15 Clinical Trials for Various Conditions
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment: * RSV/hMPV mRNA / LNP 1 at 3-4 different doses or, * RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or, * RSV mRNA / LNP 1 at 1 dose or, * hMPV mRNA / LNP 1 at 1 dose
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.
The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health.
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.
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 entering their first RSV season.
This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all eligibility criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of a single intranasal dose of Sendai virus vectored Respiratory Syncytial Virus (SeVRSV) vaccine. The subjects will be randomized in a 4:1 ratio to receive SeVRSV vaccine at a dose of 1 x 10\^7 EID50 or placebo (saline) intranasally. Study duration is approximately 11 months with subject participation duration approximately 6 months. The primary objectives are to: 1) assess the safety and reactogenicity of SeVRSV vaccine following receipt of one intranasal dose; 2) assess the ELISA antibody responses to SeV and to the RSV F protein at 28 days post receipt of one intranasal dose of SeVRSV vaccine; 3) assess the detection of vaccine virus from nasal washes at days 3, 5, 8 and 15 following receipt of one intranasal dose of SeVRSV vaccine.
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 their first Respiratory Syncytial Virus (RSV) season.
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 at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.
Respiratory Syncytial Virus (RSV) infections are very common and widespread. By age 5, virtually everyone has been infected and developed antibodies against some strain of the virus. RSV infections happen during adulthood, leading to common cold syndromes. In Bone Marrow Transplant recipients the disease is much more severe, usually progressing to pneumonia. This phenomenon is associated with mortality rates around 60-80%. RSV Polyclonal Immunoglobulin (Respigam® (Registered Trademark)) has been approved by the Food and Drug Administration and recommended by the American Academy of Pediatrics for prophylaxis of RSV disease in premature babies and children born with bronchopulmonary dysplasia. Furthermore, it has been used to treat RSV pneumonia in children and Bone Marrow Transplant recipients with encouraging results and no complications. Currently, no preventive strategies are available when approaching this infection among bone marrow transplant patients. We intend to prevent our bone marrow transplant patients from developing RSV pneumonia by employing the strategy already used in premature babies, i.e., by passive immunization with Respigam® (Registered Trademark). Our goal to evaluate the efficacy and safety of this strategy in such immunocompromised population. We believe that this will be a more reasonable approach than waiting for the infection to settle in and only then treating it, because optimal therapy is not currently available.