RPCEC00000058
Completed
Phase 2
A phase II, double-blind, randomized, controlled study to evaluate the reactogenicity and immunogenicity of the Cuban vaccine against tetanus and diphtheria, VA-DIFTET, and the control vaccine D.T. VAX in children.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- tetanus and diphtheria
- Sponsor
- Finlay Institute
- Enrollment
- 300
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\-A male or female between, and including, 5 and 7 years of age at the time of the 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\-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs prior to the vaccination. Inhaled and topical steroids are allowed. 2\-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. 3\-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 4\-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 5\-History of any neurological disorders or seizures. 6\-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 7\-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. 8\-Axillary temperature of \>\=37\.5°C before vaccination.
Outcomes
Primary Outcomes
Not specified
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