TETANUS
Conditions
Interventions
Study group (Experimental cuban vaccine): vax-TET®-5 tetanus vaccine. Single dose of 0.5ml by intramuscular deep inyecction Control group (vaccine): vax-TET® tetanus vaccine. Single dose of 0.5ml by i
Sponsors
Finlay Institute, Center of Research and Production of Vaccines.
Eligibility
Sex/Gender
All
Age
13 Years to 15 Years
Inclusion criteria
Inclusion criteria: - Healthy adolescents of both sexes from 13 years to 15 years. - Signature of the informed consent. - Antecedent of vaccination according to National Vaccination program of the MINSAP. - Good health condition, established for the practitioner criterion, via physical examination.
Exclusion criteria
Exclusion criteria: - Be under processing immunosuppressive (more than 14 days) or another type of medication such as steroids for inhalation that it modifies the immunological state, excluding topical steroids. - Administration of a vaccination not considered in the protocol, 30 days sooner or later of the application of the vaccination in study. - Any suspected or confirmed condition of immunosuppression or immunodeficiency, including a positive examination to the human immunodeficiency virus (1 HIV-1 and 2). - Allergy or exacerbated reaction history to any component of the vaccination of the study. - History of some neurological or convulsions illness. - Acute illness presence severe or moderate (with or without fever) at the time of its incorporation to the study. - Use of some experimental drug 30 days before the study initiated or during its development. - Axillary temperature ³ 37,5 0C before vaccination. - Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity (ELISA technique for tetanus antitoxin. Tetanus antitoxin with values at the rate of 0.01 IU / mL (serum antitoxin units per milliliter) Protective titers, From 0.1 IU / mL, reliable protection titles are reached and Values above 1-UI/mL--- Reliable Titles which confer long-term protection. Measuring time: pre-and post-vaccination response at the day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reactogenicity (Local adverse events (Pain in the injection site, redness in the injection site, induration in the injection site); general adverse events (Fever, Malaise, Headache); unexpected adverse events). Measuring time: 30 days. Active daily surveillance in both groups during 7 days from the day of immunization and after weekly until the remaining 30 days. | — |
Countries
Cuba
Contacts
Public ContactLazaro Aguila Quevedo
Provincial Health Management of Artemisa.
Outcome results
None listed