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

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000049
• Date of registration: 29/07/2008
• Primary sponsor: Finlay Institute
• Public title: Post marketing clinical trial to evaluate the reactogenicity profile of the Cuban vaccine against diphtheria, tetanus, and pertussis infections in infants.
• 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.
• Date of first enrolment: 18/05/2004
• Target sample size: 57
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000049-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Placebo Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Jorge Menéndez Hernández
• Affiliation: Finlay Institute

• Name: Dra Maria Machado
• Affiliation: Finlay Institute

Key inclusion & exclusion criteria

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.

Age minimum: 2 months of age
Age maximum: 6 months of age
Gender: Both

Health Condition(s) or Problem(s) studied

tetanus, diphtheria, whooping cough

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.

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.

Secondary ID(s)

DTP -01-04

Source(s) of Monetary Support

Finlay Institute