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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04225897
Other study ID # REVC003
Secondary ID C5241003
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 13, 2019
Est. completion date December 5, 2022

Study information

Verified date June 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 51
Est. completion date December 5, 2022
Est. primary completion date December 5, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 36 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RV521
RV521 is an RSV F protein inhibitor administered orally
Placebo
vehicle administered orally

Locations

Country Name City State
Argentina Hospital Interzonal General de Agudos "Dr. José Penna" Bahia Blanca Buenos Aires
Argentina Hospital Italiano Regional Del Sur Bahia Blanca Buenos Aires
Argentina Hospital General de Ninos Pedro de Elizalde Ciudad Autonoma de Buenos Aires Caba
Canada Hospital de ninos "Ricardo Gutierrez" Calgary Alberta
Chile Hospital Base San Jose Osorno Osorno Region DE LOS Lagos
Chile Hospital de Ninos Dr. Roberto del Rio Santiago Metropolitana
Costa Rica Corporacion Gihema San Jose
Costa Rica Hospital Clinica Biblica San Jose
Costa Rica Hospital Metropolitano, Sede San Jose San Jose
Costa Rica lnstituto de lnvestigacion en Ciencias Medicas(IICIMED) San Jose
Costa Rica Policlinico San Bosco, Consultorio de Pediatria, Dr. Arturo Solis Moya San Jose
Hungary Eszak-Kozep-budai Centrum,Uj Szent Janos Korhaz es Szakrendelo,Gyermekosztaly Budapest
Hungary Semmelweis Egyetem 11.sz. Gyermeklinika Budapest
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Israel Soroka University Medical Center Beer-Sheva
Israel Rambam Health Care Campus Haifa
Israel Schneider Children's Medical Center of Israel Petach Tikava
Korea, Republic of Department of Pediatrics, SoonchunHyang University Seoul Hospital Seoul
Korea, Republic of Seoul National University Children's Hospital Seoul
Malaysia Hospital Raja Perempuan Zainab II Kota Bharu Kelantan
Malaysia Hospital Sultanah Nur Zahirah Kuala Terengganu Terengganu
Malaysia Sarawak General Hospital Kuching Sarawak
Malaysia Hospital Seri Manjung Parek
Malaysia Hospital Seberang Jaya Seberang Jaya Pulau Pinang
Malaysia Hospital Sibu Sibu Sarawak
Malaysia Hospital Taiping Taiping Perak
New Zealand Capital and Coast DHB, Wellington Hospital Riddiford Street Wellington
Panama Hospital de Especialidades Pediatricas "Omar Torrijos Herrera" Panama
Panama Hospital del Nino Dr. Jose Renan Esquivel Panama
Panama Hospital Materno Infantil Jose Domingo de Obaldia Panama
Poland Uniwersytecki Szpital Dzieciecy w Krakowie Krakow
Poland lnstytut Centrum Zdrowia Matki Polki Klinika Pediatrii, Immunologii i Nefrologii Lodz
Poland Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie Oddzial Kliniczny Pediatrii Warszawa
Spain Fundacion Hospital de Nens Barcelona
Spain Hospital Universitario Sant Joan de Deu Espluges De Llobregat Barcelona
Spain Clinica Universidad de Navarra Madrid
Spain Hospital Clinico de San carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de la Paz ,Pediatric Deparment Madrid
Spain Hospital Universitario La Paz Servicio de Farmacia. Planta baja Edificio Norte Madrid
Spain Clinica Universidad de Navarra Pamplona
Spain Complejo Hospitalario de Santiago Santiago de Compostela
Taiwan Hsinchu Mackay Memorial Hospital Hsinchu City
Taiwan Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Hualien
Taiwan Kaohsiung Veterans General Hospital Kaohsiung City
Taiwan Chi Mei Medical Center Tainan City
Thailand King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University Bangkok
Thailand QueenSirikit National Institute of Child Health {QSNICH} Bangkok
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University Bangkoknoi Bangkok
Thailand The Pharmacy Unit Ground Floor, OPD Building Faculty of Madicine, Bangkoknoi Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital,Faculty of Medicine, Chiang Mai University Chiang Mai
Thailand Chiangrai Prachanukroh Hospital Chiangrai
Thailand Faculty of Medicine, Khon Kaen University khon Kaen
Thailand Srinagarind Hospital, Faculty of Medicine, Khon Kaen University Khon Kaen
Thailand Chula Clinical Research Center, Faculty of Medicine Patumwan Bangkok
Thailand Naresuan University Hospital ,Faculty of Medicine, Naresuan University Phitsanulok
United Kingdom Alder Hey Children's NHS Foundation Trust Institute in the Park Liverpool
United Kingdom Guy's and St Thomas' NHS Foundation Trust Evelina London Children's Hospital Westminster London
United Kingdom Imperial College Healthcare NHS Trust St Mary's Hospital London
United Kingdom University Hospital Southampton NHS Foundation Trust NIHR Clinical Research Facility ,Mailpoint 218, Southampton

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Canada,  Chile,  Costa Rica,  Hungary,  Israel,  Korea, Republic of,  Malaysia,  New Zealand,  Panama,  Poland,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing incidence of AEs, TEAEs, SAEs, and withdrawals due to TEAEs. Summary tables of AEs will be based on TEAEs, defined as events starting, or worsening, after the first dose of IMP. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing changes in physical examinations. Results at each visit will be summarised using the statistics: n (number of observations), mean, SD, median, minimum and maximum. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing systolic BP (vital sign parameters) and changes from baseline Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing diastolic BP (vital sign parameters) and changes from baseline Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing body temperature (vital sign parameters) and changes from baseline Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing respiration rate (vital sign parameters) and changes from baseline Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing heart rate (vital sign parameters) and changes from baseline Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary To evaluate the safety and tolerability of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing pulse oximetry (vital sign parameters) and changes from baseline Baseline characteristics will be summarized descriptively by treatment. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary Number of participants with changes in haematology/clinical chemistry/urinalysis laboratory values (laboratory tests read by a central lab) from baseline in Part A and Part B. Results at each visit will be summarised using the statistics n, mean, standard deviation, median, minimum and maximum. Also, change from baseline will also be summarised by post baseline visits. 48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary Number of participants with changes in ECG measurements from baseline in Part A and Part B Parameters collected will be:
Ventricular Heart Rate (bpm)
PR Interval (msec)
QRS Interval (msec)
QT Interval (msec)
QTcB Interval (msec)
Results at each visit will be summarised using the statistics: n (number of observations), mean, SD, median, minimum and maximum.
48 hours post dose 1 (Part A) and 48 hours post dose 10 (Part B)
Primary Part C: Evaluate the effect of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to show time to resolution of symptoms. Overall time to resolution of RSV-related signs and symptoms will be calculated from the time of randomization to the time that they are no longer present (absent or severity =0), and will be summarized and analysed as Time to Improvement. up to 48 hours post dose 10
Primary Part C: Evaluate the effect (efficacy) of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess time to change of symptoms. Time to change in symptoms will be calculated for RSV-related signs and symptoms that are classified as moderate or severe during the course of the study and will be defined as the time from randomization until no longer present (absent or severity=0) or mild (scores = 5). up to 48 hours post dose 10
Primary Part C: Evaluate the effect (efficacy) of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess change in severity of symptoms Change in severity of symptoms by RV521, compared to placebo, will be measured by a composite score over time. up to 48 hours post dose 10
Primary Part C: Evaluate the effect (efficacy) of RV521, compared to placebo, on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess use of supplemental oxygen. Duration and maximum level of O2 provided will be assessed. up to 48 hours post dose 10
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing time to maximum plasma concentration (tmax). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing maximum observed plasma concentration (Cmax). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing area under the plasma concentration time curve from time zero to 12 hours (AUC0-12). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the PK of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing the area under the plasma concentration time curve from time zero to last measurable plasma concentration (AUC0 t). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing terminal half-life (t1/2). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing area under the plasma concentration time curve from time zero to infinity (AUC0-8). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing predicted plasma clearance. Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing apparent volume of distribution of the drug after extravascular administration (V/F). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of single (Part A) and multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing trough concentration at the end of first dosing interval (C12) (data permitting). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 1 (Part A)
Secondary To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing accumulation ratio, percent fluctuation. Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 10
Secondary To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing the area under the plasma concentration time curve from time zero to the end of last dosing interval (AUC0-tau). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 10
Secondary To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing average plasma concentration over dosing interval (Cave). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 10
Secondary To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing minimum observed plasma concentration (Cmin). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 10
Secondary To characterise the pharmacokinetics (PK) of multiple (Part B) oral doses of RV521 in infants hospitalised with RSV LRTI by assessing plasma trough concentration (Ctrough). Pharmacokinetic analysis will include listings and summaries of PK concentrations by time point, derived PK, parameters and analysis of relationship with dose and body weight. 48 hours post dose 10
Secondary Part B: To evaluate the antiviral effects of RV521 in infants hospitalised with RSV LRTI by RSV viral load measured in nasopharyngeal swabs by RT qPCR. Pharmacodynamics analysis will include listing of results of viral load with summary statistics by dose level and time point. up to 48 hours post dose 10
Secondary Part B: To evaluate the antiviral effects of RV521 in infants hospitalised with RSV LRTI by RSV viral load measured in nasopharyngeal swabs by CBIA. Pharmacodynamics analysis will include listing of results of viral load with summary statistics by dose level and time point. up to 48 hours post dose 10
Secondary Part B: Evaluate the effect of RV521 compared to placebo on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess time to resolution of symptoms. Overall Time to Resolution of RSV-related signs and symptoms will be calculated from the time of randomization to the time that they are no longer present (absent or severity =0), and will be summarized and analysed as for Time to Improvement. 48 hours post dose 10
Secondary Part B: Evaluate the effect of RV521 compared to placebo on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess time to improvement evaluated by change in severity of symptoms. Time to improvement will be calculated for RSV-related signs and symptoms that are classified as moderate or severe during the course of the study and will be defined as the time from randomization until no longer present (absent or severity=0) or mild (scores = 5). 48 hours post dose 10
Secondary Part B: Evaluate the effect of RV521 compared to placebo on the clinical course of RSV LRTI using the RSV Clinical Scoring System and the Adapted Version of ReSVinet Scale to assess change in severity of symptoms. Change in severity of symptoms by RV521, compared to placebo, will be measured by a composite score over time. 48 hours post dose 10
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