Immunogenicity and Safety Study of GlaxoSmithKline (GSK)... | NCT01621802 | Trialant
NCT01621802
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Nov 25, 2019Actual
Enrollment
4,011Actual
Phase
Phase 3
Conditions
Measles-Mumps-Rubella
Interventions
Priorix
M-M-R II
Kinrix
ProQuad
Countries
United States
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT01621802
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
115158
Secondary IDs
ID
Type
Description
Link
2011-004638-32
EudraCT Number
Brief Title
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
Official Title
Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 21, 2012Actual
Primary Completion Date
Jul 6, 2015Actual
Completion Date
Nov 9, 2015Actual
First Submitted Date
Jun 14, 2012
First Submission Date that Met QC Criteria
Jun 14, 2012
First Posted Date
Jun 18, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 18, 2016
Results First Submitted that Met QC Criteria
Aug 14, 2017
Results First Posted Date
Sep 13, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 6, 2016
Certification/Extension First Submitted that Passed QC Review
Jul 6, 2016
Certification/Extension First Posted Date
Aug 2, 2016Estimated
Last Update Submitted Date
Nov 14, 2019
Last Update Posted Date
Nov 25, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.
The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.
Conditions Module
Conditions
Measles-Mumps-Rubella
Keywords
Safety
Measles, mumps and rubella diseases
Immunogenicity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
4,011Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
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
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:
Previous vaccination with a second dose of varicella-containing vaccine.
Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.
History of varicella/zoster disease.
Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.
History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.
Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.
Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.
Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
4 Years
Maximum Age
6 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
4011 subjects were enrolled in the study with 4007 eligible subjects receiving a study vaccination.
Recruitment Details
Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv_MMR_CO and Com_MMR_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv_MMR_I and Com_MMR_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv_MMR_S and Com_MMR_S (Lot 1 or Lot 2).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
FG001
Com_MMR_CO Group
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).
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
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
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)
Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
Booster response was defined as:
For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.
For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Pertactin (PRN)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.
42 days post vaccination (At Day 42)
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.
Analysis was done for sub-cohort 1 only.
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Fever
Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.
During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting MMR Specific Solicited General Symptoms
Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. 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. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.
During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Investigator-confirmed Rash
Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.
During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
During the entire study period (from Day 0 up to Day 180)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.
During the entire study period (from Day 0 up to Day 180)
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
During the entire study period (from Day 0 up to Day 180)
Tucson
Arizona
85704
United States
GSK Investigational Site
Tucson
Arizona
85741
United States
GSK Investigational Site
Benton
Arkansas
72019
United States
GSK Investigational Site
Fayetteville
Arkansas
72703
United States
GSK Investigational Site
Little Rock
Arkansas
72205
United States
GSK Investigational Site
Anaheim
California
92804
United States
GSK Investigational Site
Baldwin Park
California
91706
United States
GSK Investigational Site
Daly City
California
94015
United States
GSK Investigational Site
Fresno
California
93726
United States
GSK Investigational Site
Hayward
California
94545
United States
GSK Investigational Site
Oakland
California
94611
United States
GSK Investigational Site
Pleasanton
California
94588
United States
GSK Investigational Site
Sacramento
California
95815
United States
GSK Investigational Site
Sacramento
California
95823
United States
GSK Investigational Site
Santa Clara
California
95051
United States
GSK Investigational Site
Walnut Creek
California
94596
United States
GSK Investigational Site
Colorado Springs
Colorado
80922
United States
GSK Investigational Site
Altamonte Springs
Florida
32701
United States
GSK Investigational Site
Marietta
Georgia
30062
United States
GSK Investigational Site
Woodstock
Georgia
30189
United States
GSK Investigational Site
Nampa
Idaho
83686
United States
GSK Investigational Site
Indianapolis
Indiana
46256
United States
GSK Investigational Site
Augusta
Kansas
67010
United States
GSK Investigational Site
Newton
Kansas
67114
United States
GSK Investigational Site
Bardstown
Kentucky
40004
United States
GSK Investigational Site
Columbia
Maryland
21045
United States
GSK Investigational Site
Fall River
Massachusetts
02721
United States
GSK Investigational Site
The Bronx
New York
10467
United States
GSK Investigational Site
Asheboro
North Carolina
27203
United States
GSK Investigational Site
Raleigh
North Carolina
27609
United States
GSK Investigational Site
Cincinnati
Ohio
45245
United States
GSK Investigational Site
Cleveland
Ohio
44121
United States
GSK Investigational Site
Dayton
Ohio
45406
United States
