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Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
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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
Abstract [en]

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.
Keyword [en]
Pneumococcal conjugate vaccine, PHiD-CV, pneumococcal disease, safety, reactogenicity, adverse events, children, infants, clinical trial, post-licensure
National Category
Immunology in the medical area
Identifiers
URN: urn:nbn:se:umu:diva-132132DOI: 10.1586/14760584.2016.1164044ISI: 000392988900004PubMedID: 26954689OAI: oai:DiVA.org:umu-132132DiVA: diva2:1079697
Available from: 2017-03-09 Created: 2017-03-09 Last updated: 2017-03-09Bibliographically approved

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CiteExportLink to record
Permanent link

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Citation style
  • apa
  • harvard1
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
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  • text
  • asciidoc
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