Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED) (NCT NCT00985153)
NCT ID: NCT00985153
Last Updated: 2015-11-23
Results Overview
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \< 1.25 gpELISA units/mL at Baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3927 participants
Primary outcome timeframe
6 weeks Postvaccination
Results posted on
2015-11-23
Participant Flow
35 clinical sites in the United States and 5 clinical sites in Canada Date of first participant visit: 12-Apr-2000 Date of last participant visit: 11-May-2001
Participant milestones
| Measure |
ProQuad™ Lot 1
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
985
|
968
|
962
|
1012
|
|
Overall Study
Vaccinated at Visit 1
|
985
|
968
|
962
|
1012
|
|
Overall Study
COMPLETED
|
950
|
924
|
918
|
965
|
|
Overall Study
NOT COMPLETED
|
35
|
44
|
44
|
47
|
Reasons for withdrawal
| Measure |
ProQuad™ Lot 1
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
19
|
17
|
20
|
|
Overall Study
Protocol Violation
|
3
|
2
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
11
|
10
|
|
Overall Study
Missed One or More Bleeds
|
7
|
7
|
8
|
10
|
|
Overall Study
Incomplete Safety Follow-up
|
3
|
5
|
4
|
4
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
Baseline characteristics by cohort
| Measure |
ProQuad™ Lot 1
n=985 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=968 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=962 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=1012 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
Total
n=3927 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.7 Months
STANDARD_DEVIATION 1.3 • n=93 Participants
|
12.8 Months
STANDARD_DEVIATION 1.4 • n=4 Participants
|
12.7 Months
STANDARD_DEVIATION 1.3 • n=27 Participants
|
12.8 Months
STANDARD_DEVIATION 1.4 • n=483 Participants
|
12.7 Months
STANDARD_DEVIATION 1.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
478 Participants
n=93 Participants
|
448 Participants
n=4 Participants
|
442 Participants
n=27 Participants
|
468 Participants
n=483 Participants
|
1836 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
507 Participants
n=93 Participants
|
520 Participants
n=4 Participants
|
520 Participants
n=27 Participants
|
544 Participants
n=483 Participants
|
2091 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African American
|
120 participants
n=93 Participants
|
122 participants
n=4 Participants
|
136 participants
n=27 Participants
|
150 participants
n=483 Participants
|
528 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific
|
49 participants
n=93 Participants
|
59 participants
n=4 Participants
|
40 participants
n=27 Participants
|
43 participants
n=483 Participants
|
191 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
615 participants
n=93 Participants
|
630 participants
n=4 Participants
|
622 participants
n=27 Participants
|
647 participants
n=483 Participants
|
2514 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
150 participants
n=93 Participants
|
113 participants
n=4 Participants
|
116 participants
n=27 Participants
|
119 participants
n=483 Participants
|
498 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native American
|
4 participants
n=93 Participants
|
0 participants
n=4 Participants
|
3 participants
n=27 Participants
|
2 participants
n=483 Participants
|
9 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
47 participants
n=93 Participants
|
44 participants
n=4 Participants
|
45 participants
n=27 Participants
|
51 participants
n=483 Participants
|
187 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer \<1.25 gpELISA units/mL at baseline, and followed protocol procedures.
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \< 1.25 gpELISA units/mL at Baseline
Outcome measures
| Measure |
ProQuad™ Lot 1
n=791 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=761 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=779 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=813 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL
|
726 Participants
|
718 Participants
|
736 Participants
|
772 Participants
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 120 mIU/mL) to Measles at Baseline
Outcome measures
| Measure |
ProQuad™ Lot 1
n=802 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=771 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=779 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=811 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL
|
790 Participants
|
753 Participants
|
753 Participants
|
800 Participants
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 Ab units/mL) to Mumps at Baseline
Outcome measures
| Measure |
ProQuad™ Lot 1
n=856 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=823 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=830 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=872 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL
|
825 Participants
|
796 Participants
|
788 Participants
|
854 Participants
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \< 10 IU/mL) to Rubella at Baseline
Outcome measures
| Measure |
ProQuad™ Lot 1
n=861 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=835 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=836 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=866 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
|
852 Participants
|
821 Participants
|
828 Participants
|
859 Participants
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer \< 1.25 gpELISA units/mL at baseline, and followed protocol procedures.
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Outcome measures
| Measure |
ProQuad™ Lot 1
n=791 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=761 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=779 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=813 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer
|
16.0 gpELISA
Interval 14.9 to 17.2
|
18.4 gpELISA
Interval 17.2 to 19.7
|
19.7 gpELISA
Interval 18.4 to 21.0
|
17.6 gpELISA
Interval 16.6 to 18.7
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
Postvaccination observed Geometric Mean Titer of antibody to Measles.
Outcome measures
| Measure |
ProQuad™ Lot 1
n=802 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=771 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=779 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=811 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer
|
3031.6 mIU/mL
Interval 2841.6 to 3234.3
|
2939.3 mIU/mL
Interval 2740.0 to 3153.2
|
2852.2 mIU/mL
Interval 2651.0 to 3068.7
|
2095.6 mIU/mL
Interval 1964.2 to 2235.7
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
Postvaccination observed Geometric Mean Titer of antibody to Mumps.
Outcome measures
| Measure |
ProQuad™ Lot 1
n=856 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=823 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=830 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=872 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer
|
100.5 ELISA AB units
Interval 94.3 to 107.2
|
102.3 ELISA AB units
Interval 96.0 to 109.0
|
85.6 ELISA AB units
Interval 79.9 to 91.8
|
89.7 ELISA AB units
Interval 84.7 to 94.9
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Outcome measures
| Measure |
ProQuad™ Lot 1
n=861 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=835 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=836 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=866 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer
|
113.5 ELISA AB units
Interval 107.5 to 119.8
|
114.8 ELISA AB units
Interval 108.2 to 121.8
|
114.2 ELISA AB units
Interval 108.1 to 120.6
|
132.6 ELISA AB units
Interval 125.7 to 140.0
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: All subjects with follow-up for safety were included in the analysis.
Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Outcome measures
| Measure |
ProQuad™ Lot 1
n=969 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=950 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=941 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=993 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Serious Vaccine-related CAEs
With Serious Vaccine-Related CAEs
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Serious Vaccine-related CAEs
Without Serious Vaccine-Related CAEs
|
967 Participants
|
949 Participants
|
939 Participants
|
992 Participants
|
Adverse Events
ProQuad™ Lot 1
Serious events: 6 serious events
Other events: 793 other events
Deaths: 0 deaths
ProQuad™ Lot 2
Serious events: 8 serious events
Other events: 758 other events
Deaths: 0 deaths
ProQuad™ Lot 3
Serious events: 11 serious events
Other events: 769 other events
Deaths: 0 deaths
M-M-R™ II + VARIVAX™
Serious events: 11 serious events
Other events: 785 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ProQuad™ Lot 1
n=969 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=950 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=941 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=993 participants at risk
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Breathing Pattern Abnormal
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Nervous system disorders
Seizure, febrile
|
0.21%
2/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.21%
2/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.30%
3/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Nervous system disorders
Seizure disorder
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.20%
2/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Accidental ingestion
|
0.10%
1/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
General disorders
Fever
|
0.10%
1/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.21%
2/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, urinary tract
|
0.10%
1/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Pneumonia
|
0.10%
1/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.42%
4/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.32%
3/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.20%
2/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
0.10%
1/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.32%
3/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.21%
2/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Fracture, humerus, right
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Fracture, radius, right
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.21%
2/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, RSV
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Gastroenteritis, Infectious
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, viral
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.21%
2/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Trauma
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Bite, animal
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
General disorders
Pyelonephritis
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.11%
1/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Drug abuse
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Immune system disorders
Allergy
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.10%
1/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
Other adverse events
| Measure |
ProQuad™ Lot 1
n=969 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
|
ProQuad™ Lot 2
n=950 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
|
ProQuad™ Lot 3
n=941 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
|
M-M-R™ II + VARIVAX™
n=993 participants at risk
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|---|
|
General disorders
Fever
|
39.1%
379/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
38.1%
362/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
40.2%
378/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
32.9%
327/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, Viral
|
4.2%
41/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.1%
29/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.2%
30/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.0%
30/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Trauma
|
1.0%
10/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.2%
11/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
10/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.60%
6/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.9%
18/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.2%
21/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
18/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
20/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.72%
7/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.95%
9/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
10/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.2%
12/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
80/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.4%
80/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.2%
77/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.2%
81/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.9%
18/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.2%
30/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.2%
21/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
20/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Gastroenteritis, Infectious
|
1.3%
13/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.53%
5/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.85%
8/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.5%
15/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
59/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.1%
48/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.2%
58/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.0%
60/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Psychiatric disorders
Irritability
|
10.8%
105/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
10.6%
101/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
12.6%
119/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.7%
86/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
11/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
10/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
16/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.91%
9/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
1.1%
11/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.95%
9/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.64%
6/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.70%
7/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Nasal
|
1.5%
15/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
10/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.5%
14/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
18/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Respiratory
|
1.8%
17/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
13/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
18/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
18/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
57/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.8%
55/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.5%
61/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.1%
61/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, Respiratory, Upper
|
28.9%
280/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
26.1%
248/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
26.5%
249/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
24.7%
245/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Influenza
|
1.0%
10/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.95%
9/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
10/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.81%
8/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngotracheobronchitis
|
0.72%
7/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.63%
6/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
10/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
14/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
2.6%
25/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
15/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.1%
29/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
21/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.0%
58/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.8%
65/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.2%
58/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.0%
60/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.9%
18/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.5%
14/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.85%
8/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
10/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.0%
10/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.74%
7/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.96%
9/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
14/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Bite/Sting, Non-Venomous
|
0.72%
7/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.74%
7/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
15/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.2%
12/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis, Contact
|
2.1%
20/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
15/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
20/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
21/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
18/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
19/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.5%
14/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
19/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Laceration
|
0.41%
4/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.53%
5/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.74%
7/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
10/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Miliaria Rubra
|
1.7%
16/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.5%
24/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.4%
23/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.2%
22/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
59/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.4%
51/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.7%
54/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.5%
45/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Diaper
|
7.4%
72/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.2%
78/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.5%
80/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.7%
86/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Measles/Rubella-Like
|
3.1%
30/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.5%
24/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.6%
24/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
19/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Varicella-Like
|
3.1%
30/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
18/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
15/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.4%
24/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
10/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
15/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.21%
2/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
10/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Viral Exanthema
|
5.6%
54/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.3%
41/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.0%
47/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.5%
45/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Eye disorders
Conjunctivitis
|
2.8%
27/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
12/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.7%
25/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
21/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis
|
3.1%
30/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.8%
27/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
17/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
18/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis Media
|
13.7%
133/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
11.5%
109/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
14.1%
133/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
11.8%
117/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (ProQuad Injection-site)
|
1.8%
17/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.5%
14/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
16/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema (ProQuad Injection-site)
|
15.4%
149/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
17.2%
163/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
17.3%
163/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (ProQuad Injection-site)
|
22.8%
221/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
25.9%
246/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
24.4%
230/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash (ProQuad Injection-site)
|
1.3%
13/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.5%
33/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.7%
35/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling (ProQuad Injection-site)
|
9.2%
89/969
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
9.1%
86/950
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
9.1%
86/941
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (Varivax Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.5%
15/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema (Varivax Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
13.7%
136/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (Varivax Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
26.4%
262/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash (Varivax Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
17/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling (Varivax Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
9.2%
91/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (M-M-R II Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.5%
15/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema (M-M-R II Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
13.5%
134/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (M-M-R II Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
26.8%
266/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling (M-M-R II Injection-site)
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.1%
80/993
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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