Trial Outcomes & Findings for 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 (NCT NCT02184572)
NCT ID: NCT02184572
Last Updated: 2021-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1742 participants
Primary outcome timeframe
During Day 5 to Day 12 post-vaccination period
Results posted on
2021-01-07
Participant Flow
6 subjects from 1742 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started in 1736.
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).
Participant milestones
| Measure |
INV_MMR
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.
|
COM_MMR
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 Study
STARTED
|
1164
|
572
|
|
Overall Study
COMPLETED
|
1117
|
542
|
|
Overall Study
NOT COMPLETED
|
47
|
30
|
Reasons for withdrawal
| Measure |
INV_MMR
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.
|
COM_MMR
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 Study
Lost to Follow-up
|
29
|
21
|
|
Overall Study
Family Out Of Country Until 9/29/2015
|
1
|
0
|
|
Overall Study
Loss Of Kaiser Insurance
|
1
|
0
|
|
Overall Study
2nd blooddraw & diary card incomplete
|
1
|
0
|
|
Overall Study
Traveling Outside The Country
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
9
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
INV_MMR
n=1164 Participants
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.
|
COM_MMR
n=572 Participants
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
n=1736 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.3 Months
STANDARD_DEVIATION 0.7 • n=99 Participants
|
12.3 Months
STANDARD_DEVIATION 0.7 • n=107 Participants
|
12.3 Months
STANDARD_DEVIATION 0.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
551 Participants
n=99 Participants
|
270 Participants
n=107 Participants
|
821 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
613 Participants
n=99 Participants
|
302 Participants
n=107 Participants
|
915 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African Heritage / African American
|
64 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
29 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
131 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
28 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
808 Participants
n=99 Participants
|
385 Participants
n=107 Participants
|
1193 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
89 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During Day 5 to Day 12 post-vaccination periodPopulation: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1126 Participants
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.
|
COM_MMR Group
n=555 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination
> 39.0°C
|
47 Participants
|
17 Participants
|
|
Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination
≥ 38.0°C
|
205 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: At Day 42 post vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1043 Participants
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.
|
COM_MMR Group
n=521 Participants
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.
|
|---|---|---|
|
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
≥ 150 mIU/mL
|
99.3 Percentage of subjects
Interval 98.6 to 99.7
|
96.7 Percentage of subjects
Interval 94.8 to 98.1
|
|
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
≥ 200 mIU/mL
|
99.0 Percentage of subjects
Interval 98.2 to 99.5
|
96.5 Percentage of subjects
Interval 94.6 to 97.9
|
SECONDARY outcome
Timeframe: At Day 42 post vaccinationPopulation: 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.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
Outcome measures
| Measure |
INV_MMR Group
n=1043 Participants
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.
|
COM_MMR Group
n=521 Participants
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.
|
|---|---|---|
|
Anti-measles Virus Antibody Concentrations
|
2751.9 mIU/mL
Interval 2618.3 to 2892.2
|
3133.3 mIU/mL
Interval 2878.6 to 3410.6
|
SECONDARY outcome
Timeframe: At Day 42 post vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=964 Participants
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.
|
COM_MMR Group
n=483 Participants
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.
|
|---|---|---|
|
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
≥ 5 EU/mL
|
99.8 Percentage of subjects
Interval 99.3 to 100.0
|
99.4 Percentage of subjects
Interval 98.2 to 99.9
|
|
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
≥ 10 EU/mL
|
99.4 Percentage of subjects
Interval 98.7 to 99.8
|
97.9 Percentage of subjects
Interval 96.2 to 99.0
|
SECONDARY outcome
Timeframe: At Day 42 post vaccinationPopulation: 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.
Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.
Outcome measures
| Measure |
INV_MMR Group
n=964 Participants
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.
|
COM_MMR Group
n=483 Participants
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.
|
|---|---|---|
|
Anti-mumps Virus Antibody Concentrations
|
86.0 EU/mL
Interval 82.0 to 90.3
|
82.6 EU/mL
Interval 76.5 to 89.2
|
SECONDARY outcome
Timeframe: At Day 42 post vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1043 Participants
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.
|
COM_MMR Group
n=521 Participants
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.
|
|---|---|---|
|
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
≥4 IU/mL
|
99.6 Percentage of subjects
Interval 99.0 to 99.9
|
99.8 Percentage of subjects
Interval 98.9 to 100.0
|
|
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
≥10 IU/mL
|
95.7 Percentage of subjects
Interval 94.3 to 96.8
|
98.3 Percentage of subjects
Interval 96.7 to 99.2
|
SECONDARY outcome
Timeframe: At Day 42 post vaccinationPopulation: 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.
Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.
Outcome measures
| Measure |
INV_MMR Group
n=1043 Participants
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.
|
COM_MMR Group
n=521 Participants
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.
|
|---|---|---|
|
Anti-rubella Virus Antibody Concentrations
|
45.0 IU/mL
Interval 42.8 to 47.2
|
66.8 IU/mL
Interval 62.3 to 71.7
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: 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.
Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
INV_MMR Group
n=1123 Participants
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.
|
COM_MMR Group
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any pain
|
312 Participants
|
131 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any redness (mm)
|
260 Participants
|
137 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any swelling (mm)
|
96 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: During the 15-day (Days 0-14) post-vaccination periodPopulation: 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.
Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
INV_MMR Group
n=1126 Participants
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.
|
COM_MMR Group
n=555 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Solicited General AEs
Any drowsiness
|
527 Participants
|
238 Participants
|
|
Number of Subjects With Any Solicited General AEs
Any irritability/fussiness
|
722 Participants
|
345 Participants
|
|
Number of Subjects With Any Solicited General AEs
Any loss of appetite
|
493 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination periodPopulation: 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.
Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
INV_MMR Group
n=1126 Participants
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.
|
COM_MMR Group
n=555 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any Fever
|
350 Participants
|
179 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination periodPopulation: 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.
Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
INV_MMR Group
n=1126 Participants
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.
|
COM_MMR Group
n=555 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any Rash
Any localized or generalized
|
275 Participants
|
152 Participants
|
|
Number of Subjects Reporting Any Rash
Any with fever
|
100 Participants
|
48 Participants
|
|
Number of Subjects Reporting Any Rash
Any varicella like
|
40 Participants
|
22 Participants
|
|
Number of Subjects Reporting Any Rash
Any measles/rubella like
|
65 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination periodPopulation: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1126 Participants
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.
|
COM_MMR Group
n=555 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting MMR Specific Solicited General AEs
Any parotid gland swelling
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting MMR Specific Solicited General AEs
Any febrile convulsion
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination periodPopulation: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1164 Participants
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.
|
COM_MMR Group
n=572 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any Unsolicited AEs
|
598 Participants
|
277 Participants
|
SECONDARY outcome
Timeframe: Day 0 through the end of the study (Day 180)Population: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1164 Participants
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.
|
COM_MMR Group
n=572 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting AEs of Specific Interest
NOCDs
|
29 Participants
|
11 Participants
|
|
Number of Subjects Reporting AEs of Specific Interest
AEs prompting ER visits
|
166 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Day 0 through the end of the study (Day 180)Population: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1164 Participants
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.
|
COM_MMR Group
n=572 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
|
24 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During Day 5 to Day 12 post-vaccination periodPopulation: 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.
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.
Outcome measures
| Measure |
INV_MMR Group
n=1164 Participants
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.
|
COM_MMR Group
n=572 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Measles-like Illness
Measles-like illness
|
18 Participants
|
5 Participants
|
|
Number of Subjects Reporting Measles-like Illness
Maculopapular rash plus fever and one other event
|
26 Participants
|
9 Participants
|
|
Number of Subjects Reporting Measles-like Illness
Maculopapular rash and fever
|
90 Participants
|
43 Participants
|
Adverse Events
INV_MMR Group
Serious events: 24 serious events
Other events: 980 other events
Deaths: 0 deaths
COM_MMR Group
Serious events: 9 serious events
Other events: 477 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INV_MMR Group
n=1164 participants at risk
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.
|
COM_MMR Group
n=572 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/1164 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1164 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Infections and infestations
Acute sinusitis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/1164 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Infections and infestations
Bronchiolitis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1164 • Number of events 2 • 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.
|
0.35%
2/572 • Number of events 3 • 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.
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Croup infectious
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Exanthema subitum
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/1164 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Gastroenteritis viral
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Influenza
|
0.00%
0/1164 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Infections and infestations
Laryngitis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Otitis media
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Periorbital cellulitis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Pneumonia
|
0.34%
4/1164 • Number of events 4 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Salmonellosis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Staphylococcal infection
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Tonsillitis
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
3/1164 • Number of events 3 • 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.
|
0.00%
0/572 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Nervous system disorders
Febrile convulsion
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Nervous system disorders
Lethargy
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Nervous system disorders
Seizure
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/1164 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.00%
0/572 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.09%
1/1164 • Number of events 1 • 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.
|
0.17%
1/572 • Number of events 1 • 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.
|
Other adverse events
| Measure |
INV_MMR Group
n=1164 participants at risk
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.
|
COM_MMR Group
n=572 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
95/1164 • Number of events 105 • 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.
|
8.0%
46/572 • Number of events 53 • 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.
|
|
Gastrointestinal disorders
Teething
|
5.1%
59/1164 • Number of events 71 • 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.
|
2.6%
15/572 • Number of events 17 • 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.
|
|
General disorders
Injection site erythema
|
24.4%
284/1164 • Number of events 297 • 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.
|
25.0%
143/572 • Number of events 149 • 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.
|
|
General disorders
Injection site pain
|
26.9%
313/1164 • Number of events 314 • 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.
|
23.3%
133/572 • Number of events 133 • 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.
|
|
General disorders
Injection site swelling
|
9.0%
105/1164 • Number of events 108 • 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.
|
10.7%
61/572 • Number of events 62 • 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.
|
|
General disorders
Pyrexia
|
30.1%
350/1164 • Number of events 350 • 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.
|
31.5%
180/572 • Number of events 180 • 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.
|
|
Infections and infestations
Otitis media
|
7.4%
86/1164 • Number of events 95 • 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.
|
6.1%
35/572 • Number of events 36 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
111/1164 • Number of events 119 • 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.
|
12.8%
73/572 • Number of events 75 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.5%
495/1164 • Number of events 497 • 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.
|
40.7%
233/572 • Number of events 234 • 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.
|
|
Nervous system disorders
Somnolence
|
45.4%
529/1164 • Number of events 529 • 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.
|
41.6%
238/572 • Number of events 238 • 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.
|
|
Psychiatric disorders
Irritability
|
62.1%
723/1164 • Number of events 740 • 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.
|
60.8%
348/572 • Number of events 350 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
80/1164 • Number of events 85 • 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.
|
5.2%
30/572 • Number of events 31 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.6%
275/1164 • Number of events 275 • 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.
|
26.6%
152/572 • Number of events 152 • 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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER