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

Phase 4

Conditions: tetanus, diphtheria, whooping cough
Diphtheria
Tetanus
Whooping Cough
Corynebacterium Infections
Actinomycetales Infections
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections

Registration Number: RPCEC00000049

Lead Sponsor: Finlay Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 57

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures