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

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ClinicalTrials.gov Identifier: NCT02184572
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Measles; Mumps; Rubella
Interventions Biological: Priorix
Biological: M-M-R II
Biological: Varivax
Biological: Havrix
Biological: Prevnar 13
Enrollment 1742
Recruitment Details 6 subjects from 1742 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started in 1736.
Pre-assignment Details US sub-cohort: Subjects recruited in US received INV_MMR (Priorix) or COM_MMR (M-M-R II/M-M-R VaxPro) co-administered with Varivax, Havrix & Prevnar 13 vaccines (Day 0). Non-US sub-cohort: Subjects recruited outside the US received INV_MMR (Priorix) or COM_MMR (M-M-R II/M-M-R VaxPro) co-administered with Varivax & Havrix vaccines (Day 0).
Arm/Group Title INV_MMR COM_MMR
Hide Arm/Group Description Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0. Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Period Title: Overall Study
Started 1164 572
Completed 1117 542
Not Completed 47 30
Reason Not Completed
Lost to Follow-up             29             21
Family Out Of Country Until 9/29/2015             1             0
Loss Of Kaiser Insurance             1             0
2nd blooddraw & diary card incomplete             1             0
Traveling Outside The Country             1             0
Withdrawal by Subject             14             9
Arm/Group Title INV_MMR COM_MMR Total
Hide Arm/Group Description Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0. Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 1164 572 1736
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 1164 participants 572 participants 1736 participants
12.3  (0.7) 12.3  (0.7) 12.3  (0.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1164 participants 572 participants 1736 participants
Female
551
  47.3%
270
  47.2%
821
  47.3%
Male
613
  52.7%
302
  52.8%
915
  52.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1164 participants 572 participants 1736 participants
African Heritage / African American 64 38 102
American Indian or Alaskan Native 29 16 45
Asian - Central/South Asian Heritage 9 4 13
Asian - East Asian Heritage 131 65 196
Asian - Japanese Heritage 2 0 2
Asian - South East Asian Heritage 28 12 40
Native Hawaiian or Other Pacific Islander 1 2 3
White - Arabic / North African Heritage 3 3 6
White - Caucasian / European Heritage 808 385 1193
Other 89 47 136
1.Primary Outcome
Title Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination
Hide Description Fever was assessed for temperature equal to/above (≥) 38.0°C and above (>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.
Time Frame During Day 5 to Day 12 post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Total Vaccinated cohort (TVC) which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1126 555
Measure Type: Count of Participants
Unit of Measure: Participants
> 39.0°C
47
   4.2%
17
   3.1%
≥ 38.0°C
205
  18.2%
95
  17.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Difference between groups (INV_MMR Group minus COM_MMR Group) in incidence of fever > 39.0°C.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV_MMR minus COM_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.
Method of Estimation Estimation Parameter Difference in incidence of fever
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
-0.93 to 2.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Difference between groups (INV_MMR Group minus COM_MMR Group) in incidence of fever > 38.0°C.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV_MMR minus COM_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.
Method of Estimation Estimation Parameter Difference in incidence of fever
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
-2.89 to 4.85
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before vaccination.
Time Frame At Day 42 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1043 521
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
≥ 150 mIU/mL
99.3
(98.6 to 99.7)
96.7
(94.8 to 98.1)
≥ 200 mIU/mL
99.0
(98.2 to 99.5)
96.5
(94.6 to 97.9)
3.Secondary Outcome
Title Anti-measles Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
Time Frame At Day 42 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1043 521
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
2751.9
(2618.3 to 2892.2)
3133.3
(2878.6 to 3410.6)
4.Secondary Outcome
Title Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration < 5 EU/mL) before vaccination.
Time Frame At Day 42 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 964 483
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
≥ 5 EU/mL
99.8
(99.3 to 100)
99.4
(98.2 to 99.9)
≥ 10 EU/mL
99.4
(98.7 to 99.8)
97.9
(96.2 to 99.0)
5.Secondary Outcome
Title Anti-mumps Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.
