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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504425-39-00 | Registry Identifier | CTIS (EU) |
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Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral or Nasogastric tube (NG) |
|
| Sisunatovir | Active Comparator | Oral or NG tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Active |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. All AEs were included for evaluation. | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| Number of Participants Who Discontinued From Study Due to TEAEs | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| Number of Participants Who Discontinued From Study Due to Serious TEAEs | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. A serious AE (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation if existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important event or situation as pre-specified in protocol. | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations Versus Time Summary of Sisunatovir | Day 3: Pre-dose, T1 and T2 hours post-dose; Day 5: Pre-dose; where T1 is the first analysis time point post-dose while T2 is the second analysis time point post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Los Angeles Medical center | Los Angeles | California | 90027 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41673909 | Derived | Toussi SS, Calvo C, Haumann B, Thomas E, Franke RM, Kudela M, Zhang S, Banerjee A, Rees S, Shoji S, Welch H, Jordan I, Srisingh K, Daud M, Nemeth A, Rojo P, Toh TH, Ogunade I, Oku S, Amo K, Towner W, Newland J, Alami NN. Safety and Pharmacokinetics of the RSV Fusion Inhibitor Sisunatovir Across Two Early-phase Studies in Infants and Children With RSV Lower Respiratory Tract Infection. Pediatr Infect Dis J. 2026 Aug 1;45(8):724-732. doi: 10.1097/INF.0000000000005169. Epub 2026 Feb 12. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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In this study, participants aged from 1 day to <=60 months received study intervention. Participants of Cohort 1A received study intervention at a low dose level and participants of Cohorts 1B and 1C received study treatment at high dose levels. Cohort 1A had participants of age category 1 (the lowest age category), cohort 1B had participants of age category 2 (medium age category) and cohort 1C had participants of age category 3 (the highest age category).
As per plan study was to have 3 cohorts: 1, 2, and 3. Cohorts 1 and 2 was to have further 4 sub-cohorts: A, B, C and D; and Cohort 3 to have sub-cohorts: B, D, E and F. However, due to early termination of study participants were enrolled only in Cohorts 1A, 1B and 1C. No participants were enrolled in Cohort 1D, Cohort 2, and in Cohort 3; hence no results are reported for them. All results are only pertaining to Cohorts 1A, 1B and 1C in this record.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1A: Sisunatovir | Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days. |
| FG001 | Cohort 1A: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2024 | Aug 25, 2025 |
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| Drug |
Sisunatovir |
|
|
| Number of Participants With Clinically Significant Laboratory Abnormalities | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, mean cell volume, mean cell hemoglobin & concentration); chemistry: urea and creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyl transferase (GGT), calcium, sodium, potassium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, total protein, cystatin C; urinalysis: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, albumin, creatinine (urine), urine albumin to creatinine ratio. Clinically significant laboratory abnormalities findings were based on investigator discretion. | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| Number of Participants With Clinically Significant Vital Signs | Vital signs included systolic and diastolic blood pressure, pulse rate/heart rate, temperature, respiratory rate, and oxygen saturation. Clinically significance vital signs findings were based on investigator discretion. | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| Los Angeles |
| California |
| 90027 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Kojunkai Daido Hospital | Nagoya | Aichi-ken | 457-8511 | Japan |
| Nintenkai Kagoshima Children's Hospital | Hioki | Kagoshima-ken | 899-2503 | Japan |
| Yamanashi Prefectural Central Hospital | Kofu | Yamanashi | 400-8506 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Monti Clinical Research Centre | Mdantsane | Eastern Cape | 5219 | South Africa |
| University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA) | Johannesburg | Gauteng | 2013 | South Africa |
Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days.
| FG002 | Cohort 1B: Sisunatovir | Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| FG003 | Cohort 1B: Placebo | Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| FG004 | Cohort 1C: Sisunatovir | Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| FG005 | Cohort 1C: Placebo | Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1A: Sisunatovir | Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days. |
| BG001 | Cohort 1A: Placebo | Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| BG002 | Cohort 1B: Sisunatovir | Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| BG003 | Cohort 1B: Placebo | Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| BG004 | Cohort 1C: Sisunatovir | Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| BG005 | Cohort 1C: Placebo | Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. All AEs were included for evaluation. | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued From Study Due to TEAEs | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued From Study Due to Serious TEAEs | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. A serious AE (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation if existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important event or situation as pre-specified in protocol. | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, mean cell volume, mean cell hemoglobin & concentration); chemistry: urea and creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyl transferase (GGT), calcium, sodium, potassium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, total protein, cystatin C; urinalysis: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, albumin, creatinine (urine), urine albumin to creatinine ratio. Clinically significant laboratory abnormalities findings were based on investigator discretion. | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Vital Signs | Vital signs included systolic and diastolic blood pressure, pulse rate/heart rate, temperature, respiratory rate, and oxygen saturation. Clinically significance vital signs findings were based on investigator discretion. | Safety population consisted of all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days) |
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| Secondary | Plasma Concentrations Versus Time Summary of Sisunatovir | Pharmacokinetic (PK) concentration set: all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 concentration value can be reported. "Number Analyzed": participants evaluable for specified timepoints, if its value is 0 it means data was missing, PK concentration was not collected at respective timepoint and arm. Data was analyzed and reported only for those arms where participants took sisunatovir, not for placebo arms. | Posted | Median | Full Range | Nanogram per milliliter | Day 3: Pre-dose, T1 and T2 hours post-dose; Day 5: Pre-dose; where T1 is the first analysis time point post-dose while T2 is the second analysis time point post-dose |
|
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1A: Sisunatovir | Participants of age category 1 were randomized and sisunatovir was administered at low dose level orally or via nasogastric tube for 5 days. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Cohort 1A: Placebo | Participants of age category 1 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Cohort 1B: Sisunatovir | Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | Cohort 1B: Placebo | Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | Cohort 1C: Sisunatovir | Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | Cohort 1C: Placebo | Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. | 0 | 2 | 0 | 2 | 1 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
|
Sponsor decided to maintain company confidentiality, hence dose strengths, dose frequency, and PK sampling time points have not been disclosed in the record.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2025 | Aug 25, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C000717948 | sisunatovir |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Cohort 1B: Placebo | Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| OG004 | Cohort 1C: Sisunatovir | Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| OG005 | Cohort 1C: Placebo | Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
|
|
| OG002 | Cohort 1B: Sisunatovir | Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| OG003 | Cohort 1B: Placebo | Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| OG004 | Cohort 1C: Sisunatovir | Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| OG005 | Cohort 1C: Placebo | Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
|
|
| OG002 | Cohort 1B: Sisunatovir | Participants of age category 2 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| OG003 | Cohort 1B: Placebo | Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| OG004 | Cohort 1C: Sisunatovir | Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| OG005 | Cohort 1C: Placebo | Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
|
|
| OG003 |
| Cohort 1B: Placebo |
Participants of age category 2 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
| OG004 | Cohort 1C: Sisunatovir | Participants of age category 3 were randomized and sisunatovir was administered at high dose level orally or via nasogastric tube for 5 days. |
| OG005 | Cohort 1C: Placebo | Participants of age category 3 were randomized and placebo matched to sisunatovir was administered orally or via nasogastric tube for 5 days. |
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