Clinical trials: Respiratory Control in Premature Infants
- Condition Respiratory Control in Premature Infants
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Syncytial Virus
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm…
- Trial name
- MEDI8897 1b (NCT02290340)
- Testing
- MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Tract Infection, Respiratory Syncytial Virus
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational…
- Trial name
- NCT03524118
- Testing
- Clesrovimab
- Where
- 34 sites in United States, Chile and 4 more
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering…
- Trial name
- MEDI8897 Ph2b (NCT02878330)
- Testing
- MEDI8897
- Where
- 161 sites in United States, Argentina and 21 more
- Volunteers
- 1,453 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Wheezing
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early…
- Trial name
- NCT00628303
- Testing
- Motavizumab
- Volunteers
- healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infections
A Study of TNM001 in Chinese Healthy Preterm and Term Infants
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants.
- Trial name
- NCT05630573
- Testing
- TNM001
- Where
- 6 sites in China
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
Lower Respiratory Tract Infection
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
- Trial name
- CHIMES (NCT05110261)
- Testing
- Nirsevimab
- Where
- 30 sites in China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- AstraZeneca