Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV



Status:Not yet recruiting
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:1/6/2019
Start Date:April 1, 2019
End Date:March 9, 2022
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Infants

The purpose of this study is to provide critical information on the safety, reactogenicity
and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type
155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV, and will
assess a single lower dose and a higher two dose regimen, before moving to future studies.
This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease'
after vaccination of these infants with the ChAd155-RSV vaccine.

The RSV PED-011 study was designed to evaluate the safety, reactogenicity and immunogenicity
of the RSV candidate vaccine when administered to infants aged 6 and 7 months before moving
to a proof-of-concept trial in infants. The ChAd155-RSV vaccine will be administered before
the RSV season to increase the probability of enrolling infants unexposed to RSV, who will be
followed through two RSV seasons. For the 2 dose groups, the second dose of ChAd155-RSV
vaccine will be given one month after the first dose. Approximately two thirds of the infants
(100) in this study will be given the ChAd155-RSV vaccine, whereas all infants (150) will
receive either an active control comparator vaccine (Bexsero, or Nimenrix, or Synflorix, or
Menveo), or Placebo (Formulation buffer S9b). After a screening visit lasting up to 30 days
(Epoch 1), this study will be conducted in an observer-blind manner, during the 2 month
vaccination phase (Epoch 2) and in a single-blinded manner during the follow-up phase, for 10
months until the end of the first RSV season (Epoch 3) and then for an additional follow-up
year, until the end of the second RSV season (Epoch 4).

Inclusion Criteria:

- Subjects' parent(s)/Legally Acceptable Representative [LAR(s)] who, in the opinion of
the investigator, can and will comply with the requirements of the protocol

- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
performing any study specific procedure.

- A male or female between and including 6 and 7 months of age (from the day the infant
becomes 6 months of age until the day before the infant achieves 8 months of age) at
the time of the first vaccination.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Born full-term with a minimum birth weight of 2.5 kilograms (kg).

- Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone
contact or computer.

Exclusion Criteria:

- Child in care

- Use of any investigational or non-registered product other than the study vaccine
during the period starting 30 days before the first dose of study vaccine (Day -29 to
Day 1), or planned use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs during
the period starting six months prior to the first vaccine. For corticosteroids, this
will mean prednisone ≥ 0.5 milligrams (mg)/kg/day (for pediatric subjects), or
equivalent. Topical steroids are allowed.

- Administration of long-acting immune-modifying drugs or planned administration at any
time during the study period.

- Administration of immunoglobulins and/or any blood products during the period starting
three months before the first dose of study vaccine or planned administration during
the study period.

- Planned administration/administration of a vaccine not foreseen by the study protocol
in the period starting 30 days before the first dose and ending 30 days after the last
dose of vaccine administration, with the exception of scheduled routine pediatric
vaccines. Scheduled routine pediatric vaccines may be administered ≥ 7 days before a
dose of study vaccine or ≥ 7 days following a dose of study vaccine, with the
exception of live viral vaccines which may be administered ≥ 14 days before a dose or
≥ 7 days after a dose.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.

- A history of, or on-going confirmed RSV disease or highly compatible clinical picture.

- Serious chronic illness.

- Major congenital defects.

- History of any neurological disorders or seizures.

- History of or current autoimmune disease.

- History of recurrent wheezing.

- History of chronic cough.

- Previous hospitalization for lower respiratory illnesses.

- Previous, current or planned administration of Synagis (palivizumab).

- Neurological complications following any prior vaccination.

- Born to a mother known or suspected to be Human Immunodeficiency Virus (HIV)-positive
.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination .

- Family history of congenital or hereditary immunodeficiency.

- Previous vaccination with a recombinant simian or human adenoviral vaccine.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine.

- Hypersensitivity to latex.

- Current severe eczema.

- Acute disease and/or fever at the time of enrolment (Visit 1).

- Any clinically significant Grade 1 or any ≥ Grade 2 hematological or biochemical
laboratory abnormality detected at the last screening blood sampling.

- Any medical condition that in the judgment of the investigator would make
intramuscular (IM) injection unsafe.

- Any other conditions that the investigator judges may interfere with study procedures,
findings.

- Any conditions that could constitute a risk for the subjects while participating to
this study.

- Weight below the fifth percentile of the local weight-for-age curve.

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject or mother has been or will be exposed to an
investigational or a non-investigational vaccine/product.

- Planned move to a location that will prohibit participating in the trial until study
end.

- For Thailand only, subjects who have received Synflorix prior to enrolment.
We found this trial at
26
sites
Roy, Utah 84067
Phone: 877-379-3718
?
mi
from
Roy, UT
Click here to add this to my saved trials
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Atlanta, Georgia 30341
Phone: 877-379-3718
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21201
Phone: 877-379-3718
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boone, North Carolina 28607
?
mi
from
Boone, NC
Click here to add this to my saved trials
Charleston, South Carolina 29425
Phone: 877-379-3718
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cleveland, Ohio 44195
Phone: 877-379-3718
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Fall River, Massachusetts 02720
Phone: 877-379-3718
?
mi
from
Fall River, MA
Click here to add this to my saved trials
Kaysville, Utah 84037
Phone: 877-379-3718
?
mi
from
Kaysville, UT
Click here to add this to my saved trials
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Layton, Utah 84041
Phone: 877-379-3718
?
mi
from
Layton, UT
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 877-379-3718
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Miami Lakes, Florida 33014
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Murray, Utah 84107
Phone: 877-379-3718
?
mi
from
Murray, UT
Click here to add this to my saved trials
Nampa, Idaho 83686
Phone: 877-379-3718
?
mi
from
Nampa, ID
Click here to add this to my saved trials
North Charleston, South Carolina 29456
?
mi
from
North Charleston, SC
Click here to add this to my saved trials
Paducah, Kentucky 42001
?
mi
from
Paducah, KY
Click here to add this to my saved trials
Provo, Utah 84604
Phone: 877-379-3718
?
mi
from
Provo, UT
Click here to add this to my saved trials
Raleigh, North Carolina 27614
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23298
Phone: 877-379-3718
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Sioux Falls, South Dakota 57108
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Syracuse, New York 13210
Phone: 877-379-3718
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tomball, Texas 77375
Phone: 877-379-3718
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Topeka, Kansas 66604
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Villanueva- Guaymallen, Mendoza
Phone: 877-379-3718
?
mi
from
Villanueva- Guaymallen,
Click here to add this to my saved trials
Warwick, Rhode Island 02888
Phone: 877-379-3718
?
mi
from
Warwick, RI
Click here to add this to my saved trials