title: Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV).
abstract: Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile.
authors.affiliation: a Department of Clinical Sciences, Pediatrics , Umeå University , Umeå , Sweden.
authors.forename: Sven Arne
authors.initials: SA
authors.lastname: Silfverdal
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Coremans
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Nancy
authors.initials: N
authors.lastname: François
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Dorota
authors.initials: D
authors.lastname: Borys
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Cleerbout
mesh_terms: D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D006192:Haemophilus Infections / Q000517:prevention & control; D006801:Humans; D011008:Pneumococcal Infections / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies
chemical_list: C547294:PHiD-CV vaccine; D022242:Pneumococcal Vaccines
keywords: PHiD-CV; Pneumococcal conjugate vaccine; adverse events; children; clinical trial; infants; pneumococcal disease; post-licensure; reactogenicity; safety