Post marketing clinical trial to evaluate the reactogenicity profile of the Cuban vaccine against diphtheria, tetanus, and pertussis infections in infants.

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:

Clinical trial to evaluate the reactogenicity profile of the Cuban trivalent vaccine against diphtheria, tetanus and pertussis infections in infants, during its application in the National Program of Immunizations.

Secondary indentifying numbers:

DTP -01-04

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 :

17/05/2004

Reference number:

24-026-04-B

Principal investigator

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

First name:

Telma .

Midle name:

Maria

Last name:

Triana Rodriguez

Medical Specialty :

Specialist I Degree in Epidemiology

Affiliation:

Provincial Center of Hygiene and Epidemiology

Postal address:

Calle 51 e/ 122 y 124

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72650922

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; 37 physician consultation of the Polyclinic "Finlay" in the Marianao Municipality. Dra. Telma Maria Triana Rodriguez. Specialist in Epidemiology. Provincial Center of Hygiene and Epidemiology.

Research ethics committees:

Basic Science Institute ''Victoria de Giron''. Havana City. April 13, 2004.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

18/05/2004

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, diphtheria, whooping cough

Health condition(s) code:

Diphtheria

Tetanus

Whooping Cough

Corynebacterium Infections

Actinomycetales Infections

Clostridium Infections

Gram-Positive Bacterial Infections

Bacterial Infections

Bordetella Infections

Respiratory Tract Infections

Respiratory Tract Diseases

Intervention(s):

Three doses of 0,5 mL each of the Cuban DTP vaccine are applied at 2, 4 and 6 months of age. The Cuban DTP vaccine is composed by purified diphtheria toxoid, obtained of the Corynebacterium diphtheriae Park Williams #8 strain, purified tetanus toxoid, obtained of the Clostridium tetani Harvard strain, and inactivated Bordetella pertussis cells. DTP vaccine is adsorbed in aluminum hydroxide that is used as adjuvant.

Intervention code:

Diphtheria-Tetanus-Pertussis Vaccine

Vaccines

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):

Objective: To evaluate the reactogenicity of the Cuban trivalent vaccine against diphtheria, tetanus and pertussis infections in infants, during its application in the National Program of Immunizations. 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.

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:

2 months

Maximum age:

6 months

Inclusion criteria:

1-A male or female infant of 2, 4, and 6 months of age that requires the first, second or third doses of DTP vaccine according to the planned schedule of 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-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. 2-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 3-Axillary temperature of >=37.5°C before vaccination. 4-History of any neurological disorders, seizures or hypotonic hyporesponsiveness episode. 5-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 6-Premature infant. 7-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 8-A family history of congenital immunodeficiency. 9-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.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Placebo

Study design:

Single group

Phase:

4

Target sample size:

57

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:

Maria

Middle Name:

de los Angeles

Last Name:

Machado

Affiliation:

Finlay Institute

Postal Address:

Ave 27, No 19805, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

72731218

Email :

mpena@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:

Jorge

Last Name:

Menendez Hernandez

Specialty:

Specialist I Degree in Epidemiology

Affiliation:

Finlay Institute

Postal Address:

Ave 27, No 19805, La Lisa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

72731218

Email :

jmenendez@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:

RPCEC00000049

Date of Registration in Primary Registry:

2008-07-29

Record Verification Date:

2008-07-29 20:00

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Post marketing clinical trial to evaluate the reactogenicity profile of the Cuban vaccine against diphtheria, tetanus, and pertussis infections in infants.

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