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Typhoid Fever clinical trials

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NCT ID: NCT04204096 Completed - Typhoid Clinical Trials

Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)

Start date: February 4, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population. The study objectives are as follows: - Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45 year age stratum), at 4 weeks after a single dose. - Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion rates of anti-Vi IgG antibody titres of multi dose formulation against single dose formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose. - Secondary objective 2. Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD formulation/control (Meningococcal Conjugate Vaccine). There are total 5 scheduled visits as follows: - Visit 1(D-7 to 0): Screening - Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above) - Visit 3(D7): Safety follow-up - Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above) - V5(D168): Safety follow-up

NCT ID: NCT04154722 Completed - Typhoid Fever Clinical Trials

Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children

[XDRTYPHOID]
Start date: June 20, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).

NCT ID: NCT04083950 Active, not recruiting - Inflammation Clinical Trials

Induction of Gut Permeability by an Oral Vaccine

Start date: December 4, 2019
Phase: Early Phase 1
Study type: Interventional

This study evaluates the effect of an oral typhoid vaccine on disruption of the intestinal barrier and response of the immune system. Intestinal and whole-body responses will be measured in all participants before and after the vaccine.

NCT ID: NCT04051268 Completed - Safety Issues Clinical Trials

Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

Start date: March 2, 2020
Phase: Phase 3
Study type: Interventional

Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.

NCT ID: NCT03970304 Active, not recruiting - Typhoid Vaccination Clinical Trials

CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

Start date: October 24, 2013
Phase: Phase 4
Study type: Interventional

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups: Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination. The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid vaccine.

NCT ID: NCT03956524 Completed - Typhoid Fever Clinical Trials

Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Start date: March 16, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.

NCT ID: NCT03933098 Active, not recruiting - Typhoid Clinical Trials

Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine

Start date: November 15, 2019
Phase: Phase 3
Study type: Interventional

This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose. The study objectives are: I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT) II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.

NCT ID: NCT03926455 Completed - Typhoid Fever Clinical Trials

Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Start date: March 28, 2016
Phase: Phase 1
Study type: Interventional

This was a randomized, double-blind, ascending dose study conducted at a single clinical research center.

NCT ID: NCT03889067 Completed - Clinical trials for Salmonella Typhi Infection

Understanding How Salmonella Typhi Infects Humans (Bottlenecks)

Start date: May 30, 2019
Phase: N/A
Study type: Interventional

Typhoid fever is an infection caused by the bacteria Salmonella Typhi (S. Typhi). S. Typhi causes disease principally in developing countries where communities do not have access to safe water or adequate sanitation. It is thought to cause illness in approximately 22 million people every year and up to 200,000 deaths, mostly in children. The bacteria are spread when faeces from infected individuals contaminate food and water sources. Symptoms of infection include headache, fever and general aches and pains. If not treated properly typhoid infection can lead to severe complications and even death. In this study the investigators aim to understand more about the S. Typhi bacteria and how S. Typhi causes a bloodstream infection after it has been ingested and passed into the gut. In spite of the extensive morbidity and mortality associated with bacterial blood stream infections (BSI), comparatively little is known about the pathogenesis. At a time of increasing antimicrobial resistance and a lack of new antimicrobial agents, understanding the pathogenesis of BSI is essential for efforts directed at prevention both of Salmonella Typhi and other bacterial species, particularly those that are restricted to humans.

NCT ID: NCT03705585 Recruiting - Clinical trials for Typhoid and/or Cholera Vaccination

CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera

Start date: November 5, 2018
Phase: Phase 4
Study type: Interventional

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine.