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165 Clinical Paid Trials near Miami, FL
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
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ABX-002 for Bipolar Depression
Miami, Florida
The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment shows effects on brain chemistry that may relate to anti depressive effects
This is a single treatment arm, open-label, Phase 2 study of ABX-002 in 30 adults with bipolar disorder and 5 healthy volunteers. Healthy volunteer participants will receive no drug treatment and will undergo 2 imaging sessions to confirm instrument and test - retest method reliability control. For bipolar disorder participants with depression, the study will include 3 study periods:
1. Screening Period of up to 4 weeks
2. 6-week Treatment Period
3. 2-week post dose Safety Follow-up Period.
For healthy volunteers, the study will include 2 study periods:
1. Screening Period of up to 3 weeks
2. Imaging Period of up to 3 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Rapid Cycler, Schizophrenia, OCD, Others
Must Be Taking:Mood Stabilizers, Atypical Antipsychotics
35 Participants Needed
Investigational Vaccine for Chickenpox
Miami, Florida
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 15
Key Eligibility Criteria
Disqualifiers:Immunosuppressive Conditions, Neurological Disorders, Tuberculosis, Others
Must Not Be Taking:Immune-modifying Drugs
1840 Participants Needed
Investigational Vaccine for Chickenpox
Miami, Florida
The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 15
Key Eligibility Criteria
Disqualifiers:Immunosuppressive Conditions, Neurological Disorders, Others
Must Not Be Taking:Immune-modifying Drugs, Corticosteroids
750 Participants Needed
RSV Vaccine for Adults 60+
Miami, Florida
The purpose of this study is:
* To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose,
* To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine,
* To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Immunodeficient Conditions, Serious Illness, Others
Must Not Be Taking:Immunosuppressants, Immune-modifying Drugs
10356 Participants Needed
COVID-19 Vaccine + RSV Vaccine for Adults 50+
Coral Gables, Florida
This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Not Listed
842 Participants Needed
MAP
Miami, Florida
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55 years to 90 years. The RCT will last 18 months and have 4 visits: baseline, 6-months, 12-months, and 18-months. The RCT will be preceded by a screening phase followed by randomization and a titration period in which drug/placebo will be titrated from 500 mg a day (one tablet) to 2,000 mg a day (4 tablets), in increments of 500 mg (one tablet) every 10 days. Participants will remain in the RCT on the tolerated dose, and included in analyses on an intent to treat basis. We expect the attrition rate to be 10%/year. Neuropsychological battery, clinical interviews, physical exam, and phlebotomy will be conducted at baseline and every 6 months. Brain MRI will be conducted in approximately half of the participants (186) twice, at baseline, and after the last study visit at month 18. We will also conduct brain amyloid Positron Emission Tomography (PET) using 18F-Florbetaben, and tau PET using 18F-MK6240 in half of the participants at baseline and end of the RCT.
The primary clinical outcome of the study will be changes in the Free and Cued Selective Reminding Test. The secondary endpoints are 1) changes in global cognitive performance, measured with the Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC); 2) changes in neurodegeneration, ascertained as cortical thickness in areas affected by AD on brain MRI; 3) changes in cerebrovascular disease, ascertained as white matter hyperintensities (WMH) volume on brain MRI; 4) Changes in whole brain amyloid ß (Aß) SUVR and in incident amyloid positivity; 5) Changes in tau SUVR in a composite brain region comprising medial and inferolateral temporal cortex; 6) Changes in plasma AD biomarkers.
The data coordinating center and Imaging Core is located at John Hopkins University. The PET coordinating center is located at UC-Berkeley. The Clinical Coordinating and Monitoring Center and the central laboratory will be located at Columbia. The Research pharmacy function will be shared by the University of Rochester, which will dispense randomization kits, and the University of Iowa, which will receive bulk metformin and identical matching placebo from EMD Serono.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Diabetes, Liver Disease, Depression, Others
Must Not Be Taking:Diabetes Medications, Benzodiazepines, Narcotics, Amyloid Treatments
326 Participants Needed
MK-8527 for HIV Prevention
Miami, Florida
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.
The goals of this study are to learn:
* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
* About the safety of MK-8527 and if people tolerate it
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16+
Key Eligibility Criteria
Disqualifiers:Hepatitis B, Recent Malignancy, Others
Must Not Be Taking:Cabotegravir, Lenacapavir, Others
4390 Participants Needed
This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Guillain Barré, Metastatic Malignancy, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids, Others
526 Participants Needed
Chickenpox + MMR Vaccines for Chickenpox
Coral Gables, Florida
This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 15
Key Eligibility Criteria
Disqualifiers:Immunosuppressive Conditions, Neurological Disorders, Others
Must Not Be Taking:Immune-modifying Drugs, Corticosteroids
900 Participants Needed
PCV21 Vaccine for Pneumococcal Infections
Miami, Florida
The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:7 - 17
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Seizures, Neurological Disorders, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids, Anticoagulants, Others
1268 Participants Needed
Pneumococcal Vaccine for Pneumonia Prevention
Miami, Florida
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:42 - 89
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Seizures, Bleeding Disorders, Others
Must Not Be Taking:Immunosuppressants, Anticoagulants, Corticosteroids, Others
2320 Participants Needed
PCV21 for Pneumonia Vaccine
Miami, Florida
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:42 - 89
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Seizures, Bleeding Disorders, Others
Must Not Be Taking:Immunosuppressants, Anticoagulants
580 Participants Needed
Tapinarof Cream for Plaque Psoriasis
Miami, Florida
To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Unstable Psoriasis, Immunosuppression, Others
Must Not Be Taking:Biologics, Systemic Steroids
560 Participants Needed
PCV21 Vaccine for Pneumonia
Miami, Florida
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints.
