A phase II study of the Cuban adult formulation tetanus and diphtheria vaccine.

INTERVENTION: Diphtheria‐Tetanus Vaccine The adolescents were randomly distributed in two groups, respectively immunized with the adult d.T. candidate vaccine, or the control vaccine IMOVAX d.T. adult, bivalent vaccines against tetanus and diphtheria. A single dose of 0,5 mL by intramuscular route was used. The study vaccine was developed by Finlay Institute and is composed of purified diphtheria toxoid (1,5 Lf) and purified tetanus toxoid (5 Lf). Aluminum hydroxide is used as adjuvant. CONDITION: Tetanus tetanus and diphtheria PRIMARY OUTCOME: Primary Objective: To evaluate the immunogenicity of a booster dose of the Cuban adult formulation tetanus and diphtheria vaccine, and the control vaccine IMOVAX d.T. adult, intramuscularly applied to adolescents over 13 years of age that have completed the Cuban schedule of vaccination. Endpoints: 1‐Tetanus and diphtheria antitoxin levels >= 1 IU/mL detected by ELISA (indicative of long‐term protection) 21 days after vaccination. 2‐Protective levels of tetanus antitoxin and diphtheria antitoxin between 0,1 IU/mL and 1,0 IU/mL detected by ELISA 21 days after vaccination. SECONDARY OUTCOME: Secondary Objective: To evaluate the reactogenicity of a booster dose of the Cuban adult formulation tetanus and diphtheria vaccine, and the control vaccine IMOVAX d.T. adult, intramuscularly applied to adolescents over 13 years of age that have completed the Cuban schedule of vaccination. Endpoints: 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. INCLUSION CRITERIA: 1‐A male or female over, and including, 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.