title: Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan.
abstract: OBJECTIVE
  The immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae (H. Influenzae) protein D conjugate vaccine (PHiD-CV), co-administered with routine childhood vaccines, were assessed in Taiwanese infants.
  
  
  METHODS
  In this open study, 230 healthy infants were primed with three doses of PHiD-CV (Synflorix) and diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-HBV-IPV/Hib vaccine) at 1.5, 3 and 6 months of age and two doses of oral human rotavirus vaccine at 1.5 and 3 months. Pneumococcal immune responses were assessed 1 month post-dose three, by 22F-inhibition ELISA and opsonophagocytic activity (OPA) assay. Local and general solicited/unsolicited symptoms and serious adverse events (SAEs) were recorded.
  
  
  RESULTS
  At least 95.4% of participants had an antibody concentration ≥ 0.2 μg/mL against each vaccine serotype. At least 96.1% of participants had an OPA titer ≥ 8 against each vaccine serotype except 6B (87.3%). All infants, but one, were seropositive for antibodies against nontypeable H. influenzae protein D. Immune responses to the co-administered vaccines were good and in line with previous reports. PHiD-CV was well tolerated, with low (≤ 6.3%) incidences of grade 3 solicited local symptoms. The frequencies of general symptoms were in line with other pneumococcal conjugate vaccine studies. There were no systematic increases in incidences of solicited general or local symptoms with successive doses. There were no reports of grade 3 fever (rectal temperature > 40 °C) or SAEs considered to be causally related to vaccination.
  
  
  CONCLUSIONS
  PHiD-CV co-administered with routine childhood vaccines within the first 6 months of life, was highly immunogenic, and well tolerated in Taiwanese infants.
authors.affiliation: Chang Gung Children's Hospital, Chang Gung University College of Medicine, Taiwan.
authors.forename: Tzou-Yien
authors.initials: TY
authors.lastname: Lin
authors.forename: Chun-Yi
authors.initials: CY
authors.lastname: Lu
authors.forename: Luan-Yin
authors.initials: LY
authors.lastname: Chang
authors.forename: Cheng-Hsun
authors.initials: CH
authors.lastname: Chiu
authors.forename: Yhu-Chering
authors.initials: YC
authors.lastname: Huang
authors.forename: Hans L
authors.initials: HL
authors.lastname: Bock
authors.forename: Haiwen
authors.initials: H
authors.lastname: Tang
authors.forename: Nancy
authors.initials: N
authors.lastname: François
authors.forename: Marta
authors.initials: M
authors.lastname: Moreira
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Huang
mesh_terms: D016667:Bacterial Capsules / Q000276:immunology*; D006192:Haemophilus Infections / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006193:Haemophilus influenzae / Q000276:immunology*; D006801:Humans; D007223:Infant; D011008:Pneumococcal Infections / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D013296:Streptococcus pneumoniae; D013624:Taiwan; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: C538863:10-valent pneumococcal vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate