title: Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children.
abstract: The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, Synflorix™) were assessed in 240 healthy Chilean children randomized to receive 3 doses of PHiD-CV (PHiD-CV group) or hepatitis A vaccine (HAV control group) at 2-4-6 months of age. All were offered 1 HAV dose at 12 months (outside study). The PHiD-CV group received a second HAV dose at 18-21 months and PHiD-CV booster at 20-23 months. The HAV control group received 2 PHiD-CV catch-up doses at 18-21 and 20-23 months. Adverse events were recorded and pneumococcal antibody responses and opsonophagocytic activity (OPA) were measured. Both PHiD-CV vaccination schedules were well tolerated and immunogenic against the pneumococcal vaccine serotypes and protein D. The reactogenicity of PHiD-CV primary, booster and catch-up doses was in line with previous PHiD-CV studies, although generally higher than with HAV. For each vaccine serotype, the percentage of subjects with antibody concentrations ≥0.2 µg/ml (GSK's 22F-inhibition ELISA) was at least 93.2% following 3 PHiD-CV primary doses and at least 97.4% post-booster; percentages with OPA titers ≥8 were at least 91.7% post-booster. After 2-dose catch-up, at least 94.3% of children had antibody concentrations ≥0.2 µg/ml against each serotype except 6B (84.3%); at least 95.2% had OPA titers ≥8 except against serotypes 1, 5 and 6B. In conclusion, the safety profiles of 2 PHiD-CV vaccination schedules (3-dose primary plus booster and 2-dose catch-up) were in line with previous studies and PHiD-CV was immunogenic for all 10 vaccine serotypes and protein D.
authors: Centro para Vacunas en Desarrollo-Chile, Santiago, Chile.
authors: Rosanna E
authors: RE
authors: Lagos
authors: Alma E
authors: AE
authors: Muñoz
authors: Myron M
authors: MM
authors: Levine
authors: Alejandro
authors: A
authors: Lepetic
authors: Nancy
authors: N
authors: François
authors: Juan Pablo
authors: JP
authors: Yarzabal
authors: Lode
authors: L
authors: Schuerman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D002675:Child, Preschool; D002677:Chile / Q000453:epidemiology; D005260:Female; D006192:Haemophilus Infections / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D007223:Infant; D008297:Male; D011008:Pneumococcal Infections / Q000453:epidemiology* / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000379:methods
chemical_list: D000907:Antibodies, Bacterial; C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines