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

Measles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751348
• Other study ID #: 110876
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2008
• Est. completion date: May 27, 2010

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: May 27, 2010
• Est. primary completion date: May 27, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• PriorixTM
Subcutaneous administration in left upper arm
• VarilrixTM
Subcutaneous administration in right upper arm
• Priorix-Tetra®
Subcutaneous injection in left upper arm

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Bucheon-si,
Korea, Republic of	GSK Investigational Site	Daejeon
Korea, Republic of	GSK Investigational Site	Gwangju
Korea, Republic of	GSK Investigational Site	GyeongSangNam-do
Korea, Republic of	GSK Investigational Site	Iksan
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Jeonju Jeonbuk
Korea, Republic of	GSK Investigational Site	Seongnam-si, Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Uijeongbu, Kyonggi-do
Korea, Republic of	GSK Investigational Site	Wonju-si Kangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values	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.	At 42 days post-vaccination
Secondary	Antibody Concentrations Against Measles	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).	At 42-days post-vaccination
Secondary	Antibody Concentrations Against Mumps	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).	At 42-days post-vaccination
Secondary	Antibody Concentrations Against Rubella	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).	At 42-days post-vaccination
Secondary	Antibody Titers Against Varicela Viruses	Antibody titers were presented as geometric mean titers (GMTs).	At 42-days post-vaccination
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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.	During the 4-day (Days 0-3) post-vaccination period
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	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.	During the 43-day (Days 0-42) post-vaccination period
Secondary	Number of Subjects With Any Unsolicited Adverse Events (AEs)	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.	Within the 43-day (Days 0-42) post-vaccination period
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	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.	During the entire study period (from Day 0 up to Day 43 or Day 57)

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