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A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV

NCT06102174 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-30

Study results available
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Summary

The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. These children have Lower Respiratory Tract Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection to the lower airways such as lungs.

This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children.

This study is seeking for participants who:

* Are 1 day to less than or equal to 60 months of age
* weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms.
* Have been tested to have RSV by medical tests.
* show signs of LRTI.

All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it.

Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home.

The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

Placebo

Placebo

DRUG

Active

Sisunatovir

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-09-03
Completion
2024-09-03
FDA Drug
Yes

Countries

  • United States
  • Japan
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06102174 on ClinicalTrials.gov