Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older

NCT ID: NCT02058563

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 996 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2015-09-17

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.

Conditions

Rubella; Mumps; Measles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

INV_MMR Group

Subjects will receive 1 dose of GSK Biologicals' trivalent Measles, Mumps, and Rubella Virus Vaccine (Priorix®).

Group Type: EXPERIMENTAL

Priorix®

Intervention Type: BIOLOGICAL

1 dose administered as a subcutaneous (SC) injection.

COM_MMR Group

Subjects will receive 1 dose of Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine.

Group Type: ACTIVE_COMPARATOR

Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine

Intervention Type: BIOLOGICAL

1 dose administered subcutaneously.

Interventions

Priorix®

1 dose administered as a subcutaneous (SC) injection.

Intervention Type: BIOLOGICAL

Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine

1 dose administered subcutaneously.

Intervention Type: BIOLOGICAL

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.

• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, or ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject

• Has agreed to be abstinent or practiced adequate contraception during the entire period starting 30 days prior to vaccination(s) until 3 months after receipt of the study vaccination and
• has a negative pregnancy test on the day of vaccination.

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 2. 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.
• History of measles, mumps, or rubella disease.
• Known exposure to measles, mumps, or rubella, during the period starting 30 days before study start (i.e. 30 days prior to Day 0).
• %

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Edina, Minnesota, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Dolný Kubín, , Slovakia

GSK Investigational Site

Dunajská Streda, , Slovakia

GSK Investigational Site

Martin, , Slovakia

GSK Investigational Site

Ružomberok, , Slovakia

GSK Investigational Site

Zlaté Moravce, , Slovakia

Countries

United States; Estonia; Slovakia

References

Abu-Elyazeed R, Jennings W, Severance R, Noss M, Caplanusi A, Povey M, Henry O. Immunogenicity and safety of a second dose of a measles-mumps-rubella vaccine administered to healthy participants 7 years of age or older: A phase III, randomized study. Hum Vaccin Immunother. 2018;14(11):2624-2631. doi: 10.1080/21645515.2018.1489186. Epub 2018 Jul 12.

Reference Type: DERIVED

PMID: 29902133 (View on PubMed)

Other Identifiers

2011-003672-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

115231

Identifier Type: -

Identifier Source: org_study_id