Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:7 - Any
Updated:6/7/2018
Start Date:July 1, 2014
End Date:September 17, 2015

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

Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR
(Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the
US.

This study will evaluate the immunogenicity of GSK's trivalent MMR vaccine (referred to as
INV_MMR vaccine) in contrast to the US standard of care (M-M-R®II, Merck and Company,
referred to as COM_MMR) when both are used as a second dose in subjects 7 years of age and
older. In this study, the INV_MMR vaccine may be administered as a second dose to persons
with either a history or formal documentation of at least one dose immunization with any MMR
vaccine. This study is intended to support licensure of GSK's MMR vaccine in the US.

Inclusion Criteria:

- Subjects who the investigator believes that they and/or their parent(s) or Legally
Acceptable Representative(s) (LAR) can and will comply with the requirements of the
protocol.

- Male or female subjects 7 years of age or older and born after December 31, 1956*.
*The only exception to this is health care workers born before 1957 without other
evidence of immunity to mumps for which one dose of a live mumps virus vaccine is
recommended; therefore this population is eligible for enrollment in this study.

- For all children 7-17 years of age:

- Written documentation of prior receipt of 1 dose of MMR vaccine administered on
or after the first birthday.

- For all adults 18 years of age and older:

- Prior receipt (written or verbal history) of at least one dose of MMR vaccine.

- Birth in the US.

- Written informed consent obtained from the subject or from the parent(s)/LAR(s) of the
subject (assent will be obtained from subjects who are still legally minors in line
with local rules and regulations).

- Subjects in stable health as determined by investigator's physical examination and
assessment of subjects' medical history.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, or ovariectomy or post-menopause.

- Female subjects of childbearing potential may be enrolled in the study, if the subject

- Has agreed to be abstinent or practiced adequate contraception during the entire
period starting 30 days prior to vaccination(s) until 3 months after receipt of
the study vaccination and

- has a negative pregnancy test on the day of vaccination.

Exclusion Criteria:

- Child in care.

- For all children 7-17 years of age:

- Previous receipt of more than 1 dose of a measles-containing vaccine.

- Use of any investigational or non-registered product other than the study vaccine(s),
during the period starting 30 days preceding the day of study vaccination, (i.e. 30
days prior to Day 0) or planned use during the entire study period.

- Receipt of any measles, mumps or rubella-containing vaccine during the period starting
42 days before the day of study vaccination (i.e. 42 days prior to Day 0).

- Chronic administration (defined as 14 or more consecutive days) of immunosuppressants
or other immune-modifying drugs during the period starting 180 days before study
vaccination or any planned administration of immune-modifying drugs during the entire
study. Inhaled and topical steroids are allowed.

- Administration of immunoglobulins and/or any blood products during the period starting
180 days prior to study vaccination through the immunogenicity evaluation at Visit 2
or Visit 3 (for one-dose or two-dose cohort, respectively).

- Planned administration/ administration of any live viral vaccine not foreseen by the
study protocol during the period starting 30 days prior to study vaccination and
ending at Visit 2. Live intranasal influenza vaccine or any inactivated vaccine
required in the age group may be given at any time, including the day of study
vaccination.

- Concurrently participating in another clinical study, 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.

- History of measles, mumps, or rubella disease.

- Known exposure to measles, mumps, or rubella, during the period starting 30 days
before study start (i.e. 30 days prior to Day 0).

- %
We found this trial at
11
sites
Chicago, Illinois 60611
?
mi
from
Chicago, IL
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
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Mesa, Arizona 85206
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78258
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Tartu,
Click here to add this to my saved trials