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Rotavirus Infections clinical trials

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NCT ID: NCT05037435 Completed - Clinical trials for Rotavirus Infections

Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aidâ„¢ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.

Start date: June 25, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the presented study was to evaluate the safety and immunological efficacy in preventing the rotavirus infection within a cohort of healthy subjects (target age of 18-45 years old) by using the pentavalent rotavirus vaccine - Rota-V-Aidâ„¢ (live attenuated oral, freeze-dried).

NCT ID: NCT05032391 Completed - Rotavirus Infection Clinical Trials

Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization

Start date: February 22, 2019
Phase: Phase 3
Study type: Interventional

The first multicenter prospective, randomized, double-blind, placebo-controlled clinical trial of the pentavalent live vaccine for RVI prevention was conducted in Russia among healthy infants aged 2 months at the time of the first vaccination.

NCT ID: NCT03954743 Completed - Clinical trials for Infections, Rotavirus

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start date: July 19, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.

NCT ID: NCT03870061 Completed - Tuberculosis Clinical Trials

Evaluation of an Infant Immunization Encouragement Program in Nigeria

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Previous studies have shown that a small incentive can have a large impact on health behaviors like vaccinating children. New Incentives, an international non-governmental organization (NGO), aims to boost demand for immunization by offering cash incentives to caregivers who have their child vaccinated at a program clinic. In collaboration with New Incentives, IDinsight is conducting a study to see whether this approach will increase immunization in North West Nigeria. This study aims to investigate whether giving cash to caregivers in North West Nigeria who bring their infants to receive vaccination against common infections (tuberculosis, diphtheria, tetanus, pertussis, hepatitis B virus (HBV) infection, Haemophilus influenzae Type B (Hib), pneumococcal bacteria, measles, rotavirus, polio, yellow fever) increases the proportion of children who are immunized. The study's main hypothesis is that New Incentives' program will increase the percentage of children immunized with BCG, any PENTA, or Measles 1 by an average increase of at least 7-percentage points across all program clinics that share a similar profile to the clinics New Incentives will operate in at scale. The study is taking place in Jigawa, Katsina, and Zamfara States between August 2017 and January 2020.

NCT ID: NCT03483116 Completed - Clinical trials for Rotavirus Infections

A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

NCT ID: NCT03207750 Completed - Rotavirus Vaccines Clinical Trials

This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine

Start date: September 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age

NCT ID: NCT02992197 Completed - Clinical trials for Vaccine Response Impaired

The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity

Start date: June 12, 2017
Phase: Phase 4
Study type: Interventional

Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh. Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.

NCT ID: NCT02914184 Completed - Clinical trials for Infections, Rotavirus

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

NCT ID: NCT02542462 Completed - Clinical trials for Rotavirus Infections

Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

Start date: November 2015
Phase: Phase 4
Study type: Interventional

This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.

NCT ID: NCT02538211 Completed - Tetanus Clinical Trials

The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

Rota-biome
Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.