A Phase II Prospective, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Influenza Vaccine GHB11L1 Administered Intranasally Against a Controlled Influenza Virus Challenge in Healthy Adults.

AVIR Green Hills Biotechnology Research Development Trade AG0 sites80 target enrollmentOctober 1, 2009

Overview

No summary available.

Registry

who.int

Start Date

October 1, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

AVIR Green Hills Biotechnology Research Development Trade AG

•1\. Male subjects aged 18 to 45 years.
•2\. In general good health determined by a screening evaluation \=45 days prior to
•double\-blind IMP administration and on the day of double\-blind IMP administration
•3\. Males should be willing to use a reliable form of contraception approved by the
•Investigator (use of a condom plus spermicide, or a female partner fulfilling the
•following criteria: hysterectomy or bilateral tubal ligation, oral or implanted
•contraceptive use, intrauterine device or barrier method plus spermicide) from
•immunisation phase baseline (Day \-28±2\) until 28 (±2\) days after the influenza
•4\. Negative human immunodeficiency virus (HIV), hepatitis B and C antibody screen
•5\. Negative drugs of abuse, alcohol and nicotine screen

•A complete list of exclusion criteria is given in the respective clinical study protocol:
•1\. Presence or evidence of significant acute or chronic, uncontrolled medical or
•psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated
•for \=3 months e.g. mild hypertension well\-controlled with medication, may be
•enrolled – provided the condition and its therapy are known not to be associated with an immunocompromised state or increased risks of complications of influenza)
•2\. Health care workers (including doctors, nurses, medical students and allied
•healthcare professionals) anticipated to have patient contact within two weeks of
•viral challenge. Healthcare workers who volunteer should not work with patients until
•14 days after challenge or until their symptoms are fully resolved (whichever is the
•longer). In particular, any health care workers who work in units housing severely