Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)
2017 (English)In: Expert Review of Vaccines, ISSN 1476-0584, E-ISSN 1744-8395, Vol. 16, no 2, 109-121 p.Article, review/survey (Refereed) Published
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.
Place, publisher, year, edition, pages
Taylor & Francis, 2017. Vol. 16, no 2, 109-121 p.
Pneumococcal conjugate vaccine, PHiD-CV, pneumococcal disease, safety, reactogenicity, adverse events, children, infants, clinical trial, post-licensure
Immunology in the medical area
IdentifiersURN: urn:nbn:se:umu:diva-132132DOI: 10.1586/14760584.2016.1164044ISI: 000392988900004PubMedID: 26954689OAI: oai:DiVA.org:umu-132132DiVA: diva2:1079697