A phase I/II study to evaluate the Salmonella Typhi Vi polysaccharide vaccine – vax-TyVi – in children and teenagers.

Phase 1

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

• Registration Number: RPCEC00000055
• 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, 9 and 13 years of age at the time of the vaccination. 2-Written informed consent obtained from the parents or guardians. 3-Free from obvious health problems as established by medical history and clinical examination before entering into the study. 4-If the subject is a female of childbearing potential; she must be abstinent or have to use adequate contraceptive precautions during the study. Negative pregnancy tests have to be obtained before vaccination.

Exclusion Criteria

1-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, metabolic or renal functional abnormality, as determined by physical examination. 2- 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. 3-Use of other typhoid vaccine within 2 years preceding the study. 4-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. 5-Any hematological disease. 6-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. 7-Possibility of administration of any blood by-products during the study period. 8-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 9-A family history of congenital immunodeficiency. 10-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 11-History of any neurological disorders or seizures. 12-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 13-Use of any investigational or non-registered drug other than the study vaccine within 30 days preceding the single dose of study vaccine, or planned use during the study period. 14-Axillary temperature of >=37.5°C before vaccination. 15-Administration of immunosuppressants, other immune-modifying drugs or radiotherapy during the study period. Inhaled and topical steroids are allowed. 16-Pregnancy. 17-Difficulties to obtain a blood sample of a subject.

Study & Design

• Study Type: Interventional
• Study Design: Not specified