Study of the tetanus vaccine vax-TET®-5

Phase 2

Conditions: TETANUS

Registration Number: RPCEC00000156

Lead Sponsor: Finlay Institute, Center of Research and Production of Vaccines.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 472

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.