Vaccine Clinical Trial
Official title:
A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers
The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI) - Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG. - Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission. Exclusion Criteria: - History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption. - Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing - Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Quintiles Drug Research Unit | London |
Lead Sponsor | Collaborator |
---|---|
BTG International Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Events | Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event. | Duration of study | Yes |
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