Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age

NCT02184572 | Completed Phase 3 Results

• 2 other identifiers: 1156502011-006161-18
• Study Type: interventional
• Target: 1,742
• Locations: 5 countries
• Sites: 95

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.

Conditions

Measles; Mumps; Rubella; Measles-Mumps-Rubella Vaccine

Keywords

Rubella; Healthy children; Measles; Safety; Mumps; 12 to 15 months; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination

  Fever was assessed for temperature equal to/above (≥) 38.0°C and above (\>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV\_MMR minus COM\_MMR) in incidence of fever equal to or below the cut-off value.

  During Day 5 to Day 12 post-vaccination period

Secondary Outcomes (15)

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

  At Day 42 post vaccination

• Anti-measles Virus Antibody Concentrations

  At Day 42 post vaccination

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

  At Day 42 post vaccination

• Anti-mumps Virus Antibody Concentrations

  At Day 42 post vaccination

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

  At Day 42 post vaccination

Study Arms (2)

INV_MMR

EXPERIMENTAL

Subjects receive 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.

Biological: Priorix; Biological: Varivax; Biological: Havrix; Biological: Prevnar 13

COM_MMR

ACTIVE COMPARATOR

Subjects receive 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.

Biological: M-M-R II; Biological: Varivax; Biological: Havrix; Biological: Prevnar 13

Interventions

Priorix BIOLOGICAL

1 dose administered subcutaneously in the triceps region of left arm at Day 0

Also known as: GSK Biologicals' live attenuated measles, mumps and rubella (MMR) vaccine

INV_MMR

M-M-R II BIOLOGICAL

1 dose administered subcutaneously in the triceps region of left arm at Day 0

Also known as: MMR vaccine live (M-M R II, Merck & Co., Inc., or M-M-R VaxPro, Sanofi Pasteur/Merck Sharp and Dohme [SPMSD])

COM_MMR

Varivax BIOLOGICAL

1 dose administered subcutaneously in the triceps region of right arm at Day 0

Also known as: Merck & Co. Inc.'s Varicella virus vaccine, live

COM_MMR; INV_MMR

Havrix BIOLOGICAL

1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0

Also known as: GSK Biologicals' Hepatitis A vaccine, inactivated

COM_MMR; INV_MMR

Prevnar 13 BIOLOGICAL

1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US

Also known as: Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)

COM_MMR; INV_MMR

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday until the day before age 16 months) at the time of vaccination.
• Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/LAR(s) of the child.
• Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history.
• For US children only: a child who received all routine vaccinations as per ACIP recommendations prior to study entry: completion of hepatitis B and rotavirus series and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant series of Prevnar 13 should be completed at least 60 days prior to study vaccination.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period.
• Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the study vaccination at Visit 1 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
• For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
• Inhaled and topical steroids are allowed.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the day of study vaccination at Visit 1 and ending at Visit 2. Please Note:
• Inactivated influenza (Flu) vaccine and monovalent Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
• Any other age appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
• Administration of immunoglobulins and/or any blood products during the period starting 180 days before the study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
• History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.
• Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination.
• Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (95)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Tucson, Arizona, 85741, United States

Location

GSK Investigational Site

Fayetteville, Arkansas, 72703, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, 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

Paramount, California, 90723, United States

Location

GSK Investigational Site

Pleasanton, California, 94588, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

Sacramento, California, 95815, United States

Location

GSK Investigational Site

Sacramento, California, 95823, United States

Location

GSK Investigational Site

San Jose, California, 95119, 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

Norwich, Connecticut, 06360, United States

Location

GSK Investigational Site

Miami Lakes, Florida, 33014, United States

Location

GSK Investigational Site

Nampa, Idaho, 83686, United States

Location

GSK Investigational Site

Augusta, Kansas, 67010, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Topeka, Kansas, 66604, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Bossier City, Louisiana, 71111, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21021, United States