GSK Investigational Site
Dayton
Ohio
45414
United States
GSK Investigational Site
Gresham
Oregon
97030
United States
GSK Investigational Site
Erie
Pennsylvania
16505
United States
GSK Investigational Site
Charleston
South Carolina
29414
United States
GSK Investigational Site
Cheraw
South Carolina
29520
United States
GSK Investigational Site
Rapid City
South Dakota
57701
United States
GSK Investigational Site
Houston
Texas
77055
United States
GSK Investigational Site
Tomball
Texas
77375
United States
GSK Investigational Site
Provo
Utah
84604
United States
GSK Investigational Site
Salt Lake City
Utah
84109
United States
GSK Investigational Site
South Jordan
Utah
84095
United States
GSK Investigational Site
St. George
Utah
84790
United States
GSK Investigational Site
Burke
Virginia
22015
United States
GSK Investigational Site
Charlottesville
Virginia
22902
United States
GSK Investigational Site
Huntington
West Virginia
25701
United States
GSK Investigational Site
Monroe
Wisconsin
53566
United States
GSK Investigational Site
Ansan
425-707
South Korea
GSK Investigational Site
Daegu
700-712
South Korea
GSK Investigational Site
Daejeon
301-723
South Korea
GSK Investigational Site
Gyeonggi-do
431-070
South Korea
GSK Investigational Site
GyeongSangNam-do
641-560
South Korea
GSK Investigational Site
Iksan
570-711
South Korea
GSK Investigational Site
Jeollabukdo
561712
South Korea
GSK Investigational Site
Seoul
120-752
South Korea
GSK Investigational Site
Seoul
130-702
South Korea
GSK Investigational Site
Seoul
139-706
South Korea
GSK Investigational Site
Seoul
158-710
South Korea
GSK Investigational Site
Wonju-si Kangwon-do
220-701
South Korea
GSK Investigational Site
New Taipei City
220
Taiwan
GSK Investigational Site
Taichung
404
Taiwan
GSK Investigational Site
Taipei
100
Taiwan
GSK Investigational Site
Taipei
104
Taiwan
GSK Investigational Site
Taoyuan
333
Taiwan
FG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
FG003
Com_MMR_I Group
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).
FG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
FG005
Com_MMR_S Group
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).
FG000802 subjects
FG001298 subjects
FG002796 subjects
FG003303 subjects
FG0041319 subjects
FG005489 subjects
COMPLETED
FG000755 subjects
FG001275 subjects
FG002763 subjects
FG003292 subjects
FG0041284 subjects
FG005477 subjects
NOT COMPLETED
FG00047 subjects
FG00123 subjects
FG00233 subjects
FG00311 subjects
FG00435 subjects
FG00512 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Withdrawal by Subject
FG0008 subjects
FG0014 subjects
FG0024 subjects
FG0032 subjects
FG004
Migrated/moved from study area
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Others
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG00036 subjects
FG00116 subjects
FG00224 subjects
FG0037 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
BG001
Com_MMR_CO Group
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).
BG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
BG003
Com_MMR_I Group
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).
BG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
BG005
Com_MMR_S Group
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).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000802
BG001298
BG002796
BG003303
BG0041319
BG005489
BG0064007
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG0004.1± 0.3
BG0014.1± 0.3
BG0024.4± 0.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000398
BG001134
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race/Ethnicity
Title
Measurements
African Heritage / African American
BG00096
BG00139
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
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).
Units
Counts
Participants
OG000697
OG001249
OG002736
OG003
Title
Denominators
Categories
Title
Measurements
OG000697
OG001249
OG002736
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.
The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.
Difference in seroresponse rate (%)
0.00
2-Sided
97.5
-0.72
1.98
Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.
Primary
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.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Primary
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.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Primary
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.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
mIU/mL
42 days after vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
Primary
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.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
Primary
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.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
Secondary
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Counts
Participants
Secondary
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
mIU/mL
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Counts
Participants
Secondary
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
Booster response was defined as:
For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.
For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Secondary
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Secondary
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Secondary
Number of Subjects With Antibody Booster Response to Pertactin (PRN)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Secondary
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Counts
Participants
Secondary
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Counts
Participants
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Counts
Participants
OG000
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Count of Participants
Participants
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Counts
Participants
OG000
Secondary
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
ED50
42 days post vaccination (At Day 42)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Counts
Participants
Secondary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Posted
Count of Participants
Participants
During the 4-day (Days 0-3) post-vaccination period
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.
Analysis was done for sub-cohort 1 only.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Posted
Count of Participants
Participants
During the 4-day (Days 0-3) post-vaccination period
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Units
Secondary
Number of Subjects Reporting Fever
Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Posted
Count of Participants
Participants
During the 43-day (Days 0-42) post-vaccination period
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
Secondary
Number of Subjects Reporting MMR Specific Solicited General Symptoms
Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. 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. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Posted
Count of Participants
Participants
During the 43-day (Days 0-42) post-vaccination period
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
Secondary
Number of Subjects Reporting Investigator-confirmed Rash
Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Posted
Count of Participants
Participants
During the 43-day (Days 0-42) post-vaccination period
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Secondary
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Count of Participants
Participants
During the entire study period (from Day 0 up to Day 180)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
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).
Secondary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Count of Participants
Participants
During the entire study period (from Day 0 up to Day 180)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
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).
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Count of Participants
Participants
During the 43-day (Days 0-42) post-vaccination period
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
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).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Count of Participants
Participants
During the entire study period (from Day 0 up to Day 180)
ID
Title
Description
OG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG001
Com_MMR_CO Group
Subjects received one dose of the licensed vaccine M-M-RII (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Time Frame
Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Inv_MMR_CO Group
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
0
802
4
802
544
802
EG001
Com_MMR_CO Group
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).
0
298
0
298
198
298
EG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
0
796
14
796
410
796
EG003
Com_MMR_I Group
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).
0
303
1
303
156
303
EG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
0
1,319
25
1,319
702
1,319
EG005
Com_MMR_S Group
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).
0
489
9
489
279
489
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG0030 events0 affected303 at risk
EG0040 events0 affected1,319 at risk
EG0051 events1 affected489 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Cyclic vomiting syndrome
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0023 events2 affected796 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Herpangina
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0022 events2 affected796 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Accidental exposure to product
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected802 at risk
EG0010 events0 affected298 at risk
EG0024 events4 affected796 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Status asthmaticus
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Eczema vesicular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected802 at risk
EG0010 events0 affected298 at risk
EG0020 events0 affected796 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00041 events38 affected802 at risk
EG00117 events16 affected298 at risk
EG00241 events37 affected796 at risk
EG0038 events8 affected303 at risk
EG00450 events47 affected1,319 at risk
EG00522 events21 affected489 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG000159 events156 affected802 at risk
EG00161 events61 affected298 at risk
EG0022 events2 affected796 at risk
EG003
Injection site erythema
General disorders
MedDRA 20.0
Systematic Assessment
EG000173 events170 affected802 at risk
EG00175 events73 affected298 at risk
EG002147 events147 affected796 at risk
EG003
Injection site pain
General disorders
MedDRA 20.0
Systematic Assessment
EG000321 events309 affected802 at risk
EG001125 events118 affected298 at risk
EG002153 events153 affected796 at risk
EG003
Injection site swelling
General disorders
MedDRA 20.0
Systematic Assessment
EG00097 events97 affected802 at risk
EG00132 events31 affected298 at risk
EG00264 events64 affected796 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00027 events25 affected802 at risk
EG0013 events3 affected298 at risk
EG002100 events77 affected796 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG000177 events177 affected802 at risk
EG00167 events67 affected298 at risk
EG002146 events146 affected796 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00061 events61 affected802 at risk
EG00128 events28 affected298 at risk
EG00237 events37 affected796 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG000199 events199 affected802 at risk
EG00173 events73 affected298 at risk
EG0021 events1 affected796 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00028 events27 affected802 at risk
EG00111 events11 affected298 at risk
EG00266 events55 affected796 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D008457
Measles
D009107
Mumps
Ancestor Terms
ID
Term
D018185
Morbillivirus Infections
D018184
Paramyxoviridae Infections
D018701
Mononegavirales Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D007239
Infections
D019351
Rubulavirus Infections
D010309
Parotitis
D010305
Parotid Diseases
D012466
Salivary Gland Diseases
D009059
Mouth Diseases
D009057
Stomatognathic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D022542
Measles-Mumps-Rubella Vaccine
C051021
DTPP vaccine
C050102
measles, mumps, rubella, varicella vaccine
Ancestor Terms
ID
Term
D017778
Vaccines, Combined
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D008458
Measles Vaccine
D014765
Viral Vaccines
D009108
Mumps Vaccine
D012411
Rubella Vaccine
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
1 subjects
FG0050 subjects
1 subjects
FG0050 subjects
31 subjects
FG00511 subjects
4.3
± 0.6
BG0044.4± 0.6
BG0054.4± 0.6
BG0064.3± 0.6
361
BG003153
BG004632
BG005225
BG0061903
Male
BG000404
BG001164
BG002435
BG003150
BG004687
BG005264
BG0062104
48
BG00319
BG00494
BG00532
BG006328
American Indian or Alaskan Native
BG000130
BG00138
BG00215
BG0033
BG0044
BG0050
BG006190
Asian - Central/South Asian Heritage
BG00012
BG0015
BG0027
BG0031
BG0048
BG0050
BG00633
Asian - East Asian Heritage
BG00028
BG0016
BG002384
BG003146
BG004565
BG005209
BG0061338
Asian - Japanese Heritage
BG0003
BG0010
BG0020
BG0031
BG0041
BG0050
BG0065
Asian - South East Asian Heritage
BG00049
BG00125
BG00211
BG0034
BG00416
BG0058
BG006113
Native Hawaiian or Other Pacific Islander
BG0004
BG0012
BG0022
BG0030
BG0043
BG0050
BG00611
Other
BG000112
BG00145
BG00235
BG0039
BG00452
BG00522
BG006275
White - Arabic / North African Heritage
BG0005
BG0013
BG0023
BG0033
BG0041
BG0050
BG00615
White - Caucasian / European Heritage
BG000363
BG001135
BG002291
BG003117
BG004575
BG005218
BG0061699
283
281
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv_MMR_CO Group minus pooled Com_MMR_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.
OG002
OG003
Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.
The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.
Difference in Seroresponse rate (%)
0.71
2-Sided
97.5
0.02
2.97
Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
Com_MMR_I Group
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).
Units
Counts
Participants
OG000698
OG001250
OG002736
OG003283
Title
Denominators
Categories
Title
Measurements
OG000698
OG001250
OG002736
OG003283
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.
The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.
Difference in seroresponse rate (%)
0.00
2-Sided
97.5
-0.72
1.97
Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_CO Group minus pooled Com_MMR_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
OG002
OG003
Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.
The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.
Difference in Seroresponse rate (%)
0.00
2-Sided
97.5
-0.68
1.75
Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
Com_MMR_I Group
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).
Units
Counts
Participants
OG000697
OG001249
OG002736
OG003283
Title
Denominators
Categories
Title
Measurements
OG000696
OG001249
OG002736
OG003283
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.
The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.
Difference in seroresponse rate (%)
-0.14
2-Sided
97.5
-0.98
1.84
Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_CO group minus pooled Com_MMR_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
OG002
OG003
Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.
The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.
Difference in seroresponse rate (%)
0.00
2-Sided
97.5
-0.68
1.75
Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
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).
Units
Counts
Participants
OG000697
OG001249
OG002736
OG003283
Title
Denominators
Categories
Title
Measurements
OG0004335.0(4089.7 to 4594.9)
OG0014215.6(3806.7 to 4668.4)
OG0023646.6(3453.5 to 3850.4)
OG0033503.9(3174.6 to 3867.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Ancova model: adjustment for baseline concentration - pooled variance
Adjusted GMC ratio
0.99
2-Sided
97.5
0.92
1.06
The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
OG002
OG003
ANCOVA
Ancova model: adjustment for baseline concentration country - pooled variance
Adjusted GMC ratio
1.03
2-Sided
97.5
0.96
1.10
The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
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).
Units
Counts
Participants
OG000698
OG001250
OG002736
OG003283
Title
Denominators
Categories
Title
Measurements
OG000170.5(161.6 to 179.9)
OG001190.1(174.7 to 206.8)
OG002167.2(158.6 to 176.3)
OG003176.2(161.5 to 192.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Ancova model: adjustment for baseline concentration - pooled variance
Adjusted GMC ratio
0.91
2-Sided
97.5
0.83
1.00
The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Non-Inferiority or Equivalence (legacy)
The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
OG002
OG003
ANCOVA
Ancova model: adjustment for baseline concentration - pooled variance.
Adjusted GMC ratio
0.96
2-Sided
97.5
0.87
1.06
The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Non-Inferiority or Equivalence (legacy)
The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
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).
Units
Counts
Participants
OG000697
OG001249
OG002736
OG003283
Title
Denominators
Categories
Title
Measurements
OG00096.4(92.6 to 100.4)
OG00196.0(89.5 to 103.0)
OG00298.9(95.3 to 102.8)
OG00398.7(93.2 to 104.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted geometric mean concentration (GMC) ratio (Inv_MMR_CO group divided by Com_MMR_CO group) for antibodies to rubella virus.
ANCOVA
Ancova model: adjustment for baseline concentration - pooled variance.
Adjusted GMC ratio
1.03
2-Sided
97.5
0.97
1.09
The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
OG002
OG003
ANCOVA
Ancova model: adjustment for baseline concentration - pooled variance.
Adjusted GMC ratio
1.01
2-Sided
97.5
0.95
1.07
The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Non-Inferiority or Equivalence (legacy)
Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
OG000695
OG001247
Title
Denominators
Categories
Title
Measurements
OG000693
OG001247
OG000695
OG001247
Title
Denominators
Categories
Title
Measurements
OG000887.7(834.3 to 944.4)
OG001820.4(749.3 to 898.3)
Units
Counts
Participants
OG000661
OG001234
Title
Denominators
Categories
Anti-D
ParticipantsOG000659
ParticipantsOG001233
Title
Measurements
OG000657
OG001233
Anti-T
ParticipantsOG000661
ParticipantsOG001234
Title
Measurements
OG000621
OG001
Units
Counts
Participants
OG000659
OG001233
Title
Denominators
Categories
Title
Measurements
OG000643
OG001225
Units
Counts
Participants
OG000659
OG001234
Title
Denominators
Categories
Title
Measurements
OG000620
OG001221
Units
Counts
Participants
OG000660
OG001234
Title
Denominators
Categories
Title
Measurements
OG000657
OG001233
OG000684
OG001243
Title
Denominators
Categories
Anti-D
Title
Measurements
OG00017.2(16.2 to 18.1)
OG00117.8(16.1 to 19.6)
Anti-T
Title
Measurements
OG0007.4(6.9 to 7.8)
OG0018.4(7.6 to 9.3)
OG000684
OG001243
Title
Denominators
Categories
Anti-PT
ParticipantsOG000684
ParticipantsOG001243
Title
Measurements
OG00076.6(71.6 to 82.0)
OG00173.9(66.2 to 82.4)
Anti-FHA
ParticipantsOG000684
ParticipantsOG001243
Title
Measurements
OG000316.2(299.4 to 334.0)
OG001
Anti-PRN
ParticipantsOG000682
ParticipantsOG001243
Title
Measurements
OG000402.2(370.4 to 436.8)
OG001
684
OG001243
Title
Denominators
Categories
Anti-D
Title
Measurements
OG000684
OG001243
Anti-T
Title
Measurements
OG000684
OG001243
684
OG001243
Title
Denominators
Categories
Anti-D
Title
Measurements
OG000683
OG001242
Anti-T
Title
Measurements
OG000678
OG001243
OG000669
OG001238
Title
Denominators
Categories
Anti-Polio 1
ParticipantsOG000669
ParticipantsOG001238
Title
Measurements
OG0001618.7(1499.8 to 1747.0)
OG0011587.3(1387.3 to 1816.1)
Anti-Polio 2
ParticipantsOG000653
ParticipantsOG001233
Title
Measurements
OG0002026.4(1881.2 to 2182.7)
OG001
Anti-Polio 3
ParticipantsOG000590
ParticipantsOG001214
Title
Measurements
OG0002753.5(2512.4 to 3017.6)
OG001
OG003
Com_MMR_I Group
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).
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
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).
Units
Counts
Participants
OG000727
OG001267
OG002766
OG003289
OG0041289
OG005480
Title
Denominators
Categories
Any Pain
Title
Measurements
OG000295
OG001109
OG002152
OG00364
OG004278
OG005123
Grade 3 Pain
Title
Measurements
OG00022
OG0014
OG0026
OG003
Any Redness
Title
Measurements
OG000157
OG00169
OG002146
OG003
Grade 3 Redness
Title
Measurements
OG0009
OG0014
OG0020
OG003
Any Swelling
Title
Measurements
OG00082
OG00128
OG00264
OG003
Grade 3 Swelling
Title
Measurements
OG0003
OG0013
OG0020
OG003
Counts
Participants
OG000731
OG001268
Title
Denominators
Categories
Any Drowsiness
Title
Measurements
OG000199
OG00172
Grade 3 Drowsiness
Title
Measurements
OG00010
OG0013
Related Drowsiness
Title
Measurements
OG000180
OG00163
Any Loss of appetite
Title
Measurements
OG000154
OG00159
Grade 3 Loss of appetite
Title
Measurements
OG0002
OG0012
Related Loss of appetite
Title
Measurements
OG000135
OG00156
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).
