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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000059
• Date of registration: 29/07/2008
• Primary sponsor: Finlay Institute
• Public title: A phase II study of the Cuban adult formulation tetanus and diphtheria vaccine.
• Scientific title: A phase II, double-blind, randomized, controlled study to evaluate the reactogenicity and immunogenicity of a booster dose of the Cuban adult formulation tetanus and diphtheria vaccine (adult d.T.) and the control vaccine, IMOVAX d.T. adult, in adolescents.
• Date of first enrolment: 18/12/2005
• Target sample size: 225
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000059-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr Rolando Ochoa Azze
• Affiliation: Finlay Institute

• Name: Dra Morelia Baró Suárez
• Affiliation: Finlay Institute

Key inclusion & exclusion criteria

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.
Exclusion criteria: 1-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. 2-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. 3-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 4-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 5-History of any neurological disorders or seizures. 6-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 7-Use of any investigational or non-registered drug other than the study vaccine within 30 days preceding the single dose of the study vaccine, or planned use during the study period. 8-Pregnancy or breastfeeding. 8-Axillary temperature of >=37.5°C before vaccination.

Age minimum: 13 years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

tetanus and diphtheria

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

IF/d.T./ 01

Source(s) of Monetary Support

Finlay Institute