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Pediatr Infect Dis J ; 30(11): e216-24, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-21747321

RESUMO

BACKGROUND: Preterm infants are at greater risk of morbidity from vaccine-preventable diseases. Therefore, their responses to vaccination are of particular interest. METHODS: In this open, controlled, Spanish multicenter study, we assessed immunogenicity and safety following primary vaccination of 163 preterm infants (n = 56, <31 weeks' gestation; n = 107, 31-36 weeks' gestation) and 150 full-term infants (>36 weeks' gestation), with Haemophilus Influenzae type B (Hib)-MenC-TT, DTaP(diphtheria-tetanus-acellular pertussis vaccine)-HepB-IPV, and PCV7 at 2 to 4-6 months of age followed by booster vaccination at 16 to 18 months of age. Serum bactericidal activity (rabbit complement) against MenC, and antibodies to Hib and hepatitis b (anti-HBs) were determined. Local/general symptoms were assessed after each vaccination via diary cards. Serious adverse events were recorded throughout the study. RESULTS: There were no statistically significant differences between preterm and full-term infants in either Hib or MenC seroprotection rates or geometric mean concentrations at 1 month postdose 3, before or 1 month postbooster. Postdose 3, >99% of participants had seroprotective anti-HBs antibody concentrations. Anti-HBs geometric mean concentrations was significantly lower in the <31-week group compared with other groups and this difference persisted until 16 to 18 months of age. Hib-MenC-TT vaccine was well tolerated at all ages. There was one death caused by meningococcal serogroup-B sepsis (full term). No serious adverse events were assessed by the investigator as being vaccine related. CONCLUSIONS: Hib-MenC-TT vaccine had a similar immunogenicity and safety profile in preterm and full-term infants. These results demonstrate that preterm infants can be safely vaccinated with Hib-MenC-TT at the recommended chronologic age without impacting the responses to the Hib and MenC antigens.


Assuntos
Cápsulas Bacterianas/administração & dosagem , Infecções por Haemophilus/prevenção & controle , Vacinas Anti-Haemophilus/administração & dosagem , Haemophilus influenzae tipo b/imunologia , Doenças do Prematuro/prevenção & controle , Infecções Meningocócicas/prevenção & controle , Vacinas Meningocócicas/administração & dosagem , Neisseria meningitidis Sorogrupo C/imunologia , Vacinação , Vacinas Combinadas/administração & dosagem , Anticorpos Antibacterianos/sangue , Anticorpos Antibacterianos/imunologia , Cápsulas Bacterianas/imunologia , Estudos de Casos e Controles , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Feminino , Infecções por Haemophilus/sangue , Infecções por Haemophilus/imunologia , Infecções por Haemophilus/microbiologia , Vacinas Anti-Haemophilus/imunologia , Hepatite B/sangue , Hepatite B/imunologia , Hepatite B/prevenção & controle , Hepatite B/virologia , Humanos , Esquemas de Imunização , Imunização Secundária , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/sangue , Doenças do Prematuro/imunologia , Doenças do Prematuro/microbiologia , Doenças do Prematuro/virologia , Masculino , Infecções Meningocócicas/sangue , Infecções Meningocócicas/imunologia , Infecções Meningocócicas/microbiologia , Vacinas Meningocócicas/imunologia , Poliomielite/sangue , Poliomielite/imunologia , Poliomielite/prevenção & controle , Poliomielite/virologia , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio de Vírus Inativado/imunologia , Espanha , Vacinas Combinadas/imunologia
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