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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01015703
Other study ID # PR002-CLN-pro010
Secondary ID
Status Completed
Phase Phase 1
First received November 17, 2009
Last updated September 9, 2014
Start date November 2009
Est. completion date June 2010

Study information

Verified date September 2014
Source BTG International Inc.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Biological:
CoVaccine HT
intramuscular injection, dose escalation

Locations

Country Name City State
United Kingdom Quintiles Drug Research Unit London

Sponsors (1)

Lead Sponsor Collaborator
BTG International Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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