Time Frame At Day 42 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps, or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 964 483
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
86.0
(82.0 to 90.3)
82.6
(76.5 to 89.2)
6.Secondary Outcome
Title Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration < 4 IU/mL) before vaccination.
Time Frame At Day 42 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1043 521
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
≥4 IU/mL
99.6
(99.0 to 99.9)
99.8
(98.9 to 100)
≥10 IU/mL
95.7
(94.3 to 96.8)
98.3
(96.7 to 99.2)
7.Secondary Outcome
Title Anti-rubella Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.
Time Frame At Day 42 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1043 521
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
45.0
(42.8 to 47.2)
66.8
(62.3 to 71.7)
8.Secondary Outcome
Title Number of Subjects With Any Solicited Local Adverse Events (AEs)
Hide Description Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1123 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any pain
312
  27.8%
131
  23.7%
Any redness (mm)
260
  23.2%
137
  24.8%
Any swelling (mm)
96
   8.5%
58
  10.5%
9.Secondary Outcome
Title Number of Subjects With Any Solicited General AEs
Hide Description Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time Frame During the 15-day (Days 0-14) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1126 555
Measure Type: Count of Participants
Unit of Measure: Participants
Any drowsiness
527
  46.8%
238
  42.9%
Any irritability/fussiness
722
  64.1%
345
  62.2%
Any loss of appetite
493
  43.8%
232
  41.8%
10.Secondary Outcome
Title Number of Subjects Reporting Any Fever
Hide Description Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1126 555
Measure Type: Count of Participants
Unit of Measure: Participants
350
  31.1%
179
  32.3%
11.Secondary Outcome
Title Number of Subjects Reporting Any Rash
Hide Description Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1126 555
Measure Type: Count of Participants
Unit of Measure: Participants
Any localized or generalized
275
  24.4%
152
  27.4%
Any with fever
100
   8.9%
48
   8.6%
Any varicella like
40
   3.6%
22
   4.0%
Any measles/rubella like
65
   5.8%
26
   4.7%
12.Secondary Outcome
Title Number of Subjects Reporting MMR Specific Solicited General AEs
Hide Description Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1126 555
Measure Type: Count of Participants
Unit of Measure: Participants
Any parotid gland swelling
0
   0.0%
0
   0.0%
Any febrile convulsion
2
   0.2%
0
   0.0%
13.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited AEs
Hide Description Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any ‘solicited’ AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1164 572
Measure Type: Count of Participants
Unit of Measure: Participants
598
  51.4%
277
  48.4%
14.Secondary Outcome
Title Number of Subjects Reporting AEs of Specific Interest
Hide Description AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.
Time Frame Day 0 through the end of the study (Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1164 572
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs
29
   2.5%
11
   1.9%
AEs prompting ER visits
166
  14.3%
55
   9.6%
15.Secondary Outcome
Title Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Hide Description SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time Frame Day 0 through the end of the study (Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR COM_MMR
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1164 572
Measure Type: Count of Participants
Unit of Measure: Participants
24
   2.1%
9
   1.6%
16.Secondary Outcome
Title Number of Subjects Reporting Measles-like Illness
Hide Description

Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:

maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.

Time Frame During Day 5 to Day 12 post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
Overall Number of Participants Analyzed 1164 572
Measure Type: Count of Participants
Unit of Measure: Participants
Measles-like illness
18
   1.5%
5
   0.9%
Maculopapular rash plus fever and one other event
26
   2.2%
9
   1.6%
Maculopapular rash and fever
90
   7.7%
43
   7.5%
Time Frame SAEs = From Day 0 to study end (Day 180); Solicited local and general AEs = During the 4-day (Day 0-3) and 15-day (Day 0-14) post vaccination period, respectively; Unsolicited adverse events = During the 43-day (Day 0-42) post vaccination period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0. Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.
