At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Zanamivir (drug)
- How long the study runs
- Study runs about 41 months (dates as stated)
- About the drug or intervention
- Zanamivir — drug: Zanamivir solution for infusion will be available as a 10 milligrams per milliliters (mg/mL) vial.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- Up to 6 Months
- Who
- All
- Number of participants
- 8
- Started
- 2022-11-21
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for influenza, human
- • Phase2 - 8 participants
- • Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality
Who can take part?
- • Ages Up to 6 Months
- • Diagnosed with influenza, human
Where?
- • No UK sites listed for this trial
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 6 Months
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ reached PMA of at least 28 weeks
What the study is looking for
- ✓Body weight \>=1 kilograms (kg).
- ✓No gender restriction.
Who cannot take part
- ✗Participants who are known or suspected to be hypersensitive to any component of the study medication.
- ✗Participants with a disease process which is likely to be irreversible.
- ✗Liver function:
- ✗Participants who meet the following criteria at Baseline:
- ✗Alanine transaminase (liver enzymes) \>=3 times upper limit of normal (ULN) with liver blood test \>=2 times ULN
