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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
GSK Investigational Site
Florence, Italy
GSK Investigational Site
Messina, Italy
GSK Investigational Site
Roma, Italy
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Madrid, Spain
Area under the serum concentration-time curve (AUC) of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame: Up to 12 hours after end of infusion on Day 1
Maximum observed serum concentration (Cmax) of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame: Up to 12 hours after end of infusion on Day 1
Clearance (CL) in plasma following administration of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame: 30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5
Terminal half-life (t1/2) of zanamivir
Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.
Time frame: 30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5
Number of participants with adverse event(s) (AE) and serious adverse event(s) (SAE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect or any other important medical event that may jeopardize the participant or may require medical or surgical treatment to prevent one of the other outcomes listed before.
Time frame: From start of treatment (Day 1) up to Day 24
Number of participants with abnormal findings in heart rate
Number of participants with abnormal findings for heart rate will be assessed.
Time frame: From start of treatment (Day 1) up to Day 24
Number of participants with abnormal findings in Oxygen Saturation
Number of participants with abnormal findings for Oxygen Saturation will be assessed.
Time frame: From start of treatment (Day 1) up to Day 24
Number of participants with abnormal findings in respiration rate
Number of participants with abnormal findings for respiration rate will be assessed.
Time frame: From start of treatment (Day 1) up to Day 24
Number of participants with abnormal findings in body temperature
Number of participants with abnormal findings for body temperature will be assessed.
Time frame: From start of treatment (Day 1) up to Day 24
Viral load over time after administration of zanamivir
Nasopharyngeal swab samples will be collected for assessing quantitative viral load.
Time frame: Day 1 up to Maximum Day 24
Change From Baseline in viral load after administration of zanamivir
Nasopharyngeal swab samples will be collected for assessing quantitative viral load.
Time frame: Baseline (Day 1) and up to maximum Day 24
Number of participants with phenotypic resistance
Nasopharyngeal swab samples will be collected for assessing phenotypic resistance.
Time frame: Up to Day 24
Number of participants with genotypic resistance
Nasopharyngeal swab samples will be collected for assessing genotypic resistance.
Time frame: Up to Day 24
Number of participants with emergence of resistance to zanamivir
Nucleotide sequence analysis will be carried out to determine emergence of resistance to zanamivir.
Time frame: Up to Day 24
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