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Pediatr Infect Dis J ; 30(11): e216-24, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21747321

RESUMEN

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.


Asunto(s)
Cápsulas Bacterianas/administración & dosificación , Infecciones por Haemophilus/prevención & control , Vacunas contra Haemophilus/administración & dosificación , Haemophilus influenzae tipo b/inmunología , Enfermedades del Prematuro/prevención & control , Infecciones Meningocócicas/prevención & control , Vacunas Meningococicas/administración & dosificación , Neisseria meningitidis Serogrupo C/inmunología , Vacunación , Vacunas Combinadas/administración & dosificación , Anticuerpos Antibacterianos/sangre , Anticuerpos Antibacterianos/inmunología , Cápsulas Bacterianas/inmunología , Estudios de Casos y Controles , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Femenino , Infecciones por Haemophilus/sangre , Infecciones por Haemophilus/inmunología , Infecciones por Haemophilus/microbiología , Vacunas contra Haemophilus/inmunología , Hepatitis B/sangre , Hepatitis B/inmunología , Hepatitis B/prevención & control , Hepatitis B/virología , Humanos , Esquemas de Inmunización , Inmunización Secundaria , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/sangre , Enfermedades del Prematuro/inmunología , Enfermedades del Prematuro/microbiología , Enfermedades del Prematuro/virología , Masculino , Infecciones Meningocócicas/sangre , Infecciones Meningocócicas/inmunología , Infecciones Meningocócicas/microbiología , Vacunas Meningococicas/inmunología , Poliomielitis/sangre , Poliomielitis/inmunología , Poliomielitis/prevención & control , Poliomielitis/virología , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna Antipolio de Virus Inactivados/inmunología , España , Vacunas Combinadas/inmunología
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