A phase II study of the Cuban vaccine against tetanus and diphtheria VA-DIFTET.

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000058
• Date of registration: 29/07/2008
• Primary sponsor: Finlay Institute
• Public title: A phase II study of the Cuban vaccine against tetanus and diphtheria VA-DIFTET.
• Scientific title: A phase II, double-blind, randomized, controlled study to evaluate the reactogenicity and immunogenicity of the Cuban vaccine against tetanus and diphtheria, VA-DIFTET, and the control vaccine D.T. VAX in children.
• Date of first enrolment: 08/05/2005
• Target sample size: 300
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000058-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: Dra Morelia Baró Suárez
• Affiliation: Finlay Institute

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

Key inclusion & exclusion criteria

Inclusion criteria: 1-A male or female between, and including, 5 and 7 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-Axillary temperature of >=37.5°C before vaccination.

Age minimum: 5 years
Age maximum: 7 years
Gender: Both

Health Condition(s) or Problem(s) studied

tetanus and diphtheria

Intervention(s)

The children were randomly distributed in two groups, respectively immunized with the candidate vaccine - VA-DIFTET -, or the control vaccine D.T.VAX, bivalent vaccines against tetanus and diphtheria. A single dose of 0,5 mL by intramuscular route was used. The study vaccine – VA-DIFTET – was developed by Finlay Institute and is composed of purified diphtheria toxoid (25 Lf) and purified tetanus toxoid (10 Lf). Aluminum hydroxide is used as adjuvant.

Primary Outcome(s)

Objectives: To evaluate the reactogenicity and immunogenicity of a single booster dose of VA-DIFTET, the Cuban vaccine against tetanus and diphtheria, and the control vaccine D.T.VAX, intramuscularly applied to children between 5 and 7 years of age. Endpoints: 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. Immunogenicity: 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. 3-Prevalence of suitable protective levels of tetanus antitoxin and diphtheria antitoxin >= 0,1 IU/mL 21 days after vaccination in relation to those levels detected before vaccination.

Secondary ID(s)

IF/DT/04

Source(s) of Monetary Support

Finlay Institute