Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2–11 years in Malaysia: A randomized, placebo-controlled, Phase III study

Highlights • We evaluate a Phase III production lot of a candidate dengue vaccine (CYD-TDV). • CYD-TDV demonstrates a satisfactory safety profile in children. • CYD-TDV demonstrates a balanced immune response against all dengue virus serotypes.

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Bibliographische Detailangaben
Veröffentlicht in:	Vaccine 2013-12, Vol.31 (49), p.5814-5821
Hauptverfasser:	HSS, Amar-Singh, Koh, Mia-Tuang, Tan, Kah Kee, Chan, Lee Gaik, Zhou, Lynn, Bouckenooghe, Alain, Crevat, Denis, Hutagalung, Yanee
Format:	Artikel
Sprache:	eng
Schlagworte:	Age Allergy and Immunology Antibodies, Neutralizing - blood Antibodies, Viral - blood Applied microbiology Arboviroses Biological and medical sciences Child Child, Preschool children Confidence intervals Cross Protection dengue Dengue - prevention & control Dengue fevers Dengue Vaccines - adverse effects Dengue Vaccines - therapeutic use Dengue virus Female Fundamental and applied biological sciences. Psychology Human viral diseases Humans humoral immunity Immune response Immunity, Humoral Immunization Schedule Immunogenicity Infections Infectious diseases Malaysia Male Medical sciences Microbiology neutralizing antibodies Paediatric population Public health Safety seroprevalence serotypes Single-Blind Method Suggestions dengue Tropical viral diseases Vaccination - adverse effects Vaccine Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vector-borne diseases Viral diseases Voice recognition
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Beschreibung
Zusammenfassung:	Highlights • We evaluate a Phase III production lot of a candidate dengue vaccine (CYD-TDV). • CYD-TDV demonstrates a satisfactory safety profile in children. • CYD-TDV demonstrates a balanced immune response against all dengue virus serotypes.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2013.10.013