Active clinical trials for "Gastroenteritis"

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. This study will provide data for Korean regulatory authorities about the immunogenicity and safety of this vaccine in Korean children aged 2 months at the time of the first dose.

Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in children aged less than 5 years worldwide and are reported to infect nearly every child by the age of 5 years. About 90% of all rotavirus-associated fatalities occur in low income countries in Africa and Asia and are related to poor health care. In view of high global RVGE burden, the World Health Organization (WHO) on 5th June 2009, recommended the inclusion of rotavirus vaccine in all the national immunization programs. Currently available rotavirus vaccines, RotaTeq® and Rotarix®, are WHO prequalified vaccines which are stable for recommended duration at storage temperature between 2-8 °C. However, if these vaccine are exposed to temperatures above 30 °C, the vaccine has to be discarded due to lost potency. It is very difficult to maintain the cold chain required to conserve the vaccine potency particularly in developing and low income countries, resulting in large amount of vaccine being wasted and in worst case scenario, endangering the lives of potential recipients. The WHO estimates that nearly half of freeze-dried and quarter of liquid vaccines are wasted each year. One of the biggest contributors to this wastage is disruption of the cold chain systems. Hilleman Labs new Rotavirus vaccine is a lyophilized heat stable rotavirus vaccine comprising of five live attenuated reassortant rotaviruses similar to RotaTeq®. The new heat stable rotavirus vaccine (HSRV) formulation offers a stability profile of 9 months at 45 °C and 12 months at 37 °C. This new heat stable formulation (HSRV) could be transported in non-refrigerated supply chain significantly reducing the cost and complications associated with transporting vaccine to remote corners of the developing world. Heat-stable rotavirus vaccine (HSRV) has a potential to sustain high temperatures frequently encountered in regions where majority of rotavirus burden exists and has potential to partially or completely eliminate cold chain dependence. The current study has been designed to test for the first time in humans, the safety and tolerability of the new heat stable rotavirus vaccine (HSRV) in adults; followed by safety and immunogenicity in infants of age 6-8 weeks, as compared to the licensed RotaTeq® vaccine.

This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT) from ETEC, administered by the Intradermal (ID) route. The sample size has been determined based on the historic sample, not on power calculations.The study will involve 99 subjects (83 vaccinees and 16 placebo controls) in 4 consecutive cohorts of 16 individuals each (13 vaccinees and 3 placebo controls) and the final cohort of 35 (31 vaccinees and 4 placebos) subjects. The primary objective is to assess the safety and tolerability of dmLT vaccine when administered in three doses intradermally over a range of dosages in healthy adult subjects.

A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.

Acute illness is the most common presentation of children attending ambulatory care settings. Serious infections (e.g. meningitis, sepsis, pyelonephritis, pneumonia) are rare, but their impact is quite large (increased morbidity, mortality, induced fear in parents and defensive behaviour in clinicians). Early recognition and adequate referral of serious infections are essential to avoid complications (e.g. hearing loss after bacterial meningitis) and their accompanied mortality. Secondly, we aim to reduce the number of investigations, referrals, treatments and hospitalisations in children who are diagnosed with a non-serious infection. Apart from the cost-effectiveness, this could lead to less traumatic experiences for the child and less fear induction for the concerned parent. Finally, we aim to support the clinicians to rationalise their antibiotic prescribing behaviour, resulting in a reduction of antibiotic resistance in the long run.

Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's diarrhea and are significant pathogens affecting children and elderly individuals of developing countries. The purpose of the study is to determine the safety of the ETEC-Cholera vaccine and the body's ability to protect itself against ETEC and cholera infection after receiving the vaccine. The study will enroll a total of 64 healthy volunteers, 18 to 45 years old at the Cincinnati Children's Hospital. The study will provide increasing doses of the vaccine or placebo (inactive substance) to 4 groups consisting of 16 participants each. Participants will remain in the inpatient unit for observation for about 11 days. All subjects will be treated with Cipro, an antibiotic, for 5 days. Study procedures include: blood samples, vital signs, physical examinations, and stool samples. Volunteers will be involved in the study for about 8 months including telephone contacts.

The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) to determine the population effectiveness of Rotarix in Bangladeshi children. Villages in both intervention and government comparison areas will be included in this evaluation. We propose to introduce Rotarix into half of the villages of the Matlab HDSS. In villages randomized to receive the vaccine, all eligible children will be offered Rotarix during their first two Expanded Programme on Immunization (EPI) visits, as would routinely be done if Rotarix were included in the Government EPI schedule. In villages randomized not to receive Rotarix, children will receive their EPI vaccinations exactly as they would have in the absence of this study. Administration of Rotarix will be conducted by regular EPI staff, but ICDDR,B study staff will be present to document informed consent and collect study-specific information. The Ministry of Health will be an active partner in this evaluation since they will be the agency which may follow up with any subsequent vaccine programme. Vaccination with Rotarix will be recorded on the infant's immunization card which is normally used by the EPI programme, but also on a separate study-specific data collection form. Vaccination with Rotarix will continue from study initiation through June 30, 2011. Surveillance for rotavirus gastroenteritis will occur at Matlab Diarrhoeal Hospital and the community treatment centres of the Matlab HDSS continuously throughout the study period. Diarrheal illness information collected through surveillance will be linked to Rotarix study-specific data through the subject's HDSS identification numbers. The primary study endpoint will be the occurrence of an illness episode of acute diarrhoea, among infants and children admitted to a medical facility, determined to be caused by wild-type rotavirus found in a stool specimen. At the end of the surveillance period, rates of this primary study endpoint among age-eligible infants will be compared for villages randomized to receive Rotarix versus for villages randomized not to receive Rotarix. We expect that the rates of rotavirus diarrhoea will be significantly lower among children from the vaccinated villages. The first participant was enrolled in the study on September 23, 2008. Till date (May 12, 2010) a total of 2,882 participants have been enrolled and received first dose. 2,684 participants received second dose of Rotarix. There were 1013 cases gastroentritis reported to diarrhoeal treatment centres among <2 years old children from the vaccinated and unvaccinated villages. There were six death cases among the children who received Rotarix vaccine. These death cases were not related to the vaccines/study products.

This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.

This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.