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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,742
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.
Time frame: During Day 5 to Day 12 post-vaccination period
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.
Time frame: At Day 42 post vaccination
Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
Time frame: At Day 42 post vaccination
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.
Time frame: At Day 42 post vaccination
Anti-mumps Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.
Time frame: At Day 42 post vaccination
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1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0
1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Baldwin Park, California, United States
GSK Investigational Site
Daly City, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Hayward, California, United States
GSK Investigational Site
Oakland, California, United States
...and 85 more locations
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.
Time frame: At Day 42 post vaccination
Anti-rubella Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.
Time frame: At Day 42 post vaccination
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period
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.
Time frame: During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting Any Fever
Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Rash
Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
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.
Time frame: During the 43-day (Days 0-42) post-vaccination period
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.
Time frame: During the 43-day (Days 0-42) post-vaccination period
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.
Time frame: Day 0 through the end of the study (Day 180)
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.
Time frame: Day 0 through the end of the study (Day 180)
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.
Time frame: During Day 5 to Day 12 post-vaccination period