All-Cause Mortality
INV_MMR Group COM_MMR Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1164 (0.00%)      0/572 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
INV_MMR Group COM_MMR Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/1164 (2.06%)      9/572 (1.57%)    
Blood and lymphatic system disorders     
Immune thrombocytopenic purpura  1  0/1164 (0.00%)  0 1/572 (0.17%)  1
Leukopenia  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Gastrointestinal disorders     
Gastritis  1  0/1164 (0.00%)  0 1/572 (0.17%)  1
Infections and infestations     
Acute sinusitis  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Bacterial infection  1  0/1164 (0.00%)  0 1/572 (0.17%)  1
Bronchiolitis  1  1/1164 (0.09%)  1 1/572 (0.17%)  1
Bronchitis  1  1/1164 (0.09%)  2 2/572 (0.35%)  3
Cellulitis  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Croup infectious  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Exanthema subitum  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Fungal skin infection  1  0/1164 (0.00%)  0 1/572 (0.17%)  1
Gastroenteritis  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Gastroenteritis norovirus  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Gastroenteritis salmonella  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Gastroenteritis viral  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Hand-foot-and-mouth disease  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Influenza  1  0/1164 (0.00%)  0 1/572 (0.17%)  1
Laryngitis  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Otitis media  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Parainfluenzae virus infection  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Periorbital cellulitis  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Pneumonia  1  4/1164 (0.34%)  4 1/572 (0.17%)  1
Pneumonia respiratory syncytial viral  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Respiratory syncytial virus infection  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Salmonellosis  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Staphylococcal infection  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Tonsillitis  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Upper respiratory tract infection  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Injury, poisoning and procedural complications     
Limb injury  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  3/1164 (0.26%)  3 0/572 (0.00%)  0
Hypoglycaemia  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Hypovolaemia  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint effusion  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Nervous system disorders     
Febrile convulsion  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Lethargy  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Seizure  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchial hyperreactivity  1  0/1164 (0.00%)  0 1/572 (0.17%)  1
Obstructive airways disorder  1  1/1164 (0.09%)  1 0/572 (0.00%)  0
Respiratory distress  1  1/1164 (0.09%)  1 1/572 (0.17%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
INV_MMR Group COM_MMR Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   980/1164 (84.19%)      477/572 (83.39%)    
Gastrointestinal disorders     
Diarrhoea  1  95/1164 (8.16%)  105 46/572 (8.04%)  53
Teething  1  59/1164 (5.07%)  71 15/572 (2.62%)  17
General disorders     
Injection site erythema  1  284/1164 (24.40%)  297 143/572 (25.00%)  149
Injection site pain  1  313/1164 (26.89%)  314 133/572 (23.25%)  133
Injection site swelling  1  105/1164 (9.02%)  108 61/572 (10.66%)  62
Pyrexia  1  350/1164 (30.07%)  350 180/572 (31.47%)  180
Infections and infestations     
Otitis media  1  86/1164 (7.39%)  95 35/572 (6.12%)  36
Upper respiratory tract infection  1  111/1164 (9.54%)  119 73/572 (12.76%)  75
Metabolism and nutrition disorders     
Decreased appetite  1  495/1164 (42.53%)  497 233/572 (40.73%)  234
Nervous system disorders     
Somnolence  1  529/1164 (45.45%)  529 238/572 (41.61%)  238
Psychiatric disorders     
Irritability  1  723/1164 (62.11%)  740 348/572 (60.84%)  350
Respiratory, thoracic and mediastinal disorders     
Cough  1  80/1164 (6.87%)  85 30/572 (5.24%)  31
Skin and subcutaneous tissue disorders     
Rash  1  275/1164 (23.63%)  275 152/572 (26.57%)  152
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02184572     History of Changes
Other Study ID Numbers: 115650
2011-006161-18 ( EudraCT Number )
First Submitted: July 3, 2014
First Posted: July 9, 2014
Results First Submitted: December 27, 2016
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018