Diez-Domingo, Javierde Martino, MaurizioGarcia-Sicilia Lopez, JoseZuccotti, Gian VincenzoIcardi, GiancarloVillani, AlbertoMoreno-Perez, DavidMéndez Hernández, MaríaÁlvarez Aldeán, JavierMateen, Ahmed AbdulEnweonye, Igwebuikede Rooij, RichardChandra, Richa2017-05-262017-05-262016-08Diez-Domingo J, de Martino M, Lopez JG, Zuccotti GV, Icardi G, Villani A, et al. Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications. Int. J. Infect. Dis. 2016 ; 49:171-81201-9712http://hdl.handle.net/10668/2676Journal Article;BACKGROUND This descriptive, non-comparative, phase III study evaluated the safety and tolerability of cell culture-derived (TIVc) and egg-derived (TIV) seasonal influenza vaccines in children at risk of influenza-related complications. METHODS Four hundred and thirty subjects were randomized 2:1 to TIVc or TIV. Subjects aged 3 to <9 years received one dose (if previously vaccinated, n=89) or two doses (if not previously vaccinated, n=124) of the study vaccines; the 9 to <18-year-olds (n=213) received one dose. Reactogenicity was assessed for 7 days after vaccination; safety was monitored for 6 months. RESULTS After any vaccination, the most frequently reported solicited local adverse event (AE) was tenderness/pain (TIVc 44%, 66%, 53% and TIV 56%, 51%, 65% in the age groups 3 to <6 years, 6 to <9 years, and 9 to <18 years, respectively) and the systemic AE was irritability (22% TIVc, 24% TIV) in 3 to <6-year-olds and headache in 6 to <9-year-olds (20% TIVc, 13% TIV) and 9 to <18-year-olds (21% TIVc, 26% TIV). There were no cases of severe fever (≥40°C). No vaccine-related serious AEs were noted. New onset of chronic disease was reported in ≤1% of subjects. CONCLUSION TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).enSafetyCell culture-derivedInfluenza vaccineAt-risk childrenVacunas contra la InfluenzaNiñoAdolescenteVacunaciónHumanosPreescolarEstaciones del añoMedical Subject Headings::Chemicals and Drugs::Complex Mixtures::Biological Agents::Vaccines::Viral Vaccines::Influenza VaccinesMedical Subject Headings::Named Groups::Persons::Age Groups::ChildMedical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza, HumanMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::VaccinationMedical Subject Headings::Check Tags::MaleMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Health Care::Environment and Public Health::Environment::Meteorological Concepts::Atmosphere::Climate::Seasonsresearch article27343983open access10.1016/j.ijid.2016.06.0181878-3511