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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

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.

Secondary indentifying numbers:

IF/DT/04

Issuing authority of the secondary identifying numbers:

Finlay Institute

Source(s) of monetary or material support:

Finlay Institute

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

03/05/2005

Reference number:

940/05.015.05B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Katiuska

Last name:

Fernandez Jerez

Medical Specialty :

Specialist in Epidemiology

Affiliation:

Provincial Center of Hygiene and Epidemiology.

Postal address:

Ave 31 no. 7617 entre 76 y 82. Marianao

City:

Havana

Country:

Cuba

Zip Code:

11400

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Six elementary schools of “10 de Octubre” municipality, Dra. Katiuska Fernandez Jerez. Specialist in Epidemiology.

Research ethics committees:

Basic Science Institute ''Victoria de Giron''. Havana. April 1, 2005.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

08/05/2005

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

tetanus and diphtheria

Health condition(s) code:

Tetanus

Diphtheria

Clostridium Infections

Gram-Positive Bacterial Infections

Bacterial Infections

Corynebacterium Infections

Actinomycetales Infections

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.

Intervention code:

Diphtheria-Tetanus Vaccine

Vaccines

Injections, Intramuscular

Intervention keyword:

VA-DIFTET, D.T.VAX

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

Not Applicable

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

5 years

Maximum age:

7 years

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.

Type of population:

Children

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

300

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Morelia

Last Name:

Baró Suárez

Affiliation:

Finlay Institute

Postal Address:

Ave 27, No 19805, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

72731218

Email :

mbaro@finlay.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Rolando

Last Name:

Ochoa Azze

Affiliation:

Finlay Institute

Postal Address:

Ave 27, No 19805, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

72731218

Email :

ochoa@finlay.edu.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000058

Date of Registration in Primary Registry:

2008-07-29

Record Verification Date:

2008-07-28 20:00

Link to the spanish version:

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

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