A phase II study of the Cuban vaccine against tetanus and diphtheria VA-DIFTET.

Phase 2

• Conditions: tetanus and diphtheria; Diphtheria; Gram-Positive Bacterial Infections; Tetanus; Clostridium Infections; Corynebacterium Infections; Actinomycetales Infections; Bacterial Infections

• Registration Number: RPCEC00000058
• Lead Sponsor: Finlay Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified