Downloads provided by UsageCountsSafety 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
Copyright policy ) Diez Domingo, Javier; de Martino, Maurizio; Lopez, Jose Garcia Sicilia; Zuccotti, Gian Vincenzo; ICARDI, GIANCARLO; Villani, Alberto; Moreno Perez, David; +6 Authors
Diez Domingo, Javier; de Martino, Maurizio; Lopez, Jose Garcia Sicilia; Zuccotti, Gian Vincenzo; ICARDI, GIANCARLO; Villani, Alberto; Moreno Perez, David; Hernández, María Méndez; Aldeán, Javier Álvarez; Mateen, Ahmed Abdul; Enweonye, Igwebuike; de Rooij, Richard; Chandra, Richa;
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
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.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.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.TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).
- Novartis (Canada) Canada
- University of Milan Italy
- Hospital Materno-Infantil Spain
- Novartis (United States) United States
- New York University Italy
Microbiology (medical), Male, Adolescent, Cell culture-derived, Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccination, Infectious and parasitic diseases, RC109-216, Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans, Influenza, Human, Humans, At-risk children, Child, At-risk children; Cell culture-derived; Influenza vaccine; Safety, Influenza vaccine, Vaccination, Medical Subject Headings::Named Groups::Persons::Age Groups::Child, Medical Subject Headings::Check Tags::Female, Medical Subject Headings::Check Tags::Male, Infectious Diseases, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Medical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza, Human, Influenza Vaccines, at-risk children; cell culture-derived; Influenza vaccine; safety, Medical Subject Headings::Chemicals and Drugs::Complex Mixtures::Biological Agents::Vaccines::Viral Vaccines::Influenza Vaccines, Child, Preschool, Medical Subject Headings::Health Care::Environment and Public Health::Environment::Meteorological Concepts::Atmosphere::Climate::Seasons, Female, Safety
Microbiology (medical), Male, Adolescent, Cell culture-derived, Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccination, Infectious and parasitic diseases, RC109-216, Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans, Influenza, Human, Humans, At-risk children, Child, At-risk children; Cell culture-derived; Influenza vaccine; Safety, Influenza vaccine, Vaccination, Medical Subject Headings::Named Groups::Persons::Age Groups::Child, Medical Subject Headings::Check Tags::Female, Medical Subject Headings::Check Tags::Male, Infectious Diseases, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Medical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza, Human, Influenza Vaccines, at-risk children; cell culture-derived; Influenza vaccine; safety, Medical Subject Headings::Chemicals and Drugs::Complex Mixtures::Biological Agents::Vaccines::Viral Vaccines::Influenza Vaccines, Child, Preschool, Medical Subject Headings::Health Care::Environment and Public Health::Environment::Meteorological Concepts::Atmosphere::Climate::Seasons, Female, Safety
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