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

NCT ID: NCT00751348

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-01
• Study Completion Date: 2010-05-27

Brief Summary

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

Conditions

Measles; Varicella; Mumps; Rubella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Priorix-Tetra®

Intervention Type: BIOLOGICAL

Subcutaneous injection in left upper arm

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.

Group Type: ACTIVE_COMPARATOR

PriorixTM

Intervention Type: BIOLOGICAL

Subcutaneous administration in left upper arm

VarilrixTM

Intervention Type: BIOLOGICAL

Subcutaneous administration in right upper arm

Interventions

PriorixTM

Subcutaneous administration in left upper arm

Intervention Type: BIOLOGICAL

VarilrixTM

Subcutaneous administration in right upper arm

Intervention Type: BIOLOGICAL

Priorix-Tetra®

Subcutaneous injection in left upper arm

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 11 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bucheon-si, , South Korea

GSK Investigational Site

Daejeon, , South Korea

GSK Investigational Site

Gwangju, , South Korea

GSK Investigational Site

GyeongSangNam-do, , South Korea

GSK Investigational Site

Iksan, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Jeonju Jeonbuk, , South Korea

GSK Investigational Site

Seongnam-si, Gyeonggi-do, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Uijeongbu, Kyonggi-do, , South Korea

GSK Investigational Site

Wonju-si Kangwon-do, , South Korea

Countries

South Korea

References

Cha SH, Shin SH, Lee TJ, Kim CH, Povey M, Kim HM, Nicholson O. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine: an open-labeled, randomized trial in healthy Korean children. Clin Exp Vaccine Res. 2014 Jan;3(1):91-9. doi: 10.7774/cevr.2014.3.1.91. Epub 2013 Dec 18.

Reference Type: BACKGROUND

PMID: 24427766 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Informed Consent Form

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

110876

Identifier Type: -

Identifier Source: org_study_id