Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age

GlaxoSmithKline1,851 enrolled

Overview

The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,851

Conditions

Varicella Rubella Mumps Measles

Interventions

Priorix-Tetra™ (MMRV vaccine 208136)BIOLOGICAL

One subcutaneous injection.

ProQuad®BIOLOGICAL

One subcutaneous injection.

Havrix®BIOLOGICAL

Two intramuscular injections.

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 14 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol. * Male or female between 12 and 14 months of age at the time of first vaccination. * Written informed consent obtained from the parent/guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life. Exclusion Criteria: * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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-investigational product. * 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 from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine. * Previous vaccination against measles, mumps, rubella and/or varicella. * Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine. * History of measles, mumps, rubella and/or varicella/zoster diseases. * Known exposure to measles, mumps, rubella and/or varicella/zoster 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, including human immunodeficiency virus infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion. * Residence in the same household as the following persons: * New-born infants (0-4 weeks of age). * Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox. * Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history. * Persons with known immunodeficiency. * Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness. * Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).

Locations (141)

Outcomes

Primary Outcomes

Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)

Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.

Time frame: At Day 42 after vaccination

Concentration of Antibodies to Varicella Virus (VZV)

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time frame: At Day 42 after vaccination

Number of Subjects With Seroresponse for Antibodies to Mumps Virus

Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies \[titer greater than or equal to the threshold of 51 Effective Doses (ED50)\] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.

Time frame: At Day 42 after vaccination

Number of Subjects With Seroresponse for Antibodies to Measles Virus

Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies \[concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.

Time frame: At Day 42 after vaccination

Number of Subjects With Seroresponse for Antibodies to Rubella Virus

Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies \[concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)\] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.

Time frame: At Day 42 after vaccination

Data from ClinicalTrials.gov

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GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Benton, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Buena Park, California, United States

...and 131 more locations

Secondary Outcomes

Antibody Titers to Mumps Virus

Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.

Time frame: At Day 42 after vaccination

Concentration of Antibodies to Measles Virus

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time frame: At Day 42 after vaccination

Concentration of Antibodies to Rubella Virus

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time frame: At Day 42 after vaccination

Number of Subjects With Vaccine Response to Havrix

Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies \[concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)\] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.

Time frame: At Day 42 after vaccination

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).

Time frame: At Day 42 after vaccination

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).

Time frame: At Day 42 after vaccination

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).

Time frame: At Day 42 after vaccination

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).

Time frame: At Day 42 after vaccination

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Time frame: During the 4 day follow up period following vaccination

Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination

Fever was measured rectally.

Time frame: During the 15-day follow-up period following vaccination

Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination

Fever was measured rectally.

Time frame: During the 43-day follow-up period following vaccination

Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash

Time frame: During the 43-day follow-up period after vaccination

Number of Subjects Reporting Investigator-confirmed Varicella-like Rash

Time frame: During the 43-day follow-up period after vaccination

Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling

Time frame: During the 43-day follow-up period after vaccination

Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)

Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.

Time frame: During the 43-day follow-up period after vaccination

Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits

New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.

Time frame: For approximately 6 months (Day 0-180)

Number of Subjects Reporting Serious Adverse Events

Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Time frame: For approximately 6 months (Day 0-180)