Loading clinical trials...

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)

NCT01621802•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

Detailed Description

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv\_MMR vaccine and Com\_MMR vaccine respectively. 2 lots of the comparator vaccine (Com\_MMR\_L1 and Com\_MMR\_L2) will be used, but the 2 lots will be analysed as a pool. The Inv\_MMR vaccine will be administered as a second dose to children who already received a first dose Com\_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.

Eligibility

Age

4 - 6 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
•Male or female subjects 4 to 6 years of age at the time of vaccination.
•Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
•Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
•Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
•For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:
•* subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
•* subjects received a first dose of VV in the second year of life.

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 day of study vaccination/s or planned during the entire study period.
•Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
•Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and 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 before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
•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, and/or rubella disease.
•Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
+15 more criteria

Locations (67)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Benton, Arkansas, United States

GSK Investigational Site

Fayetteville, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Baldwin Park, California, United States

GSK Investigational Site

Daly City, California, United States

GSK Investigational Site

Fresno, California, United States

Key Dates

Start Date

June 21, 2012

Primary Completion Date

July 6, 2015

Completion Date

November 9, 2015

Last Updated

November 25, 2019

Enrollment

4,011

ACTUAL participants

Conditions

Measles-Mumps-Rubella

Interventions

Priorix

BIOLOGICAL

M-M-R II

BIOLOGICAL

Kinrix

BIOLOGICAL

ProQuad

BIOLOGICAL