A phase II study of the Cuban adult formulation tetanus and diphtheria vaccine.
- Conditions
- tetanus and diphtheriaTetanusDiphtheriaClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsCorynebacterium InfectionsActinomycetales Infections
- Registration Number
- RPCEC00000059
- Lead Sponsor
- Finlay Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 225
1-A male or female over, and including, 13 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.
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-Pregnancy or breastfeeding. 8-Axillary temperature of >=37.5°C before vaccination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method