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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02184572
Other study ID # 115650
Secondary ID 2011-006161-18
Status Completed
Phase Phase 3
First received
Last updated
Start date August 25, 2014
Est. completion date December 22, 2015

Study information

Verified date December 2020
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) at a potency that will be used to define maximum release limits for the INV_MMR in comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM_MMR vaccine). In order to obtain more representative data on the comparator vaccine, the COM_MMR used in this study will consist of two lots designated COM_MMR_L1 and COM_MMR_L2. Throughout the study COM_MMR_L1 and COM_MMR_L2 will be analyzed as pooled lots. This study is intended to support licensure of GSK's MMR vaccine in the US. All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to participants enrolled in selected non-US countries if local health departments do not routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and varicella vaccine is not part of the study procedures.


Recruitment information / eligibility

Status Completed
Enrollment 1742
Est. completion date December 22, 2015
Est. primary completion date August 14, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 15 Months
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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. - A family history of congenital or hereditary immunodeficiency. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin. - 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 =38.0°C/100.4°F 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 based on medical history. - Any other condition which, in the opinion of the investigator, prevents the child from participating in the study. - For US children only: a child that previously received a fourth dose of PCV-13 vaccine.

Study Design


Intervention

Biological:
Priorix
1 dose administered subcutaneously in the triceps region of left arm at Day 0
M-M-R II
1 dose administered subcutaneously in the triceps region of left arm at Day 0
Varivax
1 dose administered subcutaneously in the triceps region of right arm at Day 0
Havrix
1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0
Prevnar 13
1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US

Locations

Country Name City State
Estonia GSK Investigational Site Tartu
Finland GSK Investigational Site Espoo
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Jarvenpaa
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Turku
Puerto Rico GSK Investigational Site Guayama
Puerto Rico GSK Investigational Site Ponce
Puerto Rico GSK Investigational Site San Juan
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taipei
Taiwan GSK Investigational Site Taipei
Taiwan GSK Investigational Site Taoyuan
United States GSK Investigational Site Anaheim California
United States GSK Investigational Site Asheboro North Carolina
United States GSK Investigational Site Augusta Kansas
United States GSK Investigational Site Baldwin Park California
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Bardstown Kentucky
United States GSK Investigational Site Binghamton New York
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boone North Carolina
United States GSK Investigational Site Bossier City Louisiana
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charlottesville Virginia
United States GSK Investigational Site Cheraw South Carolina
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Clyde North Carolina
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Columbia Maryland
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site Daly City California
United States GSK Investigational Site Dayton Ohio
United States GSK Investigational Site Dayton Ohio
United States GSK Investigational Site Ellensburg Washington
United States GSK Investigational Site Erie Pennsylvania
United States GSK Investigational Site Fayetteville Arkansas
United States GSK Investigational Site Frederick Maryland
United States GSK Investigational Site Fresno California
United States GSK Investigational Site Hayward California
United States GSK Investigational Site Huntington West Virginia
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Kansas City Missouri
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Layton Utah
United States GSK Investigational Site League City Texas
United States GSK Investigational Site Lincoln Nebraska
United States GSK Investigational Site Lincoln Nebraska
United States GSK Investigational Site Lincoln Nebraska
United States GSK Investigational Site Mandan North Dakota
United States GSK Investigational Site Marshfield Wisconsin
United States GSK Investigational Site Metairie Louisiana
United States GSK Investigational Site Miami Lakes Florida
United States GSK Investigational Site Monroe Wisconsin
United States GSK Investigational Site Murray Utah
United States GSK Investigational Site Nampa Idaho
United States GSK Investigational Site Newton Kansas
United States GSK Investigational Site Niles Michigan
United States GSK Investigational Site Norwich Connecticut
United States GSK Investigational Site Oakland California
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Orem Utah
United States GSK Investigational Site Paramount California
United States GSK Investigational Site Payson Utah
United States GSK Investigational Site Pleasanton California
United States GSK Investigational Site Provo Utah
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Roseville California
United States GSK Investigational Site Roy Utah
United States GSK Investigational Site Sacramento California
United States GSK Investigational Site Sacramento California
United States GSK Investigational Site Saint George Utah
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site San Jose California
United States GSK Investigational Site Santa Clara California
United States GSK Investigational Site Sellersville Pennsylvania
United States GSK Investigational Site Sioux Falls South Dakota
United States GSK Investigational Site Sioux Falls South Dakota
United States GSK Investigational Site South Jordan Utah
United States GSK Investigational Site Spartanburg South Carolina
United States GSK Investigational Site Stevensville Michigan
United States GSK Investigational Site Syracuse New York
United States GSK Investigational Site Syracuse New York
United States GSK Investigational Site Syracuse Utah
United States GSK Investigational Site Tomball Texas
United States GSK Investigational Site Topeka Kansas
United States GSK Investigational Site Tucson Arizona
United States GSK Investigational Site Walnut Creek California
United States GSK Investigational Site Watertown South Dakota
United States GSK Investigational Site West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Estonia,  Finland,  Puerto Rico,  Taiwan, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage 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 greater than or equal to [=] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before vaccination. At Day 42 post vaccination
Secondary Anti-measles Virus Antibody Concentrations Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only. At Day 42 post vaccination
Secondary Percentage 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 Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration < 5 EU/mL) before vaccination. At Day 42 post vaccination
Secondary Anti-mumps Virus Antibody Concentrations Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only. At Day 42 post vaccination
Secondary Percentage 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 Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration < 4 IU/mL) before vaccination. At Day 42 post vaccination
Secondary Anti-rubella Virus Antibody Concentrations Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only. At Day 42 post vaccination
Secondary Number of Subjects With Any Solicited Local Adverse Events (AEs) Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. During the 4-day (Days 0-3) post-vaccination period
Secondary Number of Subjects With Any Solicited General AEs Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. During the 15-day (Days 0-14) post-vaccination period
Secondary Number of Subjects Reporting Any Fever Any fever (= 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination. During the 43-day (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting Any Rash Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination. During the 43-day (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting MMR Specific Solicited General AEs Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. During the 43-day (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting Any Unsolicited AEs Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. During the 43-day (Days 0-42) post-vaccination period
Secondary Number of Subjects Reporting AEs of Specific Interest AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits. Day 0 through the end of the study (Day 180)
Secondary Number of Subjects Reporting Any Serious Adverse Events (SAEs) SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination. Day 0 through the end of the study (Day 180)
Secondary Number of Subjects Reporting Measles-like Illness Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:
maculopapular rash (includes measles/rubella-like rash), fever (= 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.
During Day 5 to Day 12 post-vaccination period
See also
  Status Clinical Trial Phase
Completed NCT01681992 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life Phase 3
Completed NCT00861744 - Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age Phase 2