title: Combined Haemophilus Influenzae type B-Neisseria meningitidis serogroup C vaccine is immunogenic and well tolerated in preterm infants when coadministered with other routinely recommended vaccines.
abstract: 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.
authors: Hospital La Paz, Serv. Neonatología, Madrid, Spain. fomenaca.hulp@salud.madrid.org
authors: Félix
authors: F
authors: Omeñaca
authors: Javier
authors: J
authors: Arístegui
authors: Juan Carlos
authors: JC
authors: Tejedor
authors: David
authors: D
authors: Moreno-Perez
authors: Jésus
authors: J
authors: Ruiz-Contreras
authors: Jose Manuel
authors: JM
authors: Merino
authors: Marta
authors: M
authors: Muro Brussi
authors: Tomás
authors: T
authors: Sánchez-Tamayo
authors: Javier
authors: J
authors: Castro Fernandez
authors: Lucia
authors: L
authors: Cabanillas
authors: Kavitha
authors: K
authors: Peddiraju
authors: Narcisa
authors: N
authors: Mesaros
authors: Jacqueline M
authors: JM
authors: Miller
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D016667:Bacterial Capsules / Q000008:administration & dosage* / Q000276:immunology; D016022:Case-Control Studies; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000276:immunology; D005260:Female; D006192:Haemophilus Infections / Q000097:blood / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000276:immunology; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006509:Hepatitis B / Q000097:blood / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000097:blood / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008589:Meningococcal Infections / Q000097:blood / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D011051:Poliomyelitis / Q000097:blood / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000276:immunology; D013030:Spain; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D022401:Meningococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined