Diarrhoea Clinical Trial
Official title:
A Staged Phase I/II Observer-blind, Randomised, Controlled, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against S. Sonnei and S. Flexneri, Serotypes 1b, 2a, and 3a, in Adults in Europe (Stage 1) Followed by Age De-escalation From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2)
The aim of the current clinical study is to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine will be first administered in adults 18 to 50 years of age in Europe. Subsequently, the vaccine will be administered to a shigellosis-endemic population in Africa, first in adults 18 to 50 years of age, then in children 24 to 59 months of age, and finally in infants 9 months of age. Infants will also receive a third vaccination. Three different doses of the vaccine [low (Dose A), medium (Dose B), and high (Dose C) amounts of antigen] will be evaluated using an age de-escalation approach (from least vulnerable adult population to most vulnerable paediatric population). The results of this study will allow the selection of the most appropriate dose for further vaccine development in infants 9 months of age, which is the main target age group for this vaccine.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01214785 -
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
|
N/A | |
| Completed |
NCT01969214 -
Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
|
N/A | |
| Completed |
NCT01202383 -
Double-blinded Trial of Household-based Chlorination in India
|
Phase 3 | |
| Completed |
NCT00979056 -
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
|
Phase 3 | |
| Completed |
NCT01087892 -
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
|
N/A | |
| Completed |
NCT02072629 -
HCU: Can VHVs Trained in ICCM Improve Care for Children
|
N/A | |
| Completed |
NCT00408356 -
Immunological and Clinical Responses to Zinc in Children With Diarrhoea
|
Phase 3 | |
| Completed |
NCT01517230 -
Can Mass Media Campaigns Reduce Child Mortality
|
N/A | |
| Completed |
NCT02858609 -
Improving the Diagnosis of Diarrhoea in Emergency Rooms
|
N/A | |
| Completed |
NCT01306383 -
Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations
|
N/A | |
| Completed |
NCT00352716 -
Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children
|
Phase 3 | |
| Active, not recruiting |
NCT02606526 -
Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda
|
Phase 3 | |
| Completed |
NCT00352989 -
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children
|
Phase 3 | |
| Completed |
NCT00324285 -
Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children.
|
Phase 3 | |
| Recruiting |
NCT02144168 -
The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients
|
N/A | |
| Withdrawn |
NCT01491659 -
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
|
Phase 4 | |
| Completed |
NCT02797353 -
Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan
|
N/A | |
| Completed |
NCT01557673 -
Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
|
Phase 1/Phase 2 | |
| Completed |
NCT00823056 -
The Effect of Probiotics on Infections in Toddlers
|
Phase 3 | |
| Completed |
NCT01154803 -
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
|
N/A |