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An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection
Sponsor: GlaxoSmithKline
Summary
Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD), safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants more than or equal to (\>=) 6 months of age with hospitalized influenza in the IV zanamivir global development program. However, antiviral treatment of neonates and infants under 6 months of age hospitalized with influenza infection remains a medical unmet need. Given the immaturity of the immune system at this age, there are no licensed influenza vaccines for children aged less than six months old. As a requirement of the Pediatric Investigation Plan European Union (EU), GlaxoSmithKline (GSK) will be conducting this open-label, multi-center, single arm, post-marketing authorization study to evaluate the PK and collect safety and tolerability information of IV zanamivir in hospitalized neonates and infants under 6 months of age with confirmed complicated influenza infection. The total duration of study participation for each participant will be up to 24 days with a study treatment period up to 10 days and 14 days of post-treatment follow up. However, for a given participant, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests as assessed by the investigator warrant further treatment. DECTOVA is a trademark of GlaxoSmithKline group of companies.
Official title: An Open Label, Single Arm Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety and Tolerability, and to Explore Clinical Outcomes of Treatment With Intravenous (IV) Zanamivir in Neonates and Infants Under 6 Months of Age With Confirmed Complicated Influenza Infection
Key Details
Gender
All
Age Range
Any - 6 Months
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2022-11-21
Completion Date
2026-04-30
Last Updated
2025-03-17
Healthy Volunteers
No
Conditions
Interventions
Zanamivir
Zanamivir solution for infusion will be available as a 10 milligrams per milliliters (mg/mL) vial. DECTOVA is approved for age groups 6 months and above.
Locations (9)
GSK Investigational Site
Florence, Italy
GSK Investigational Site
Messina, Italy
GSK Investigational Site
Milan, Italy
GSK Investigational Site
Roma, Italy
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom