typhoid fever
Conditions
Interventions
The children and teenagers were randomly distributed in three groups. They were immunized with the candidate vaccine - vax-TyVi -, or the control vaccines Typhim-Vi and vax-TET. A single dose of 0,5 m
Injections, Intramuscular
vax-TyVi,
Typhim-Vi,
vax-TET
Sponsors
Finlay Institute
Eligibility
Sex/Gender
All
Age
9 Years to 13 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective: To evaluate safety, reactogenicity and immunogenicity of a single dose of the Cuban Salmonella Typhi Vi polysaccharide vaccine, intramuscularly applied to children and teenagers, and demonstrating that the immune response elicited by vax-TyVi is not lower than that induced by the control vaccine Typhim-Vi. Endpoints: Safety and reactogenicity: 1-Occurrence of any grade 3 expected symptoms within 7 days following vaccination. 2-Occurrence of expected local symptoms taking place within 7 days after vaccination. 3-Occurrence of expected general symptoms taking place within 7 days after vaccination. 4-Nature, incidence, intensity and relationship to vaccination of unexpected serious adverse events within 30 days after vaccination. 5-Nature, incidence, intensity and relationship to vaccination of unexpected non-serious adverse events within 30 days after vaccination. 6-Incidence of clinically relevant out-of-range tests for routine hematology (red blood cells, hemoglobin, hematocrit, leukocytes, differential blood count, platelets), routine microscopic urine examination (red blood cells, leukocytes, epithelial cells), serum creatinine and liver enzymes (aspartate aminotransferase – AST or SGOT, alanine aminotransferase – ALT or SGPT), immediately before and 7 days after vaccination. These laboratory tests were carried out in 45 randomly selected teenagers. Immunogenicity: 1-Anti-Vi antibody levels were detected by ELISA prior and 21 days after vaccination in all groups. Seroconversion was defined as 2-fold increase of anti-Vi antibody titers over pre-immunization levels. | — |
Countries
Cuba
Contacts
Public ContactMorelia Baro Suarez
Finlay Institute.
Outcome results
None listed