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Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00751348
First received: September 10, 2008
Last updated: May 4, 2017
Last verified: March 2017
  Purpose
This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.

Condition Intervention Phase
Measles Varicella Mumps Rubella Biological: PriorixTM Biological: VarilrixTM Biological: Priorix-Tetra® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values [ Time Frame: At 42 days post-vaccination ]
    Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.


Secondary Outcome Measures:
  • Antibody Concentrations Against Measles [ Time Frame: At 42-days post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  • Antibody Concentrations Against Mumps [ Time Frame: At 42-days post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).

  • Antibody Concentrations Against Rubella [ Time Frame: At 42-days post-vaccination ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

  • Antibody Titers Against Varicela Viruses [ Time Frame: At 42-days post-vaccination ]
    Antibody titers were presented as geometric mean titers (GMTs).

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]
    Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within the 43-day (Days 0-42) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 up to Day 43 or Day 57) ]
    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 475
Study Start Date: October 1, 2008
Study Completion Date: May 27, 2010
Primary Completion Date: May 27, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRIORIX-TETRA GROUP
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
Biological: Priorix-Tetra®
Subcutaneous injection in left upper arm
Active Comparator: PRIORIX + VARILRIX GROUP
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
Biological: PriorixTM
Subcutaneous administration in left upper arm
Biological: VarilrixTM
Subcutaneous administration in right upper arm

  Eligibility

Ages Eligible for Study:   11 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • History of measles, mumps, rubella and/or varicella/zoster diseases.
  • Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination.
  • Residence in the same household as a high risk person e.g.:

    • New-born infants (0-4 weeks of age)
    • Pregnant women who have a negative history of chickenpox
    • Persons with known immunodeficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751348

Locations
Korea, Republic of
GSK Investigational Site
Bucheon-si,, Korea, Republic of, 420-767
GSK Investigational Site
Daejeon, Korea, Republic of, 301-723
GSK Investigational Site
Gwangju, Korea, Republic of, 501-717
GSK Investigational Site
GyeongSangNam-do, Korea, Republic of, 641-560
GSK Investigational Site
Iksan, Korea, Republic of, 570-711
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
GSK Investigational Site
Seoul, Korea, Republic of, 150-950
GSK Investigational Site
Uijeongbu, Kyonggi-do, Korea, Republic of, 480-130
GSK Investigational Site
Wonju-si Kangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Sung-Ho Cha et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella (MMRV) vaccine: an open-labeled, randomized trial in healthy Korean children. Abstract presented at the Fall Meeting of Korean Vaccine Society (KVS). Seoul, Korea, 31 August 2013.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110876
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110876
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110876
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110876
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110876
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110876
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00751348     History of Changes
Other Study ID Numbers: 110876
Study First Received: September 10, 2008
Results First Received: March 13, 2017
Last Updated: May 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
second year of life
one-dose schedule
varicella
rubella
measles
mumps

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Rubella
Mumps
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017