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Trial record 3 of 55 for:    priorix | Measles

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02058563
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : April 10, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Rubella
Mumps
Measles
Interventions Biological: Priorix®
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
Enrollment 996
Recruitment Details A total of 996 subjects were enrolled and 994 were vaccinated. Of the 994 vaccinated subjects, 83 subjects from 2 US sites were excluded due to significant GCP concerns, resulting in 911 subjects in the Total vaccinated cohort considered for the analysis.
Pre-assignment Details  
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0). Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Period Title: Overall Study
Started 454 457
Completed 426 433
Not Completed 28 24
Reason Not Completed
Lost to Follow-up             26             22
Other (vaccinated later as new subject)             1             0
Consent Withdrawal             1             1
Other (patient incarcerated)             0             1
Arm/Group Title INV_MMR Group COM_MMR Group Total
Hide Arm/Group Description Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0). Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). Total of all reporting groups
Overall Number of Baseline Participants 454 457 911
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 454 participants 457 participants 911 participants
25.9  (13.9) 25.6  (13.8) 25.7  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 454 participants 457 participants 911 participants
Female
250
  55.1%
252
  55.1%
502
  55.1%
Male
204
  44.9%
205
  44.9%
409
  44.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 454 participants 457 participants 911 participants
African Heritage/African American 108 103 211
American Indian or Alaskan native 2 4 6
Asian - Central/South Asian heritage 1 0 1
Asian - East Asian heritage 1 0 1
Asian - Japanese heritage 0 1 1
Asian - South East Asian heritage 0 0 0
Native Hawaiian or other Pacific Islander 1 0 1
White - Arabic/North African heritage 0 1 1
White - Caucasian/European heritage 334 344 678
Other 7 4 11
1.Primary Outcome
Title Anti-measles Virus Antibody Concentrations.
Hide Description 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.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 433 436
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1795.6
(1641.1 to 1964.7)
1783.3
(1624.6 to 1957.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed
Type of Statistical Test Non-Inferiority or Equivalence
Comments Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.91 to 1.11
Estimation Comments Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively
2.Primary Outcome
Title Anti-mumps Virus Antibody Concentrations
Hide Description 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
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 433 436
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
110.6
(102.1 to 119.8)
110.2
(101.9 to 119.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.96 to 1.16
Estimation Comments Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.
3.Primary Outcome
Title Anti-rubella Virus Antibody Concentrations.
Hide Description 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
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 433 436
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
75.3
(70.3 to 80.6)
75.6
(70.8 to 80.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed
Type of Statistical Test Non-Inferiority or Equivalence
Comments Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.93 to 1.11
Estimation Comments Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.
4.Secondary Outcome
Title Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)
Hide Description

Seroresponse was defined as:

Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 433 436
Measure Type: Number
Unit of Measure: Subjects
428 432
5.Secondary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).
Hide Description

Seroresponse was defined as:

Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 433 436
Measure Type: Number
Unit of Measure: Subjects
426 434
6.Secondary Outcome
Title Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).
Hide Description

Seroresponse was defined as:

Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 433 436
Measure Type: Number
Unit of Measure: Subjects
431 435
7.Secondary Outcome
Title Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.
Hide Description For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 432 435
Measure Type: Number
Unit of Measure: Subjects
Anti-measles 42 48
Anti-mumps 152 128
Anti-rubella 179 161
8.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter >50mm. Grade 3 swelling = swelling with surface diameter >50mm.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 433 445
Measure Type: Number
Unit of Measure: Subjects
Any injection site redness 53 52
Grade 3 injection site redness 0 0
Any injection site swelling 23 29
Grade 3 injection site swelling 0 0
Any injection site pain 51 51
Grade 3 injection site pain 1 0
9.Secondary Outcome
Title Number of Subjects Reporting Fever
Hide Description Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever >39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.
Time Frame During the 43 days (Days 0-42) post-vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 431 445
Measure Type: Number
Unit of Measure: Subjects
Any 13 23
Grade 3 1 6
Related 2 6
10.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.
Hide Description Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.
Time Frame During the 43 days (Days 0-42) post-vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 431 445
Measure Type: Number
Unit of Measure: Subjects
Any parotid/salivary gland swelling 1 1
Grade 3 parotid/salivary gland swelling 1 0
Related parotid/salivary gland swelling 0 0
Any meningism/seizure 1 1
Grade 3 meningism/seizure 1 0
Related meningism/seizure 0 0
11.Secondary Outcome
Title Number of Subjects Reporting Unsolicited AEs
Hide Description Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time Frame During the 43 days (Days 0-42) post-vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 454 457
Measure Type: Number
Unit of Measure: Subjects
95 82
12.Secondary Outcome
Title Number of Subjects Reporting Solicited Rash Symptom
Hide Description Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.
Time Frame During the 43 days (Days 0-42) post-vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 431 445
Measure Type: Number
Unit of Measure: Subjects
Any 9 5
Grade 3 0 0
Related 6 2
Localized rash 8 3
Generalized rash 1 2
Rash type - measles/rubella-rash 0 2
Rash type - others 9 3
13.Secondary Outcome
Title Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)
Hide Description Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.
Time Frame During the 43 days (Days 0-42) post-vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 431 445
Measure Type: Number
Unit of Measure: subjects
Any 8 4
Grade 3 0 0
Related 3 1
14.Secondary Outcome
Title Number of Subjects Reporting NOCDs
Hide Description Occurrence of new onset chronic diseases (NOCDs)
Time Frame Day 0 through the end of the study (Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 454 457
Measure Type: Number
Unit of Measure: Subjects
2 1
15.Secondary Outcome
Title Number of Subjects Reporting Adverse Events Prompting ER Visits
Hide Description Occurrence of AEs prompting emergency room (ER) visits.
Time Frame Day 0 through the end of the study (Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 454 457
Measure Type: Number
Unit of Measure: Subjects
14 9
16.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
Time Frame Day 0 through the end of the study (Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 454 457
Measure Type: Number
Unit of Measure: Subjects
3 7
Time Frame Serious Adverse Events: From Day 0 to Day 180, Solicited Local Adverse Events: From Day 0 to Day 3, Solicited General and Unsolicited Adverse Events: From Day 0 to Day 42
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0). Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
All-Cause Mortality
INV_MMR Group COM_MMR Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
INV_MMR Group COM_MMR Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/454 (0.66%)      7/457 (1.53%)    
Gastrointestinal disorders     
Abdominal pain * 1  0/454 (0.00%)  0 1/457 (0.22%)  1
Abdominal pain lower * 1  1/454 (0.22%)  1 0/457 (0.00%)  0
Pancreatitis relapsing * 1  0/454 (0.00%)  0 1/457 (0.22%)  1
Hepatobiliary disorders     
Biliary colic * 1  1/454 (0.22%)  1 0/457 (0.00%)  0
Infections and infestations     
Pyelonephritis * 1  0/454 (0.00%)  0 1/457 (0.22%)  1
Injury, poisoning and procedural complications     
Jaw fracture * 1  0/454 (0.00%)  0 1/457 (0.22%)  1
Tendon injury * 1  1/454 (0.22%)  1 0/457 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  0/454 (0.00%)  0 1/457 (0.22%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  0/454 (0.00%)  0 2/457 (0.44%)  2
Psychiatric disorders     
Psychogenic seizure * 1  1/454 (0.22%)  1 0/457 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
INV_MMR Group COM_MMR Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   93/454 (20.48%)      102/457 (22.32%)    
General disorders     
Injection site erythema  53/454 (11.67%)  53 52/457 (11.38%)  52
Injection site swelling  23/454 (5.07%)  23 29/457 (6.35%)  29
Pyrexia  13/454 (2.86%)  13 23/457 (5.03%)  23
Vaccination site pain  51/454 (11.23%)  51 51/457 (11.16%)  51
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02058563    
Other Study ID Numbers: 115231
2011-003672-36 ( EudraCT Number )
First Submitted: February 6, 2014
First Posted: February 10, 2014
Results First Submitted: December 30, 2016
Results First Posted: April 10, 2017
Last Update Posted: June 6, 2018