Clinical trial NCT04225897: A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
Official title: A Phase 2 Open-Label Study in Infants With REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebocontrolled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus (RSV)
Lower Resp Tract Infection
Keywords: RV521
Pediatrics
Children
LRTI
Wheezing
Rhinitis
Cough
sisunatovir
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI. Due to the adaptive study design, the number of enrolled subjects may vary depending on the obtained PK and safety profiles.

The clinical study consists of 3 parts:

* Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 \& 2)
* Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 \& 5)
* Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it.

This study will be conducted in 3 parts:

In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B.

The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo.

To participate in this study participants must meet the following criteria:

1. Age 1 month to 36 months
2. Weight ≥ 3.5 kg
3. Diagnosis of LRTI
4. Diagnosis of RSV
5. Hospitalization due to RSV LRTI

Detailed description: This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI.

The clinical study consists of 3 parts, the third part (Part C) is optional:

* Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 \& 2)
* Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 \& 5)
* Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI I The number of subjects enrolled in Parts A and B of the study will depend on the safety and PK data from the group of subjects enrolled in specified age cohorts and the subsequent recommendation of the Data Safety Monitoring Committee (DSMC).

The DSMC may recommend a dose adjustment (either a reduction or an escalation) and/or regimen adjustment (Part B only) for subsequent subjects because of the observation of an unexpected safety/tolerability profile and/or differences between the observed and predicted exposure resulting from a specified dose of RV521.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 1 month and ≤ 36 months of age
2. Weight ≥ 3.5 kg
3. Clinical diagnosis of LRTI
4. A positive RSV diagnostic test
5. Hospitalised because of RSV LRTI
6. Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit
7. Expected to remain in hospital for a minimum of 3 days
8. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol

Exclusion Criteria:

1. Premature (gestational age less than 37 weeks) AND \<1 year of post-natal age
2. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug.
3. Any clinically significant ECG abnormalities.
4. Known to be immunocompromised.
5. High risk of having developing asthma.
6. Suspected of having a clinically significant bacterial infection.
7. History of renal failure.
8. Clinical evidence of hepatic decompensation
9. History of epilepsy or seizures, including febrile seizures
10. Allergy to test medication or constituents
11. Has received 1 or more doses of palivizumab at any time before Screening or received treatment with antiviral therapy for RSV (eg, ribavirin or intravenous \[IV\] immunoglobulin) within 3 months before the Screening Visit.

Primary outcomes:
measure: Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
timeFrame: From start of IMP on Day 1 up to Day 7
measure: Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
timeFrame: From start of IMP on Day 1 up to Day 12
measure: Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose
timeFrame: Anytime between 18 to 24 hours post-dose on Day 1
measure: Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose
timeFrame: At 48 hours post-dose on Day 1
measure: Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10
timeFrame: Anytime between 40 to 48 hours post-dose 10 on Day 5
measure: Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
timeFrame: Anytime between 4 to 5 hours post-dose on Day 1
measure: Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose
timeFrame: At 12 hours post-dose on Day 1
measure: Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose
timeFrame: Anytime between 18 to 24 hours post-dose on Day 1
measure: Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose
timeFrame: 48 hours post-dose on Day 1
measure: Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
timeFrame: Anytime between 4 to 5 hours post-dose 1 (Day 1)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2
timeFrame: Pre-dose 2 (Day 1)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3
timeFrame: Pre-dose 3 (Day 2)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4
timeFrame: Pre-dose 4 (Day 2)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5
timeFrame: Pre-dose 5 (Day 3)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6
timeFrame: Pre-dose 6 (Day 3)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
timeFrame: Anytime between 4 to 5 hours post-dose 6 (Day 3)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7
timeFrame: Pre-dose 7 (Day 4)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8
timeFrame: Pre-dose 8 (Day 4)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9
timeFrame: Pre-dose 9 (Day 5)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10
timeFrame: Pre-dose 10 (Day 5)
measure: Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
timeFrame: Anytime between 40 to 48 hours post-dose 10 on Day 5
measure: Part A: Number of Participants With Abnormal Hematology Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose
timeFrame: At 48 hours post-dose on Day 1
measure: Part B: Number of Participants With Abnormal Hematology Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10
timeFrame: Anytime between 40 to 48 hours post-dose 10 on Day 5
measure: Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose
timeFrame: At 48 hours post-dose on Day 1
measure: Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10
timeFrame: Anytime between 40 to 48 hours post-dose 10 on Day 5
measure: Part A: Number of Participants With Abnormal Urinalysis Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose
timeFrame: At 48 hours post-dose on Day 1
measure: Part B: Number of Participants With Abnormal Urinalysis Results at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10
timeFrame: Anytime between 40 to 48 hours post-dose 10 on Day 5
measure: Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
timeFrame: Anytime between 4 to 5 hours post-dose on Day 1
measure: Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose
timeFrame: Anytime between 18 to 24 hours post-dose on Day 1
measure: Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose
timeFrame: 48 hours post-dose on Day 1
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
timeFrame: Baseline (pre-dose on Day 1)
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
timeFrame: Anytime between 4 to 5 hours post-dose 1 on Day 1
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3
timeFrame: Pre-dose 3 (Day 2)
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5
timeFrame: Pre-dose 5 (Day 3)
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
timeFrame: Anytime between 4 to 5 hours post-dose 6 (Day 3)
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8
timeFrame: Pre-dose 8 (Day 4)
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10
timeFrame: Pre-dose 10 (Day 5)
measure: Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
timeFrame: Anytime between 40 to 48 hours post-dose 10 on Day 5
Secondary outcomes:
measure: Part A: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
measure: Part B: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part A: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
measure: Part B: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1
measure: Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
measure: Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part A: Terminal Half-life (t1/2)
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
measure: Part B: Terminal Half-life (t1/2)
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
measure: Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part A: Trough Concentration at the End of First Dosing Interval (C12)
timeFrame: At 12 hours post-dose on Day 1
measure: Part B: Trough Concentration at the End of Dose 6 (C12)
timeFrame: At 12 hours post-dose 6
measure: Part A: Predicted Plasma Clearance
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
measure: Part B: Predicted Plasma Clearance
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration
timeFrame: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
measure: Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part B: Accumulation Ratio
timeFrame: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part B: Percentage Fluctuation
timeFrame: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau)
timeFrame: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part B: Average Plasma Concentration Over Dosing Interval (Cavg)
timeFrame: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
measure: Part B: Minimum Observed Plasma Concentration
timeFrame: Day 3 Dose 6 (pre-dose)
measure: Part B: Plasma Trough Concentration
timeFrame: Day 3 Dose 6 (pre-dose)
measure: Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
timeFrame: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
measure: Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)
timeFrame: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
measure: Part B: Time to Resolution of RSV-Related Signs and Symptoms
timeFrame: Up to Day 12
measure: Part B: Time to Improvement in RSV-Related Signs and Symptoms
timeFrame: Up to Day 12
measure: Part B: RSV Clinical Scoring System Scores
timeFrame: Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Hospital Interzonal General de Agudos "Dr. José Penna"
state: Buenos Aires
city: Bahia Blanca
country: Argentina
facility: Hospital Italiano Regional Del Sur
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital General de Ninos Pedro de Elizalde
state: Caba
city: Calgary
country: Canada
facility: Hospital de ninos "Ricardo Gutierrez"
state: Alberta
city: Santiago
country: Chile
facility: Hospital de Ninos Dr. Roberto del Rio
state: Metropolitana
city: Osorno
country: Chile
facility: Hospital Base San Jose Osorno
state: Region DE LOS Lagos
city: San Jose
country: Costa Rica
facility: Corporacion Gihema
city: San Jose
country: Costa Rica
facility: Hospital Clinica Biblica
city: San Jose
country: Costa Rica
facility: Hospital Metropolitano, Sede San Jose
city: San Jose
country: Costa Rica
facility: lnstituto de lnvestigacion en Ciencias Medicas(IICIMED)
city: San Jose
country: Costa Rica
facility: Policlinico San Bosco, Consultorio de Pediatria, Dr. Arturo Solis Moya
city: Budapest
country: Hungary
facility: Semmelweis Egyetem 11.sz. Gyermeklinika
city: Budapest
country: Hungary
facility: Eszak-Kozep-budai Centrum,Uj Szent Janos Korhaz es Szakrendelo,Gyermekosztaly
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petach Tikava
country: Israel
facility: Schneider Children's Medical Center of Israel
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Pediatrics, SoonchunHyang University Seoul Hospital
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Taiping
country: Malaysia
facility: Hospital Taiping
state: Perak
city: Seberang Jaya
country: Malaysia
facility: Hospital Seberang Jaya
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Sibu
country: Malaysia
facility: Hospital Sibu
state: Sarawak
city: Kuala Terengganu
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
state: Terengganu
city: Parek
country: Malaysia
facility: Hospital Seri Manjung
city: Riddiford Street
country: New Zealand
facility: Capital and Coast DHB, Wellington Hospital
state: Wellington
city: Panama
country: Panama
facility: Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"
city: Panama
country: Panama
facility: Hospital del Nino Dr. Jose Renan Esquivel
city: Panama
country: Panama
facility: Hospital Materno Infantil Jose Domingo de Obaldia
city: Krakow
country: Poland
facility: Uniwersytecki Szpital Dzieciecy w Krakowie
city: Lodz
country: Poland
facility: lnstytut Centrum Zdrowia Matki Polki Klinika Pediatrii, Immunologii i Nefrologii
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie Oddzial Kliniczny Pediatrii
city: Espluges De Llobregat
country: Spain
facility: Hospital Universitario Sant Joan de Deu
state: Barcelona
city: Barcelona
country: Spain
facility: Fundacion Hospital de Nens
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Clinico de San carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz ,Pediatric Deparment
city: Madrid
country: Spain
facility: Hospital Universitario La Paz Servicio de Farmacia. Planta baja Edificio Norte
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario de Santiago
city: Hsinchu City
country: Taiwan
facility: Hsinchu Mackay Memorial Hospital
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
city: Bangkoknoi
country: Thailand
facility: The Pharmacy Unit Ground Floor, OPD Building Faculty of Madicine,
state: Bangkok
city: Patumwan
country: Thailand
facility: Chula Clinical Research Center, Faculty of Medicine
state: Bangkok
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
city: Bangkok
country: Thailand
facility: QueenSirikit National Institute of Child Health {QSNICH}
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital,Faculty of Medicine, Chiang Mai University
city: Chiangrai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
city: khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
city: Phitsanulok
country: Thailand
facility: Naresuan University Hospital ,Faculty of Medicine, Naresuan University
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust Institute in the Park
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust Evelina London Children's Hospital Westminster
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust St Mary's Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust NIHR Clinical Research Facility ,Mailpoint 218,
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: