib combination vaccine. Subsequently, 849 of these study participants were given a fourth dose of DTaP(5) and Hib vaccines or a fourth dose of DTaP(5)-IPV-Hib at 1 to 16 months of age. Safety was monitored throughout the study, and blood specimens were obtained to assess antibody responses. DTaP(5)-IPV-Hib elicited similar or fewer solicited injection-site and systemic reactions as compared with the separate administration of US-licensed DTaP(5), IPV, and Hib vaccines. Seroresponse and seroprotection rates elicited by DTaP(5)-IPV-Hib were noninferior to US-licensed equivalent vaccines after the infant series and after the fourth dose. Children immunized with DTaP(5)-IPV-Hib had higher antibody geometric mean concentrations to pertussis toxoid and filamentous hemagglutinin; children immunized with the separate vaccines had higher responses to pertactin. Hib antibody responses to Hib polysaccharide were nearly identical in the DTaP(5)-IPV-Hib and separate-vaccine groups. Persistence of antibodies to the fifth (preschool) dose was also similar between groups. DTaP(5)-IPV-Hib combination vaccine was shown to be immunogenic and well tolerated. No clinically important differences in the safety or immunologic profiles were noted for DTaP(5)-IPV-Hib versus the separately administered, US-licensed equivalent vaccines. DTaP(5)-IPV-Hib is a suitable replacement for separately administered DTaP, IPV, and Hib vaccines.
doi_str_mv 10.1542/peds.2007-3317
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In this randomized, multicenter study, 1939 healthy infants were immunized at 2, 4, and 6 months of age with 1 of 3 lots of DTaP(5) coadministered with IPV and Hib vaccines or 1 lot of DTaP(5)-IPV-Hib combination vaccine. Subsequently, 849 of these study participants were given a fourth dose of DTaP(5) and Hib vaccines or a fourth dose of DTaP(5)-IPV-Hib at 1 to 16 months of age. Safety was monitored throughout the study, and blood specimens were obtained to assess antibody responses. DTaP(5)-IPV-Hib elicited similar or fewer solicited injection-site and systemic reactions as compared with the separate administration of US-licensed DTaP(5), IPV, and Hib vaccines. Seroresponse and seroprotection rates elicited by DTaP(5)-IPV-Hib were noninferior to US-licensed equivalent vaccines after the infant series and after the fourth dose. 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In this randomized, multicenter study, 1939 healthy infants were immunized at 2, 4, and 6 months of age with 1 of 3 lots of DTaP(5) coadministered with IPV and Hib vaccines or 1 lot of DTaP(5)-IPV-Hib combination vaccine. Subsequently, 849 of these study participants were given a fourth dose of DTaP(5) and Hib vaccines or a fourth dose of DTaP(5)-IPV-Hib at 1 to 16 months of age. Safety was monitored throughout the study, and blood specimens were obtained to assess antibody responses. DTaP(5)-IPV-Hib elicited similar or fewer solicited injection-site and systemic reactions as compared with the separate administration of US-licensed DTaP(5), IPV, and Hib vaccines. Seroresponse and seroprotection rates elicited by DTaP(5)-IPV-Hib were noninferior to US-licensed equivalent vaccines after the infant series and after the fourth dose. Children immunized with DTaP(5)-IPV-Hib had higher antibody geometric mean concentrations to pertussis toxoid and filamentous hemagglutinin; children immunized with the separate vaccines had higher responses to pertactin. Hib antibody responses to Hib polysaccharide were nearly identical in the DTaP(5)-IPV-Hib and separate-vaccine groups. Persistence of antibodies to the fifth (preschool) dose was also similar between groups. DTaP(5)-IPV-Hib combination vaccine was shown to be immunogenic and well tolerated. No clinically important differences in the safety or immunologic profiles were noted for DTaP(5)-IPV-Hib versus the separately administered, US-licensed equivalent vaccines. DTaP(5)-IPV-Hib is a suitable replacement for separately administered DTaP, IPV, and Hib vaccines.</description><subject>Antibodies</subject><subject>Antibodies, Bacterial - biosynthesis</subject><subject>Antibodies, Bacterial - blood</subject><subject>Antibodies, Viral - biosynthesis</subject><subject>Antibodies, Viral - blood</subject><subject>Bacterial diseases</subject><subject>Bacterial diseases of the nervous system. Bacterial myositis</subject><subject>Bacterial Vaccines - administration &amp; dosage</subject><subject>Bacterial Vaccines - adverse effects</subject><subject>Bacterial Vaccines - pharmacokinetics</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical trials</subject><subject>Comparative analysis</subject><subject>Demographic aspects</subject><subject>Diphtheria-Tetanus-acellular Pertussis Vaccines - administration &amp; dosage</subject><subject>Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects</subject><subject>Diphtheria-Tetanus-acellular Pertussis Vaccines - pharmacokinetics</subject><subject>Diphtheria-Tetanus-Pertussis Vaccine</subject><subject>Dosage and administration</subject><subject>Ent and stomatologic bacterial diseases</subject><subject>Female</subject><subject>General aspects</subject><subject>Haemophilus Vaccines</subject><subject>Hib vaccines</subject><subject>Human bacterial diseases</subject><subject>Humans</subject><subject>Immunization Schedule</subject><subject>Immunization, Secondary - adverse effects</subject><subject>Immunization, Secondary - methods</subject><subject>Infant</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pediatrics</subject><subject>Pertussis vaccines</subject><subject>Physiological aspects</subject><subject>Poliovirus Vaccine, Inactivated - administration &amp; dosage</subject><subject>Poliovirus Vaccine, Inactivated - adverse effects</subject><subject>Poliovirus Vaccine, Inactivated - pharmacokinetics</subject><subject>Safety</subject><subject>Therapeutic Equivalency</subject><subject>United States</subject><subject>Vaccines</subject><subject>Vaccines, Combined - administration &amp; dosage</subject><subject>Vaccines, Combined - adverse effects</subject><subject>Vaccines, Combined - pharmacokinetics</subject><subject>Vaccines, Conjugate - administration &amp; dosage</subject><subject>Vaccines, Conjugate - adverse effects</subject><subject>Vaccines, Conjugate - metabolism</subject><subject>Viral antibodies</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkk1vEzEQhlcIREPhyhFZSHBigz_3o7c0FIgUqRVJ4Wh57dnE1a6d2hug_Gn-Al4SUeDkGeuZd16N3ix7TvCUCE7f7sDEKcW4zBkj5YNsQnBd5ZyW4mE2wZiRnGMsTrInMd5gjLko6ePshNSElFVdTLKfK9XCcIeUM2jR93vnN-CstunLt0ihK3CD-qq69KDPSmvrAM19v1MBDPpihy1aQWrUAGhmeutsHFJjvRvHl1aDiwm8uN3bf0Uisg5dr9DCtcoN8ff-tTemg3BorlKRxMBpGKVmbrCNNzYNnkPrA4zeAkS99b5D594nNKB3PsIZmqFPScH39geYN2jeJVdadWgdrOqeZo9a1UV4dnxPs-v3F-v5x3x5-WExny1znW435AQ3WJGaCiAlFpUWoFnLCRFKiVoo03BhNGaGtmVNqcCVaSrOq1YVjSmKpmCn2euD7i742z3EQfY2aug65cDvoyyKsmKc4wS-_A-88fvgkjdJacUELylJUH6ANumI0jrt3QDfB-27DjYgk_P5pZyRmhFc8IolfnrgdfAxBmjlLthehTtJsBxzI8fcyDE3csxNGnhxdLFvejD3-DEoCXh1BFRMx2yDctrGPxxNGKtpeb95azfbbzbAuMmqIVgd_yoJZZJIhgn7Bcgq3oE</recordid><startdate>20090101</startdate><enddate>20090101</enddate><creator>Guerra, Fernando A</creator><creator>Blatter, Mark M</creator><creator>Greenberg, David P</creator><creator>Pichichero, Michael</creator><creator>Noriega, Fernando R</creator><creator>on behalf of Pentacel Study Group</creator><general>Am Acad Pediatrics</general><general>American Academy of Pediatrics</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>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>U9A</scope><scope>7X8</scope></search><sort><creationdate>20090101</creationdate><title>Safety and Immunogenicity of a Pentavalent Vaccine Compared With Separate Administration of Licensed Equivalent Vaccines in US Infants and Toddlers and Persistence of Antibodies Before a Preschool Booster Dose: A Randomized, Clinical Trial</title><author>Guerra, Fernando A ; Blatter, Mark M ; Greenberg, David P ; Pichichero, Michael ; Noriega, Fernando R ; on behalf of Pentacel Study Group</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c427t-10b0a1925e17058c5ec3f4115aa595adb45dc03d2f7922508db8448fa6bd66b63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Antibodies</topic><topic>Antibodies, Bacterial - biosynthesis</topic><topic>Antibodies, Bacterial - blood</topic><topic>Antibodies, Viral - biosynthesis</topic><topic>Antibodies, Viral - blood</topic><topic>Bacterial diseases</topic><topic>Bacterial diseases of the nervous system. 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In this randomized, multicenter study, 1939 healthy infants were immunized at 2, 4, and 6 months of age with 1 of 3 lots of DTaP(5) coadministered with IPV and Hib vaccines or 1 lot of DTaP(5)-IPV-Hib combination vaccine. Subsequently, 849 of these study participants were given a fourth dose of DTaP(5) and Hib vaccines or a fourth dose of DTaP(5)-IPV-Hib at 1 to 16 months of age. Safety was monitored throughout the study, and blood specimens were obtained to assess antibody responses. DTaP(5)-IPV-Hib elicited similar or fewer solicited injection-site and systemic reactions as compared with the separate administration of US-licensed DTaP(5), IPV, and Hib vaccines. Seroresponse and seroprotection rates elicited by DTaP(5)-IPV-Hib were noninferior to US-licensed equivalent vaccines after the infant series and after the fourth dose. Children immunized with DTaP(5)-IPV-Hib had higher antibody geometric mean concentrations to pertussis toxoid and filamentous hemagglutinin; children immunized with the separate vaccines had higher responses to pertactin. Hib antibody responses to Hib polysaccharide were nearly identical in the DTaP(5)-IPV-Hib and separate-vaccine groups. Persistence of antibodies to the fifth (preschool) dose was also similar between groups. DTaP(5)-IPV-Hib combination vaccine was shown to be immunogenic and well tolerated. No clinically important differences in the safety or immunologic profiles were noted for DTaP(5)-IPV-Hib versus the separately administered, US-licensed equivalent vaccines. DTaP(5)-IPV-Hib is a suitable replacement for separately administered DTaP, IPV, and Hib vaccines.</abstract><cop>Elk Grove Village, IL</cop><pub>Am Acad Pediatrics</pub><pmid>19117896</pmid><doi>10.1542/peds.2007-3317</doi><tpages>12</tpages></addata></record>
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1098-4275
language eng
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source MEDLINE; EZB-FREE-00999 freely available EZB journals
subjects Antibodies
Antibodies, Bacterial - biosynthesis
Antibodies, Bacterial - blood
Antibodies, Viral - biosynthesis
Antibodies, Viral - blood
Bacterial diseases
Bacterial diseases of the nervous system. Bacterial myositis
Bacterial Vaccines - administration & dosage
Bacterial Vaccines - adverse effects
Bacterial Vaccines - pharmacokinetics
Biological and medical sciences
Child
Child, Preschool
Clinical trials
Comparative analysis
Demographic aspects
Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage
Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects
Diphtheria-Tetanus-acellular Pertussis Vaccines - pharmacokinetics
Diphtheria-Tetanus-Pertussis Vaccine
Dosage and administration
Ent and stomatologic bacterial diseases
Female
General aspects
Haemophilus Vaccines
Hib vaccines
Human bacterial diseases
Humans
Immunization Schedule
Immunization, Secondary - adverse effects
Immunization, Secondary - methods
Infant
Infectious diseases
Male
Medical sciences
Pediatrics
Pertussis vaccines
Physiological aspects
Poliovirus Vaccine, Inactivated - administration & dosage
Poliovirus Vaccine, Inactivated - adverse effects
Poliovirus Vaccine, Inactivated - pharmacokinetics
Safety
Therapeutic Equivalency
United States
Vaccines
Vaccines, Combined - administration & dosage
Vaccines, Combined - adverse effects
Vaccines, Combined - pharmacokinetics
Vaccines, Conjugate - administration & dosage
Vaccines, Conjugate - adverse effects
Vaccines, Conjugate - metabolism
Viral antibodies
title Safety and Immunogenicity of a Pentavalent Vaccine Compared With Separate Administration of Licensed Equivalent Vaccines in US Infants and Toddlers and Persistence of Antibodies Before a Preschool Booster Dose: A Randomized, Clinical Trial
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