Study of the tetanus vaccine vax-TET®-5

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:

Controlled, randomized and double-blind study to assess the immunogenicity and reactogenicity of a supporting dose of the TETANUS vaccines vax-TET®-5 under study and vax-TET® used as a control, administered in adolescents.

Secondary indentifying numbers:

IF/vax-TET®-5/01

Issuing authority of the secondary identifying numbers:

Finlay Institute, Center of Research and Production of Vaccines.

Source(s) of monetary or material support:

Finlay Institute, Center of Research and Production of Vaccines.

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 :

02/02/2010

Reference number:

24-155-09-B

Principal investigator

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

First name:

Lazaro Manuel Aguila Quevedo, MD, First degree especialist in health administration

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

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

Research ethics committees:

Research Ethics Committee of “Victoria de Girón” Basic and Preclinical Sciences Institute. 2010-01-12 (aaaa-mm-dd). (Research Ethics Committee of the study)

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

15/04/2010

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

Intervention(s):

Study group (Experimental cuban vaccine): vax-TET®-5 tetanus vaccine. Single dose of 0.5ml by intramuscular deep inyecction Control group (vaccine): vax-TET® tetanus vaccine. Single dose of 0.5ml by intramuscular deep injection

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):

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.

Key secondary outcomes:

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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

13 years

Maximum age:

15 years

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.

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:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

472

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:

Lazaro

Middle Name:

Manuel

Last Name:

Aguila Quevedo

Affiliation:

Provincial Health Management of Artemisa.

Postal Address:

Ave.152, No 24914, % 249 and 250.

City:

Bauta

Country:

Cuba

Zip Code:

32400

Telephone:

(53) 047 366511-13

Email :

epidehab@infomed.sld.cu [2]

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:

Idalia

Middle Name:

Morelia

Last Name:

Baro Suarez

Affiliation:

Finlay Institute, Center of Research and Production of Serum and Vaccines.

Postal Address:

Ave 27, Not.19805, La Lisa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 2716553, (537) 2716557

Email :

mbaro@finlay.edu.cu [3]

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:

RPCEC00000156

Date of Registration in Primary Registry:

2013-06-10

Record Verification Date:

2013-06-06

Next update date:

2014-06-06

Link to the spanish version:

Click here [4]