Clinical trial to evaluate the safety, reactogenicity and immunogenicity of the vax-TyVi vaccine in volunteers between 18 and 20 years of age.

Phase 1

Completed

• Conditions: typhoid fever; Typhoid Fever; Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Gastrointestinal Diseases; Waterborne Diseases; Environmental Illness

• Registration Number: RPCEC00000056
• Lead Sponsor: Finlay Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1-A male or female between, and including, 18 and 20 years of age at the time of the vaccination. 2-Free from obvious health problems as established by medical history and clinical examination before entering into the study. 3-Written informed consent obtained from the parents or guardians.

Exclusion Criteria

1-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, metabolic or renal functional abnormality, as determined by physical examination. 2-History of typhoid fever. 3- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the vaccination. Inhaled and topical steroids are allowed. 4-Use of other typhoid vaccine within 2 years preceding the study. 5-Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting one month before the application of the study vaccine and ending one month after that application. 6-Any hematological disease. 7-Administration of immunoglobulins and/or any blood products within the three months preceding the single dose of the candidate vaccine or planned administration during the study period. 8-Possibility of administration of any blood by-products during the study period. 9-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 10-A family history of congenital immunodeficiency. 11-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 12-History of any neurological disorders or seizures. 13-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 14-Axillary temperature of >= 37.5°C before vaccination. 15-History of chronic alcohol consumption. 16-Pregnancy (checked by rapid test). 17-breastfeeding mother. 18-Administration of radiotherapy or chemotherapy. 19-Neoplasic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified