Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

NCT01621802 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 1151582011-004638-32
• Study Type: interventional
• Target: 4,011
• Locations: 3 countries
• Sites: 67

Brief Summary

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

Conditions

Measles-Mumps-Rubella

Keywords

Safety; Measles, mumps and rubella diseases; Immunogenicity

Outcome Measures

Primary Outcomes (6)

• Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value

  Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.

  42 days post vaccination (At Day 42)

• Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value

  Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.

  42 days post vaccination (At Day 42)

• Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value

  Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.

  42 days post vaccination (At Day 42)

• Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations

  Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.

  42 days after vaccination (At Day 42)

• Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations

  Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.

  42 days post vaccination (At Day 42)

• Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations

  Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.

  42 days post vaccination (At Day 42)

Secondary Outcomes (20)

• Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value

  42 days post vaccination (At Day 42)

• Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations

  42 days post vaccination (At Day 42)

• Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)

  42 days post vaccination (At Day 42)

• Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)

  42 days post vaccination (At Day 42)

• Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)

  42 days post vaccination (At Day 42)

Study Arms (6)

Inv _MMR_CO Group

EXPERIMENTAL

Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).

Biological: Priorix; Biological: Kinrix; Biological: ProQuad

Com_MMR_CO Group

ACTIVE COMPARATOR

Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).

Biological: M-M-R II; Biological: Kinrix; Biological: ProQuad

Inv_MMR_I Group

EXPERIMENTAL

Subjects received one dose of Priorix at Visit 1 (Day 0).

Biological: Priorix

Com_MMR_I Group

ACTIVE COMPARATOR

Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

Biological: M-M-R II

Inv _MMR_S Group

EXPERIMENTAL

Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).

Biological: Priorix

Com_MMR_S Group

ACTIVE COMPARATOR

Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

Biological: M-M-R II

Interventions

Priorix BIOLOGICAL

One dose administered subcutaneously in the triceps region of the right arm.

Inv _MMR_CO Group; Inv _MMR_S Group; Inv_MMR_I Group

M-M-R II BIOLOGICAL

One dose administered subcutaneously in the triceps region of the right arm.

Com_MMR_CO Group; Com_MMR_I Group; Com_MMR_S Group

Kinrix BIOLOGICAL

One dose administered by deep intramuscular injection in the upper left deltoid.

Com_MMR_CO Group; Inv _MMR_CO Group

ProQuad BIOLOGICAL

One dose administered subcutaneously in the triceps region of the left arm.

Com_MMR_CO Group; Inv _MMR_CO Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
• Male or female subjects 4 to 6 years of age at the time of vaccination.
• Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
• Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
• Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
• For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:
• subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
• subjects received a first dose of VV in the second year of life.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
• Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and 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 before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
• 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, and/or rubella disease.
• Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin or gelatin.
• Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
• Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
• Active untreated tuberculosis according to the subject's medical history.
• Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (67)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Tucson, Arizona, 85704, United States

Location

GSK Investigational Site

Tucson, Arizona, 85741, United States

Location

GSK Investigational Site

Benton, Arkansas, 72019, United States

Location

GSK Investigational Site

Fayetteville, Arkansas, 72703, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Anaheim, California, 92804, United States

Location

GSK Investigational Site

Baldwin Park, California, 91706, United States

Location

GSK Investigational Site

Daly City, California, 94015, United States

Location

GSK Investigational Site

Fresno, California, 93726, United States

Location

GSK Investigational Site

Hayward, California, 94545, United States

Location

GSK Investigational Site

Oakland, California, 94611, United States

Location

GSK Investigational Site

Pleasanton, California, 94588, United States

Location

GSK Investigational Site

Sacramento, California, 95815, United States

Location

GSK Investigational Site

Sacramento, California, 95823, United States

Location

GSK Investigational Site

Santa Clara, California, 95051, United States

Location

GSK Investigational Site

Walnut Creek, California, 94596, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80922, United States

Location

GSK Investigational Site

Altamonte Springs, Florida, 32701, United States

Location

GSK Investigational Site

Marietta, Georgia, 30062, United States

Location

GSK Investigational Site

Woodstock, Georgia, 30189, United States

Location

GSK Investigational Site

Nampa, Idaho, 83686, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46256, United States

Location

GSK Investigational Site

Augusta, Kansas, 67010, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Columbia, Maryland, 21045, United States

Location

GSK Investigational Site

Fall River, Massachusetts, 02721, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Asheboro, North Carolina, 27203, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45245, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

GSK Investigational Site

Dayton, Ohio, 45406, United States

Location

GSK Investigational Site

Dayton, Ohio, 45414, United States

Location

GSK Investigational Site

Gresham, Oregon, 97030, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16505, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29414, United States

Location

GSK Investigational Site

Cheraw, South Carolina, 29520, United States

Location

GSK Investigational Site

Rapid City, South Dakota, 57701, United States

Location

GSK Investigational Site

Houston, Texas, 77055, United States

Location

GSK Investigational Site

Tomball, Texas, 77375, United States

Location

GSK Investigational Site

Provo, Utah, 84604, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84109, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

St. George, Utah, 84790, United States

Location

GSK Investigational Site

Burke, Virginia, 22015, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22902, United States

Location

GSK Investigational Site

Huntington, West Virginia, 25701, United States

Location

GSK Investigational Site

Monroe, Wisconsin, 53566, United States

Location

GSK Investigational Site

Ansan, 425-707, South Korea

Location

GSK Investigational Site

Daegu, 700-712, South Korea

Location

GSK Investigational Site

Daejeon, 301-723, South Korea

Location

GSK Investigational Site

Gyeonggi-do, 431-070, South Korea

Location

GSK Investigational Site

GyeongSangNam-do, 641-560, South Korea

Location

GSK Investigational Site

Iksan, 570-711, South Korea

Location

GSK Investigational Site

Jeollabukdo, 561712, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 130-702, South Korea

Location

GSK Investigational Site

Seoul, 139-706, South Korea

Location

GSK Investigational Site

Seoul, 158-710, South Korea

Location

GSK Investigational Site

Wonju-si Kangwon-do, 220-701, South Korea

Location

GSK Investigational Site

New Taipei City, 220, Taiwan

Location

GSK Investigational Site

Taichung, 404, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 104, Taiwan

Location

GSK Investigational Site

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• MMR-158 Study Group. A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration. Hum Vaccin Immunother. 2019;15(4):786-799. doi: 10.1080/21645515.2018.1554971. Epub 2019 Feb 20.

  PMID: 30785357 BACKGROUND

MeSH Terms

Conditions

Measles; Mumps

Interventions

Measles-Mumps-Rubella Vaccine; DTPP vaccine; measles, mumps, rubella, varicella vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  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: June 14, 2012
• First Posted: June 18, 2012
• Study Start: June 21, 2012
• Primary Completion: July 6, 2015
• Study Completion: November 9, 2015
• Last Updated: November 25, 2019
• Results First Posted: September 13, 2017

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (50); KR (12); TW (5)