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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: Priorix-Tetra®; Biological: VarilrixTM; Biological: PriorixTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751348

110876

Details and patient eligibility

About

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

Enrollment: 475 patients

Sex: All

Ages: 11 to 24 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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475 participants in 2 patient groups

PRIORIX-TETRA GROUP

Experimental group

Description:

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.

Treatment:

Biological: Priorix-Tetra®

PRIORIX + VARILRIX GROUP

Active Comparator group

Description:

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.

Treatment:

Biological: PriorixTM

Biological: VarilrixTM