Location

GSK Investigational Site

Columbia, Maryland, 21045, United States

Location

GSK Investigational Site

Frederick, Maryland, 21702, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02118, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02130, United States

Location

GSK Investigational Site

Niles, Michigan, 49120, United States

Location

GSK Investigational Site

Stevensville, Michigan, 49127, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64114, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68504, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68505, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68516, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68114, United States

Location

GSK Investigational Site

Binghamton, New York, 13901, United States

Location

GSK Investigational Site

Syracuse, New York, 13202, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Asheboro, North Carolina, 27203, United States

Location

GSK Investigational Site

Boone, North Carolina, 28607, United States

Location

GSK Investigational Site

Clyde, North Carolina, 28721, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Mandan, North Dakota, 58501, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

GSK Investigational Site

Columbus, Ohio, 43213, United States

Location

GSK Investigational Site

Dayton, Ohio, 45406, United States

Location

GSK Investigational Site

Dayton, Ohio, 45414, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16505, United States

Location

GSK Investigational Site

Sellersville, Pennsylvania, 18960, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406, United States

Location

GSK Investigational Site

Cheraw, South Carolina, 29520, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Sioux Falls, South Dakota, 57105, United States

Location

GSK Investigational Site

Sioux Falls, South Dakota, 57108, United States

Location

GSK Investigational Site

Watertown, South Dakota, 57201, United States

Location

GSK Investigational Site

Kingsport, Tennessee, 37660, United States

Location

GSK Investigational Site

League City, Texas, 77573, United States

Location

GSK Investigational Site

Tomball, Texas, 77375, United States

Location

GSK Investigational Site

Layton, Utah, 84041, United States

Location

GSK Investigational Site

Murray, Utah, 84124, United States

Location

GSK Investigational Site

Orem, Utah, 84057, United States

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GSK Investigational Site

Payson, Utah, 84651, United States

Location

GSK Investigational Site

Provo, Utah, 84604, United States

Location

GSK Investigational Site

Roy, Utah, 84067, 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

Syracuse, Utah, 84075, United States

Location

GSK Investigational Site

West Jordan, Utah, 84088, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22902, United States

Location

GSK Investigational Site

Ellensburg, Washington, 98926, United States

Location

GSK Investigational Site

Huntington, West Virginia, 25701, United States

Location

GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

Location

GSK Investigational Site

Monroe, Wisconsin, 53566, United States

Location

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Guayama, 00784, Puerto Rico

Location

GSK Investigational Site

Ponce, 00716, Puerto Rico

Location

GSK Investigational Site

San Juan, 00936-5067, Puerto Rico

Location

GSK Investigational Site

Taichung, 404, Taiwan

Location

GSK Investigational Site

Taichung, 407, 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-162 Study Group. Safety and immunogenicity of an upper-range release titer measles-mumps-rubella vaccine in children vaccinated at 12 to 15 months of age: a phase III, randomized study. Hum Vaccin Immunother. 2018;14(12):2921-2931. doi: 10.1080/21645515.2018.1502527. Epub 2018 Aug 29.

  PMID: 30118386 BACKGROUND

MeSH Terms

Conditions

Measles; Mumps; Rubella

Interventions

Measles-Mumps-Rubella Vaccine; Vaccines; Chickenpox Vaccine; Hepatitis A Vaccines; 13-valent pneumococcal vaccine; CRM197 (non-toxic variant of diphtheria toxin)

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; Rubivirus Infections; Togaviridae Infections

Intervention Hierarchy (Ancestors)

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

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: July 3, 2014
• First Posted: July 9, 2014
• Study Start: August 25, 2014
• Primary Completion: August 14, 2015
• Study Completion: December 22, 2015
• Last Updated: January 7, 2021
• Results First Posted: July 3, 2018

Record last verified: 2020-12

Locations

US (80); ES (1); PR (3); FI (6); TW (5)