AzTrials
AzTrials

Influenza, HumanPhase 2NCT04494412

An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection

A Phase 2 study testing Zanamivir in people with Influenza, Human and Arthralgia, run by GlaxoSmithKline at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages Up to 6 months
Conditions the study is for
Influenza, Human, Arthralgia
What is being tested?
Zanamivir
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
6 sitesin 3 countries
Study dates
21 Nov 2022to 1 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Neonates and infants who are aged less than 6 months (corrected age) at the time of the informed consent signed by legally acceptable representative (LAR) of minors. Preterm neonates and infants will be eligible for inclusion but must have reached PMA of at least 28 weeks.
  • Participants who are hospitalized with influenza infection, confirmed by a positive rapid molecular diagnostic test for influenza, or a local quantitative Reverse transcriptase-polymerase chain reaction (RT-PCR) test and who must have a potential for improvement Participants with negative rapid molecular test result suspected of having influenza can be enrolled following confirmatory testing by quantitative RT-PCR.
  • Participants with a high risk of altered oral drug absorption, represented by multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the treating physician). (applicable only for Netherlands)
  • Body weight >=1 kilograms (kg).
  • No gender restriction.
  • LAR of minors are willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, Independent Ethics Committees [IECs] or local laws).

Who cannot join

  • 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 (ALT) >=3 times upper limit of normal (ULN) with bilirubin >=2 times ULN
  • or isolated bilirubin >=2 times ULN and >50 percent (%) direct bilirubin
Show all 15Show fewer
  • or ALT >=5 times ULN Inclusion of participants with liver function tests that fall outside these criteria must be discussed and agreed with the medical monitor.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of benign conditions such as Gilbert's syndrome). Inclusion of participants with neonatal hyperbilirubinemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor (Not-applicable for Great Britain).
  • Participants who require concurrent therapy with another anti influenza drug.
  • Participants who have participated in a study using an investigational drug within 30 days prior to Baseline.
  • Child in care (CiC), as defined below:
  • A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
  • The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
  • Participants undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration.
  • Participants who are positive for severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) as determined by a diagnostic test, at screening

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Italy3 sites

  • GSK Investigational Site

    Florence, 50139

  • GSK Investigational Site

    Messina

  • GSK Investigational Site

    Roma, 00165

Other trials in Italy

Spain2 sites

  • GSK Investigational Site

    Barcelona, 08950

  • GSK Investigational Site

    Madrid, 28046

Other trials in Spain

Poland1 site

  • GSK Investigational Site

    Bydgoszcz, 85-168

Other trials in Poland

About this study

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

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.

Being tested
Zanamivir
Keywords
Human influenza, Zanamivir, Pediatric, Hospitalized neonates and infants
Medical subject headings
Influenza, Human, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanamivirDrug

    Also called DECTOVA

    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.

Study groups in NCT04494412
Study groupRoleWhat they receive
Hospitalized neonates and infants with influenza infectionExperimentalPreterm neonates and infants who have reached Post-Menstrual Age (PMA) of at least 28 weeks and have a confirmed complicated influenza infection will be included. Participants will receive daily IV infusion of zanamivir for up to 5 days. This initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests warrant further treatment. The initial dose of IV zanamivir will be determined by PMA/corrected age and body weight. The maintenance dose and interval between the initial dose and subsequent twice-daily maintenance dose will be further determined by Principal Investigator based on renal function.
Receives: Drug: Zanamivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the serum concentration-time curve (AUC) of zanamivir

    Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.

    Measured: Up to 12 hours after end of infusion on Day 1

  2. Maximum observed serum concentration (Cmax) of zanamivir

    Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.

    Measured: Up to 12 hours after end of infusion on Day 1

  3. Clearance (CL) in plasma following administration of zanamivir

    Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.

    Measured: 30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5

  4. Terminal half-life (t1/2) of zanamivir

    Blood samples will be collected at indicated time points for pharmacokinetic analysis of zanamivir.

    Measured: 30 minutes, 2 hours, 6 hours, 12 hours post dose on Day 1; predose on Days 3, 4 or 5

Secondary outcomes (10)

  1. 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.

    Measured: From start of treatment (Day 1) up to Day 24

  2. Number of participants with abnormal findings in heart rate

    Number of participants with abnormal findings for heart rate will be assessed.

    Measured: From start of treatment (Day 1) up to Day 24

  3. Number of participants with abnormal findings in Oxygen Saturation

    Number of participants with abnormal findings for Oxygen Saturation will be assessed.

    Measured: From start of treatment (Day 1) up to Day 24

  4. Number of participants with abnormal findings in respiration rate

    Number of participants with abnormal findings for respiration rate will be assessed.

    Measured: From start of treatment (Day 1) up to Day 24

  5. Number of participants with abnormal findings in body temperature

    Number of participants with abnormal findings for body temperature will be assessed.

    Measured: From start of treatment (Day 1) up to Day 24

  6. Viral load over time after administration of zanamivir

    Nasopharyngeal swab samples will be collected for assessing quantitative viral load.

    Measured: Day 1 up to Maximum Day 24

  7. Change From Baseline in viral load after administration of zanamivir

    Nasopharyngeal swab samples will be collected for assessing quantitative viral load.

    Measured: Baseline (Day 1) and up to maximum Day 24

  8. Number of participants with phenotypic resistance

    Nasopharyngeal swab samples will be collected for assessing phenotypic resistance.

    Measured: Up to Day 24

  9. Number of participants with genotypic resistance

    Nasopharyngeal swab samples will be collected for assessing genotypic resistance.

    Measured: Up to Day 24

  10. Number of participants with emergence of resistance to zanamivir

    Nucleotide sequence analysis will be carried out to determine emergence of resistance to zanamivir.

    Measured: Up to Day 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2020
  2. Study start21 Nov 2022
  3. Primary completion14 Jan 2026
  4. Study completion1 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, multi-center and single arm study
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04494412
Sponsor's protocol ID
200925
Status last verified
Jul 2026
First submitted
15 Jul 2020
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanamivir in people with Influenza, Human and Arthralgia, run by GlaxoSmithKline at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the serum concentration-time curve (AUC) of zanamivir (time frame: Up to 12 hours after end of infusion on Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04494412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in