Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
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ClinicalTrials.gov Identifier: NCT00751348 |
Recruitment Status
:
Completed
First Posted
: September 11, 2008
Results First Posted
: April 24, 2017
Last Update Posted
: June 5, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Measles Varicella Mumps Rubella | Biological: PriorixTM Biological: VarilrixTM Biological: Priorix-Tetra® | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 475 participants |
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 |
Study Start Date : | October 1, 2008 |
Actual Primary Completion Date : | May 27, 2010 |
Actual Study Completion Date : | May 27, 2010 |

Arm | Intervention/treatment |
---|---|
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.
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Biological: Priorix-Tetra®
Subcutaneous injection in left upper arm
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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.
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Biological: PriorixTM
Subcutaneous administration in left upper arm
Biological: VarilrixTM
Subcutaneous administration in right upper arm
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- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 11 Months to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751348
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00751348 History of Changes |
Other Study ID Numbers: |
110876 |
First Posted: | September 11, 2008 Key Record Dates |
Results First Posted: | April 24, 2017 |
Last Update Posted: | June 5, 2017 |
Last Verified: | March 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 |