Reverse Genetic H9N2 Influenza Vaccine Study in Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 49
Updated:4/21/2016
Start Date:March 2011
End Date:May 2012

Use our guide to learn which trials are right for you!

A Randomized, Double Blind, Multi-center, Phase 1/2 Study to Assess Safety and Immunogenicity of Five Dose Levels of a Reverse Genetic (RG) Reassortant H9N2 Pandemic Influenza Vaccine in Healthy Subjects Aged 18 to 49 Years

The purpose of the study is to identify the optimal dose level of a reverse genetic (RG)
reassortant H9N2 pandemic influenza vaccine for further product development.


Inclusion Criteria:

- Subject is 18 to 49 years of age, inclusive, on the day of screening

- Subject has an understanding of the study and its procedures, agrees to its
provisions, and gives written informed consent prior to study entry

- Subject is generally healthy, as determined by the investigator's clinical judgement
through collection of medical history and performance of a physical examination

- Subject is physically and mentally capable of participating in the study as
determined by the investigator

- Subject agrees to keep a daily record of symptoms for the duration of the study

- If female of childbearing potential, subject presents with a negative urine pregnancy
test within 24 hours prior to first vaccination and agrees to employ adequate birth
control measures for the duration of the study. For the purposes of this study at
least one of the following types of US Food and Drug Administration (FDA) approved
birth control measures shall be applied through completion of the Day 181 study
visit:

- Hormonal types of birth control (such as implants or birth control pills) or an
intrauterine device

- A barrier type of birth control measure (i.e. condoms, diaphragms, cervical
caps, etc.)

Exclusion Criteria:

- Subject has a history of exposure to H9N2 influenza virus or a history of vaccination
with an H9N2 influenza vaccine

- Subject is at potential occupational risk of contracting H9N2 influenza infection
(e.g. poultry workers)

- Subject currently suffers from or has a history of a significant (requiring
hospitalization or change in intervention in past 6 months)neurological,
cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune,
hematological, metabolic or renal disorder such as but not limited to: multiple
sclerosis, lupus, Guillain-Barre syndrome as determined by the investigator

- Subject has a body temperature of >= 100.4 degrees Fahrenheit (>= 38.0 degrees
Celsius) on the day of vaccination, by oral measurement. [NOTE: Subjects meeting this
exclusion criterion may be rescheduled for vaccination and study entry at a later
date provided: 1) body temperature measured orally has decreased to < 100.4 degrees
Fahrenheit (< 38.0 degrees Celsius); 2) all other inclusion/exclusion criteria are
met; 3) the rescheduled date is no more than 14 days past the initial screening
assessments and date; and 4) the study site is still enrolling subjects and
randomization is not closed]

- Subject has a Body Mass Index (BMI) >= 35

- Subject has hypertension at screening that is graded as greater than Stage 1 (defined
as a systolic pressure > 159 or diastolic pressure > 99 while seated and at rest
(measurement shall be repeated twice before subject is excluded)

- Subject has clinically significant abnormal laboratory values at screening as
determined by the investigator

- Subject tests positive for Human Immunodeficiency Virus (HIV), Hepatitis B surface
Antigen (HBsAgs) or Hepatitis C Virus (HCV)

- Subject has any medically diagnosed or suspected immune deficient condition based on
medical history and physical examination as determined by the investigator

- Subject has an immune compromising condition or disease, or is currently undergoing a
form of treatment or was undergoing a form of treatment within 30 days prior to study
entry that can be expected to influence immune response. Such treatment includes, but
is not limited to, systemic or high dose inhaled (> 800 μg/day of beclomethasone
dipropionate or equivalent) corticosteroids, radiation treatment or other
immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be
permitted)

- Subject has a history of severe (required immediate medical life threatening
treatment and/or hospitalization) allergic reactions or anaphylaxis as determined by
the investigator

- Subject has a rash, dermatologic condition or tattoos which may interfere with
injection site reaction rating as determined by the investigator

- Subject has received any blood products (e.g. blood transfusion or immunoglobulins)
within 90 days prior to study entry

- Subject has donated one or more units of blood (approximately 450 mL) or plasma
within 30 days prior to study entry

- Subject has received any live vaccine within 4 weeks or an inactivated vaccine or a
subunit vaccine within 2 weeks prior to vaccination in this study

- Subject has a functional or surgical asplenia

- Subject has a positive urine drug screen (unless the subject is currently prescribed
the drug detected by a licensed health care provider and the continued administration
of the drug would not otherwise exclude the subject from participation)

- Subject has a known or suspected problem with alcohol or drug abuse as determined by
the investigator

- Subject is currently enrolled or has participated in another clinical study involving
an investigational products (IP) or device within 30 days prior to study enrollment
or is scheduled to participate in another clinical study involving an IP or device
during the course of this study

- Subject is a member of the team conducting this study or is in a dependent
relationship with one of the study team members. Dependent relationships include
close relatives (i.e. children, partner/spouse, siblings, parents) as well as
employees of the investigator or site personnel conducting the study

- If female, subject is pregnant or lactating at the time of study enrollment

- Any condition that in the opinion of the investigator would interfere with evaluation
of the vaccine or interpretation of study results
We found this trial at
5
sites
Melbourne, Florida 32935
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Huntsville, Alabama 35802
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Peoria, Illinois 61602
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
South Bend, Indiana 46601
?
mi
from
South Bend, IN
Click here to add this to my saved trials