tetanus, diphtheria, whooping cough
Conditions
Interventions
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 diphtheria
Diphtheria-Tetanus-Pertussis Vaccine
Vaccines
Sponsors
Finlay Institute
Eligibility
Sex/Gender
All
Age
2 Months to 6 Months
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactMaria Machado
Finlay Institute
Outcome results
None listed