Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

GlaxoSmithKline1 site in 1 country996 target enrollmentJuly 1, 2014

ConditionsRubella Mumps Measles

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rubella
Sponsor: GlaxoSmithKline
Enrollment: 996
Locations: 1
Primary Endpoint: Anti-measles Virus Antibody Concentrations.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.

Detailed Description

This study will evaluate the immunogenicity of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) in contrast to the US standard of care (M-M-R®II, Merck and Company, referred to as COM_MMR) when both are used as a second dose in subjects 7 years of age and older. In this study, the INV_MMR vaccine may be administered as a second dose to persons with either a history or formal documentation of at least one dose immunization with any MMR vaccine. This study is intended to support licensure of GSK's MMR vaccine in the US.

Registry

clinicaltrials.gov

Start Date

July 1, 2014

End Date

September 17, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
•Male or female subjects 7 years of age or older and born after December 31, 1956\*. \*The only exception to this is health care workers born before 1957 without other evidence of immunity to mumps for which one dose of a live mumps virus vaccine is recommended; therefore this population is eligible for enrollment in this study.
•For all children 7-17 years of age:
•Written documentation of prior receipt of 1 dose of MMR vaccine administered on or after the first birthday.
•For all adults 18 years of age and older:
•Prior receipt (written or verbal history) of at least one dose of MMR vaccine.
•Birth in the US.
•Written informed consent obtained from the subject or from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects who are still legally minors in line with local rules and regulations).
•Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
•Female subjects of non-childbearing potential may be enrolled in the study.

Exclusion Criteria

•Child in care.
•For all children 7-17 years of age:
•Previous receipt of more than 1 dose of a measles-containing vaccine.
•Use of any investigational or non-registered product other than the study vaccine(s), during the period starting 30 days preceding the day of study vaccination, (i.e. 30 days prior to Day 0) or planned use during the entire study period.
•Receipt of any measles, mumps or rubella-containing vaccine during the period starting 42 days before the day of study vaccination (i.e. 42 days prior to Day 0).
•Chronic administration (defined as 14 or more consecutive days) of immunosuppressants or other immune-modifying drugs during the period starting 180 days before study vaccination or any planned administration of immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination through the immunogenicity evaluation at Visit 2 or Visit 3 (for one-dose or two-dose cohort, respectively).
•Planned administration/ administration of any live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination and ending at Visit
•Live intranasal influenza vaccine or any inactivated vaccine required in the age group may be given at any time, including the day of study vaccination.
•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.

Outcomes

Primary Outcomes

Anti-measles Virus Antibody Concentrations.

Time Frame: At Day 42

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.

Anti-mumps Virus Antibody Concentrations

Time Frame: At Day 42

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL

Anti-rubella Virus Antibody Concentrations.

Time Frame: At Day 42

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL

Secondary Outcomes

Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).(At Day 42)
Number of Subjects With Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
Number of Subjects Reporting Fever(During the 43 days (Days 0-42) post-vaccination period.)
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)(At Day 42)
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.(During the 43 days (Days 0-42) post-vaccination period.)
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).(At Day 42)
Number of Subjects Reporting Adverse Events Prompting ER Visits(Day 0 through the end of the study (Day 180))
Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.(At Day 42)
Number of Subjects Reporting NOCDs(Day 0 through the end of the study (Day 180))
Number of Subjects Reporting Unsolicited AEs(During the 43 days (Days 0-42) post-vaccination period.)
Number of Subjects Reporting Solicited Rash Symptom(During the 43 days (Days 0-42) post-vaccination period.)
Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)(During the 43 days (Days 0-42) post-vaccination period.)
Number of Subjects Reporting Serious Adverse Events (SAEs)(Day 0 through the end of the study (Day 180))