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Showing 1-15 of 15 trials
NCT06962904
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) for intradermal administration in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.
NCT03483116
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.
NCT03367559
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam.
NCT02542462
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.
NCT00443846
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.
NCT02538211
The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.
NCT00346892
"The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines. The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."
NCT01467037
Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of \< 24 hours is 1/25, which would amount to 13,600 Canadian children \< 5 years. The incidence of nosocomial RV infections is an average of 8/10,000 patient-days in children \< 5 years. An immunization program with a live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented, free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait of the disease and give critical information to the public health agencies as they struggle to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases with similar characteristics; estimate selection bias in passive laboratory-based surveillance; and estimate the agreement between surveillance time-series created from passive and active surveillance data sources.
NCT01357174
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.
NCT00090233
This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.
NCT00092456
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
NCT00981669
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
NCT00757926
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine \[BRV-TV\] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.
NCT00280111
It has been observed that in children who get a severe rotavirus infection, subsequent infections cause either no symptoms or generally only mild or moderate diarrhea. This evidence is the basis for developing a vaccine since it suggests that the first infection immunizes the child against disease upon re-infection. It was found that neonatal avirulent strains 116E and I321 induce protective immunity and offer clinical protection for at least one year. Both these strains are well characterized and the safety studies have been done in animal models. These candidate vaccine strains have been evaluated for safety and immunogenicity in adults and children (2 to 12 years of age) by a randomized double blind placebo controlled trial in Cincinnati, USA. In India, the diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and co-infection with other enteric pathogens. These vaccines have therefore, also been tested in India.
NCT00484952
Objectives 1. To determine the burden and characteristics of rotavirus-associated hospitalizations among children under five years of age of northern Israel 2. To identify potential risk factors of rotavirus infections associated with hospitalizations among Jewish and Arab children younger than five years of age. Methods: Study design: A two-year prospective study and a nested case control study will be carried out Collection of data: Questionnaires will be filled in with demographic characteristics of patients and data on the clinical manifestation of the diarrheal episode leading to hospitalization. Stool specimens will be systematically collected from all children hospitalized because of diarrheal diseases and examined for rotavirus and for bacterial and protozoan enteropathogens. Positive samples for rotavirus will be tested for G and P genotypes. For the nested case control study additional data will be obtained from parents' interviews on variables such as: parents' education, parents' age, parents' occupation, no. of siblings, age of siblings, breastfeeding etc. to identify potential risk factors for rotavirus diarrhea necessitating hospitalization. Data analysis: Methods of descriptive statistics / epidemiology will be applied to determine the characteristics of the burden of rotavirus-associated hospitalizations (the distribution of diarrhea associated hospitalizations by etiology, rates of rotavirus diarrheal diseases in Jewish and Arab children, age specific rates of rotavirus infections, the percentage of hospitalizations due to rotavirus diarrhea by month, etc. For the nested case control study, univariate analysis will be first performed using Student t test for continuous variables and chi square test for categorical variables to study the statistical significance of predictive factors of rotavirus diarrheal diseases necessitating hospitalization. Multivariate analysis using logistic regression models will be performed to study the independent effect of each variable. Odds ratios (OR) and 95% CI will be computed for each variable. Two tailed p \< 0.05 will be considered significant.