Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

GlaxoSmithKline450 enrolled

Overview

The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

450

Conditions

Varicella Rubella Mumps Measles

Interventions

GSK Biological's investigational MMRV vaccine 208136BIOLOGICAL

Subcutaneous injection

Priorix™BIOLOGICAL

Subcutaneous injection

Varilrix™BIOLOGICAL

Subcutaneous injection

Eligibility

Sex: ALLMin age: 9 MonthsMax age: 10 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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. * Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination. * Written informed consent obtained from the 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 other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine . * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product. * Previous vaccination against measles, mumps, rubella and varicella. * History of measles, mumps, rubella and/or varicella diseases. * Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Axillary temperature \> 37.5°C (99.5°F) / Rectal temperature \> 38°C (100.4°F). * Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * Presence of a susceptible high-risk person in the same household during the study period.

Locations (6)

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Chennai, India

GSK Investigational Site

Goa, India

GSK Investigational Site

Kolkata, India

Outcomes

Primary Outcomes

Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies

Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

Time frame: At 42 - 56 days after the second vaccination dose at week 30

Secondary Outcomes

Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies

Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

Time frame: Approximately 42 to 56 days after the first vaccine dose at week 6

Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses

Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).

Time frame: At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)

Data from ClinicalTrials.gov

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