There will be 6 study visits:
-Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:42 - 89
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Seizure, Bleeding Disorder, Others
Must Not Be Taking:Immunosuppressants, Anticoagulants
1630 Participants Needed
mRNA Vaccine for Flu
Miami, Florida
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Malignancy, Anaphylaxis, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants, Antivirals, Others
56000 Participants Needed
AD109 for Obstructive Sleep Apnea
Miami, Florida
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Others
1280 Participants Needed
RSV Vaccine for Infants and Toddlers
Miami, Florida
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine \[Vaxelis® or Pentacel® and Recombivax HB®\] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6 - 12
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Chronic Illness, Wheezing, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
2226 Participants Needed
DOR/ISL for HIV
Miami Beach, Florida
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV-2, Active Hepatitis B, Cirrhosis, Others
537 Participants Needed
Lyme Disease Vaccine for Healthy Children
Miami, Florida
This study is to understand if the study vaccine (called VLA15) is safe in healthy children.
We are looking for children who:
* are healthy
* are age 5 through 17
* have not been diagnosed with any form of Lyme disease in the past
* have not received any vaccines for Lyme disease in the past
Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.
Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.
Everyone participating in this study will:
* get the shots in a clinic or in a hospital office
* receive a total of 4 shots
* receive the first 3 shots within 6 months
* receive the last shot about 1 year afterwards
* need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Pregnancy, Immunodeficiency, Lyme Disease, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
3235 Participants Needed
AR1001 for Alzheimer's Disease
Miami, Florida
This trial tests AR1001, a medicine for early Alzheimer's Disease. It focuses on people in the early stages of Alzheimer's, aiming to improve their condition through multiple mechanisms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Pregnancy, Delirium, Schizophrenia, Cancer, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
1535 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
mRNA-1273.214 Vaccine for COVID-19 in Children
Miami, Florida
This trial tests updated COVID-19 vaccines on young children. The vaccines use mRNA to teach the body to recognize and fight the virus. The study aims to ensure these vaccines are safe and effective for this age group.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 5
Key Eligibility Criteria
Disqualifiers:SARS-CoV-2 Infection, Immunodeficiency, Others
Must Not Be Taking:Immunosuppressants, Monoclonal Antibodies
1860 Participants Needed
mRNA-1345 Vaccine for Respiratory Syncytial Virus
Miami Beach, Florida
This trial is testing a new vaccine called mRNA-1345 to see if it can prevent lung infections caused by the RSV virus. The vaccine works by teaching the body to recognize and fight the virus. The study will include people who are at risk of these infections and will compare the effects of the vaccine to a non-treatment group.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Guillain-Barré, Other Vaccines, Others
36814 Participants Needed
RSVpreF Vaccine for Bronchitis
Miami, Florida
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:
* At a dose of 120µg.
* In adults 60 years of age and older.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.
Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in the United States and Argentina.
Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in Argentina.
Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States and Canada.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Metastatic Malignancy, End-stage Renal Disease, Unstable Cardiac Disease, Immunodeficiency, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
38861 Participants Needed
Lenacapavir for HIV Prevention
Miami, Florida
This trial is testing lenacapavir, a drug that may help prevent HIV. It targets people who are at risk of getting HIV. The drug works by stopping the virus from making more copies of itself. Lenacapavir was developed by Gilead Sciences Inc. and has been approved for use in combination with other treatments.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:16+
Key Eligibility Criteria
Disqualifiers:Hepatitis, Liver Cirrhosis, Others
Must Not Be Taking:HIV PrEP, HIV PEP
3292 Participants Needed
ExPEC9V Vaccine for E. coli Infections Prevention
Miami, Florida
This trial tests a vaccine to protect older adults from serious E. coli infections. The vaccine trains the immune system to recognize and fight off nine types of harmful E. coli bacteria. In earlier studies, a similar vaccine caused fever and/or diarrhea in some participants and provided limited protection against illness.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:End-stage Renal Disease, Bleeding Disorders, Polyneuropathy, Others
19800 Participants Needed
RSV Vaccine for Older Adults
Coral Gables, Florida
This trial is testing a new RSV vaccine by GSK in adults aged 60 and above. The vaccine aims to boost the immune system's ability to fight RSV. The study will also look at how safe the vaccine is and how long its effects last.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Immunodeficient Conditions, Dementia, Unstable Illness, Others
Must Not Be Taking:Immunosuppressants, Immune-modifying Drugs
1720 Participants Needed
This trial is testing a new drug combination (isatuximab, lenalidomide, and dexamethasone) in patients with high-risk smoldering multiple myeloma. The treatment aims to boost the immune system to fight cancer cells and prevent the disease from getting worse. Lenalidomide helps the immune system and directly targets cancer cells.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, Cardiac Disease, Others
Must Be Taking:Lenalidomide, Dexamethasone
337 Participants Needed
9vHPV Vaccine for HPV-Related Oral Infections in Men
Miami, Florida
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.
There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:20 - 45
Sex:Male
Key Eligibility Criteria
Disqualifiers:Immunocompromised, Autoimmune Conditions, Drug Abuse, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids, Chemotherapy, Others
6033 Participants Needed
F/TAF for HIV Pre-Exposure Prophylaxis
Miami, Florida
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Grade 3/4 Proteinuria, Glycosuria, Others
Must Be Taking:Emtricitabine/tenofovir
5399 Participants Needed
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:30 - 70
Key Eligibility Criteria
Disqualifiers:Mature B ALL, Active Malignancy, Others
Must Be Taking:Antiretrovirals
488 Participants Needed
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