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
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).
Units
Counts
Participants
OG000731
OG001268
OG002767
OG003291
OG0041291
OG005481
Title
Denominators
Categories
Any fever
Title
Measurements
OG000177
OG00167
OG002146
OG00358
OG004257
OG00596
Grade 3 fever
Title
Measurements
OG0007
OG0016
OG00214
OG003
Related fever
Title
Measurements
OG000100
OG00132
OG00227
OG003
OG002
Inv_MMR_I Group
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
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).
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
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).
Units
Counts
Participants
OG000731
OG001268
OG002767
OG003291
OG0041291
OG005481
Title
Denominators
Categories
Any Sign of meningism
Title
Measurements
OG0000
OG0012
OG0021
OG0030
OG0040
OG0050
Grade 3 Sign of meningism
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Sign of meningism
Title
Measurements
OG0000
OG0012
OG0020
OG003
Any Parotid gland swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Parotid gland swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related Parotid gland swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subjects received one dose of Priorix at Visit 1 (Day 0).
OG003
Com_MMR_I Group
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).
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
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).
Units
Counts
Participants
OG000731
OG001268
OG002767
OG003291
OG0041291
OG005481
Title
Denominators
Categories
Any localized or generalized
Title
Measurements
OG00061
OG00128
OG00237
OG00312
OG00456
OG00523
Any with fever
Title
Measurements
OG00011
OG0017
OG0025
OG003
Any Varicella like
Title
Measurements
OG0004
OG0013
OG0020
OG003
Any Measles/Rubella like
Title
Measurements
OG00014
OG0015
OG0023
OG003
Any grade 3
Title
Measurements
OG0003
OG0010
OG0021
OG003
Any related
Title
Measurements
OG00025
OG00111
OG0022
OG003
Localized any
Title
Measurements
OG00050
OG00124
OG00227
OG003
Localized administration site
Title
Measurements
OG0009
OG0012
OG0021
OG003
Localized other site
Title
Measurements
OG00041
OG00122
OG00226
OG003
Localized with fever
Title
Measurements
OG0008
OG0016
OG0024
OG003
Localized Varicella like
Title
Measurements
OG0002
OG0012
OG0020
OG003
Localized Measles/Rubella like
Title
Measurements
OG00012
OG0014
OG0023
OG003
Localized Grade 3
Title
Measurements
OG0002
OG0010
OG0021
OG003
Localized related
Title
Measurements
OG00018
OG00110
OG0022
OG003
Generalized any
Title
Measurements
OG00012
OG0014
OG00210
OG003
Generalized with fever
Title
Measurements
OG0003
OG0011
OG0021
OG003
Generalized Varicella like
Title
Measurements
OG0002
OG0011
OG0020
OG003
Generalized Measles/Rubella like
Title
Measurements
OG0002
OG0011
OG0020
OG003
Generalized Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Generalized Related
Title
Measurements
OG0007
OG0011
OG0020
OG003
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
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).
Units
Counts
Participants
OG000802
OG001298
OG002796
OG003303
OG0041319
OG005489
Title
Denominators
Categories
Title
Measurements
OG0008
OG0014
OG0026
OG0030
OG00411
OG0053
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
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).
Units
Counts
Participants
OG000802
OG001298
OG002796
OG003303
OG0041319
OG005489
Title
Denominators
Categories
Title
Measurements
OG00061
OG00129
OG00264
OG00322
OG004102
OG00536
OG003
Com_MMR_I Group
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).
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
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).
Units
Counts
Participants
OG000802
OG001298
OG002796
OG003303
OG0041319
OG005489
Title
Denominators
Categories
Title
Measurements
OG000276
OG00190
OG002314
OG003112
OG004508
OG005186
Com_MMR_I Group
Subjects received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
OG004
Inv_MMR_S Group
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
OG005
Com_MMR_S Group
Subjects in this safety cohort received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).