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NCT ID: NCT06097299 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus

Start date: October 24, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years of age and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of age to inform the dose level selection for the next phase of development (Phase 3).

NCT ID: NCT05836012 Active, not recruiting - Gastroenteritis Clinical Trials

Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines

Start date: June 2, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 2, multi-country, randomized, double-blind, placebo-controlled trial to evaluate the immune response to routine pediatric vaccinations when co-administered with HIL-214 or placebo in healthy infants. This trial will also evaluate the safety profile of a 2-dose regimen of HIL-214 co-administered with routine pediatric vaccines.

NCT ID: NCT05743881 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Start date: February 15, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to <24 months.

NCT ID: NCT05522296 Active, not recruiting - Mpox Clinical Trials

Break-through Infection Following Mpox vaccinatIon

REMAIN
Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.

NCT ID: NCT05293665 Active, not recruiting - COVID-19 Vaccines Clinical Trials

Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine

Start date: March 16, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, international, randomized, active-controlled platform study with each sub-study designed to randomize subjects to receive a single injection with UB-612 or a comparator COVID-19 vaccine in 1:1 ratio.

NCT ID: NCT05281094 Active, not recruiting - Gastroenteritis Clinical Trials

Efficacy and Safety of Two Doses of HIL-214 in Children

Start date: March 16, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.

NCT ID: NCT05238974 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants

MELODY
Start date: July 23, 2019
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05130944 Active, not recruiting - Stress Clinical Trials

Feasibility of Community Psychosocial Intervention for Women

Start date: September 9, 2021
Phase: N/A
Study type: Interventional

The purpose of the current protocol is to describe a cluster randomized feasibility trial examining the integration of a scalable stress management intervention into Entre Nosotras ('among/between us'), a community-based psychosocial intervention for migrant and host community women in Ecuador and Panamá. Specifically the study aims to: 1. Explore the relevance, acceptability, and feasibility of integrating a stress management intervention into community-based participatory women's group 2. Examine the feasibility of conducting a fully-powered cluster randomized controlled trial evaluating the effectiveness and implementation of integrating a stress management intervention into a community-based participatory women's group as compared to community-based participatory women's groups alone.

NCT ID: NCT05127434 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Start date: November 17, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

NCT ID: NCT05091437 Active, not recruiting - Pulmonary Nodules Clinical Trials

DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis

DOuBLED
Start date: December 30, 2021
Phase:
Study type: Observational

Early diagnosis of LC in the asymptomatic stage through intentional screening programs and/or incidental pulmonary nodule identification and follow-up are known to improve outcomes significantly. There are large gaps in the screening and early detection of LC, especially in LMIC - driven by multifactorial aspects, including a variety of socioeconomic and infrastructural factors, mainly due to limitations in the required network of specialized human resources and technical capacity. Identifying LC at an early stage allows for treatment that is more likely to be curative, thereby improving survival. The present study aims to characterize the lung nodule journey in different hospitals/clinics across Latin America, describing the use of health resources, time to diagnosis, stage at diagnosis, and time to treatment depending on the source of nodule identification in two different cohorts (retrospective and prospective).