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

NCT02058563 | Completed Phase 3 Results

• 2 other identifiers: 1152312011-003672-36
• Study Type: interventional
• Target: 996
• Locations: 3 countries
• Sites: 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.

Conditions

Rubella; Mumps; Measles

Keywords

Measles, mumps and rubella diseases; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (3)

• Anti-measles Virus Antibody Concentrations.

  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.

  At Day 42

• Anti-mumps Virus Antibody Concentrations

  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

  At Day 42

• Anti-rubella Virus Antibody Concentrations.

  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

  At Day 42

Secondary Outcomes (13)

• 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 With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).

  At Day 42

• 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 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 With Solicited Local Symptoms

  During the 4-day (Days 0-3) post-vaccination period

Study Arms (2)

INV_MMR Group

EXPERIMENTAL

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

Biological: Priorix®

COM_MMR Group

ACTIVE COMPARATOR

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

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

Interventions

Priorix® BIOLOGICAL

1 dose administered as a subcutaneous (SC) injection.

INV_MMR Group

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

1 dose administered subcutaneously.

COM_MMR Group

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Parexel: collaborator

Study Sites (17)

GSK Investigational Site

Birmingham, Alabama, 35211, United States

Location

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Mesa, Arizona, United States

Location

GSK Investigational Site

Miami, Florida, 33144, United States

Location

GSK Investigational Site

Miami, Florida, 33176, United States

Location

GSK Investigational Site

Chicago, Illinois, 60654, United States

Location

GSK Investigational Site

Edina, Minnesota, 55435, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45249, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Bratislava, 851 01, Slovakia

Location

GSK Investigational Site

Dolný Kubín, 026 01, Slovakia

Location

GSK Investigational Site

Dunajská Streda, 929 01, Slovakia

Location

GSK Investigational Site

Martin, 036 01, Slovakia

Location

GSK Investigational Site

Ružomberok, 034 01, Slovakia

Location

GSK Investigational Site

Zlaté Moravce, 953 01, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 29902133 DERIVED

MeSH Terms

Conditions

Rubella; Mumps; Measles

Interventions

Measles-Mumps-Rubella Vaccine; Rubella Vaccine

Condition Hierarchy (Ancestors)

Rubivirus Infections; Togaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Morbillivirus Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: July 1, 2014
• Primary Completion: May 24, 2015
• Study Completion: September 17, 2015
• Last Updated: June 6, 2018
• Results First Posted: April 10, 2017

Record last verified: 2018-05

Locations

ES (1); SL (6); US (10)