Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants



Status:Completed
Conditions:Influenza, Pneumonia, Vaccines, Infectious Disease, Orthopedic, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:7/14/2018
Start Date:June 18, 2010
End Date:July 17, 2013

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Phase III, Partially Double-blind Study to Evaluate Consistency and Immunogenicity of 3 Lots of GSK Biologicals' Hib Conjugate Vaccine 208108 Versus ActHIB and Pentacel at 2, 4, 6 and 15-18 Months of Age in Healthy Infants

The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the
vaccine, to address the relevant concomitant vaccine administrations and to provide a
comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib
vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and
15-18 months of age. This study is designed with a primary and a booster phase.

This protocol posting has been updated following protocol amendment 3, dated 12 April 2011.
The impacted section is: Eligibility Criteria (Exclusion criteria).

Inclusion Criteria:

- Subjects for whom the investigator believes that their parent(s)/Legally Acceptable
Representative(s) (LAR[s]) can and will comply with the requirements of the protocol
(e.g., completion of the diary card, return for follow-up visits).

- 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 subject's parent/LAR.

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

- Born after a gestation period of minimum 36 weeks.

- 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:

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

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth.

- Planned administration of a vaccine not foreseen by the study protocol within 30 days
of the first dose of study vaccine and until 30 days after the booster dose.

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

- History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis,
pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.

- 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.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at time of enrollment. All vaccines can be administered to persons with
a minor illness.

- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.

- Concurrent participation in another clinical study, up to 30 days prior to study entry
or at any time during the study period, in which the subject has been or will be
exposed to an investigational or a non-investigational product (pharmaceutical product
or device).

- Child in care.

- History of intussusception.

- History of uncorrected congenital malformation of the gastrointestinal tract that
would predispose the infant to intussusception.

- History of Severe Combined Immunodeficiency Disease.
We found this trial at
62
sites
Erie, Pennsylvania 16507
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Amarillo, Texas 79106
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Anaheim, California 92807
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Antioch, California 94509
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Bardstown, Kentucky 40004
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Benton, Arkansas 72019
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Boulder, Colorado 80304
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Bountiful, Utah 84010
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Canton, Ohio 44708
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Canton, OH
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Charleston, South Carolina 29425
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Charleston, SC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Cleveland, Ohio 44195
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Colorado Springs, Colorado 80910
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Daly City, California 94015
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Daly City, CA
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Dayton, Ohio 45420
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Dayton, OH
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Dothan, Alabama 36305
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Dothan, AL
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Fall River, Massachusetts 02720
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Fall River, MA
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Fargo, North Dakota 58122
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Fargo, ND
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Fayetteville, Arkansas 72703
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Fayetteville, AR
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Fort Worth, Texas 76104
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Fountain Valley, California 92708
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Fountain Valley, CA
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Fremont, California 94538
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Fresno, California 93720
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Greenville, Pennsylvania 16125
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Greenville, PA
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Hayward, California 94545
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Hermitage, Pennsylvania 16148
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Hermitage, PA
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Honolulu, Hawaii 96813
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Honolulu, HI
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Houston, Texas 77030
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Houston, TX
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Huntington Beach, California 92647
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Jonesboro, Arkansas 72401
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Layton, Utah 84041
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Little Rock, Arkansas 72205
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Louisville, Kentucky 40202
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Madison, Wisconsin 53792
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Marietta, Georgia 30060
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Marshfield, Wisconsin 54449
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Mineola, New York 11501
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Nampa, Idaho 83686
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Nampa, ID
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Oakland, California 94611
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Omaha, Nebraska 68131
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Orange City, Florida 32763
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Redwood City, California 94063
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Roseville, California 95678
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Roy, Utah 84067
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Sacramento, California 95815
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Saint Paul, Minnesota 55101
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Salt Lake City, Utah 84132
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San Jose, California 95116
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San Jose, CA
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Santa Clara, California 95051
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Santa Rosa, California 95403
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South Jordan, Utah 84095
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Stevensville, Michigan 49127
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Sugar Land, Texas 77479
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Syracuse, New York 13210
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Syracuse, Utah 84075
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Tulsa, Oklahoma 74105
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Utica, New York 13502
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Vallejo, California 94589
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Waipio, Hawaii 96797
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Walnut Creek, California 94596
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West Covina, California 91790
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Woodstock, Georgia 30189
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