Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:9/16/2018
Start Date:February 1, 2014
End Date:March 18, 2016

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

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine 792014 Compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Vaccine in Healthy Infants and Toddlers

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK
Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and
Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in
infants and toddlers.


Inclusion Criteria:

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

- A male or female between, and including, 6 and 12 weeks of age at the time of the
first vaccination.

- Written informed consent obtained from the parent(s)/LAR(s) of the subject.

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

- Born full-term (i.e. born after a gestation period of at least 37 weeks inclusive).

- Infants who have not received a previous dose of hepatitis B vaccine or those who have
received only 1 dose of hepatitis B vaccine administered at least 30 days prior to
enrollment.

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the dose of study vaccine or planned use
during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs since
birth prior to the first vaccine dose. Inhaled and topical steroids are allowed.

- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b,
diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or
poliovirus; more than one previous dose of hepatitis B vaccine.

- Planned administration/administration of a vaccine not foreseen by the study protocol
in the period starting 30 days before and ending 30 days after the dose of vaccines.
Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any
time during the study according to the national recommendation. Measles, mumps,
rubella and varicella vaccination are allowed 30 days before or 30 days after the
final vaccination of Hib-MenCY-TT or PedvaxHIB.

- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus,
pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus
disease.

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

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines, including dry natural latex rubber. Hypersensitivity to any component of
the vaccines, including gelatin or neomycin.

- Major congenital defects or serious chronic illnesses.

- History of any neurologic disorders or seizures. A single, simple febrile seizure is
allowed.

- Subjects with history of intussusceptions or uncorrected congenital malformation of
the gastrointestinal tract that would predispose for intussusceptions.

- Acute disease and/or fever at the time of enrollment.

- Administration of immunoglobulins and/or blood products since birth or planned
administration during the study period.
We found this trial at
26
sites
Jonesboro, Arkansas 72401
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Dayton, Ohio 45420
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Fresno, California 93720
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Hermitage, Pennsylvania 16148
?
mi
from
Hermitage, PA
Click here to add this to my saved trials
Huntington Beach, California 92647
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Layton, Utah 84041
?
mi
from
Layton, UT
Click here to add this to my saved trials
Murray, Utah 84107
?
mi
from
Murray, UT
Click here to add this to my saved trials
Niles, Michigan 49120
?
mi
from
Niles, MI
Click here to add this to my saved trials
Orem, Utah 84058
?
mi
from
Orem, UT
Click here to add this to my saved trials
Paramount, California 90723
?
mi
from
Paramount, CA
Click here to add this to my saved trials
Pleasanton, California 94588
?
mi
from
Pleasanton, CA
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
Roseville, California 95678
?
mi
from
Roseville, CA
Click here to add this to my saved trials
Roy, Utah 84067
?
mi
from
Roy, UT
Click here to add this to my saved trials
Sacramento, California 95815
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Jose, California 95116
?
mi
from
San Jose, CA
Click here to add this to my saved trials
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
Stevensville, Michigan 49127
?
mi
from
Stevensville, MI
Click here to add this to my saved trials
Syracuse, Utah 84075
?
mi
from
Syracuse, UT
Click here to add this to my saved trials
Walnut Creek, California 94596
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
Woburn, Massachusetts 01801
?
mi
from
Woburn, MA
Click here to add this to my saved trials