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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Glaxosmithkline Research & Development Limited

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

29 Jan 2021 → 2 Apr 2026

Decision date (initial)

2024-10-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-510663-34-00

EudraCT number

2019-001588-63

ClinicalTrials.gov

NCT04494412

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To characterise single and multiple dose to steady state pharmacokinetics of IV zanamivir in hospitalised neonates and infants under 6 months of age with influenza infection

Conditions and MedDRA coding

Influenza, Human

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-001318-PIP01-12

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age. 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 Post-Menstrual Age (PMA) of at least 28 weeks.
2. Participants who are hospitalised with influenza infection, confirmed by a positive rapid molecular diagnostic test for influenza, or a local quantitative RT-PCR test and who must have a potential for improvement. Subjects with negative rapid molecular test result suspected of having influenza can be enrolled following confirmatory testing by quantitative RT-PCR.
3. Weight. Body weight ≥1kg.
4. Sex. Male or female.
5. Informed Consent Legally acceptable representative (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, IECs or local laws).

Exclusion criteria 8

1. Participants who are known or suspected to be hypersensitive to any component of the study medication.
2. Participants who, in the judgment of the investigator, are unlikely to complete the course of treatment due to their current disease process.
3. Liver function: • Subjects who meet the following criteria at Baseline: ALT ≥3xULN with Bilirubin ≥2xULN or Isolated bilirubin ≥ 2xULN and >50% direct bilirubin or ALT ≥5xULN Inclusion of subjects 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 subjects with neonatal hyperbilirubinaemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor.
4. Participants who require concurrent therapy with another anti influenza drug.
5. Participants who have participated in a study using an investigational drug within 30 days prior to Baseline.
6. Child in care (CiC), as defined below: • A child who has been placed under the control or protection of an agency, organisation, 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.
7. Patients undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration.
8. Participants who are positive for SARS-CoV-2, as determined by a diagnostic test, at screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Area under the serum concentration-time curve (AUC)
2. Maximum serum concentration (Cmax)
3. Clearance (CL)
4. Terminal half-life (t1/2)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Glaxosmithkline Research & Development Limited

Sponsor organisation

Glaxosmithkline Research & Development Limited

Address

G S K House, 980 Great West Road 980 Great West Road

City

Brentford

Postcode

TW8 9GS

Country

United Kingdom

Scientific contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Third parties 4

Locations

2 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications