Trial Outcomes & Findings for ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED) (NCT NCT00975507)
NCT ID: NCT00975507
Last Updated: 2015-10-06
Results Overview
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
480 participants
Primary outcome timeframe
6 weeks Postvaccination
Results posted on
2015-10-06
Participant Flow
2 clinical sites in the United States Date of first participant visit: 24-Mar-1998 Date of last participant visit: 05-Jan-1999
Participant milestones
| Measure |
ProQuad™ + Placebo Followed by ProQuad™
ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
|
M-M-R™ II + VARIVAX™
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
323
|
157
|
|
Overall Study
Vaccinated at Visit 1
|
323
|
157
|
|
Overall Study
Vaccinated at Visit 2
|
310
|
0
|
|
Overall Study
COMPLETED
|
303
|
153
|
|
Overall Study
NOT COMPLETED
|
20
|
4
|
Reasons for withdrawal
| Measure |
ProQuad™ + Placebo Followed by ProQuad™
ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
|
M-M-R™ II + VARIVAX™
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
3
|
Baseline Characteristics
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
Baseline characteristics by cohort
| Measure |
ProQuad™ + Placebo Followed by ProQuad™
n=323 Participants
ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
|
M-M-R™ II + VARIVAX™
n=157 Participants
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.1 Months
STANDARD_DEVIATION 1.9 • n=93 Participants
|
14.0 Months
STANDARD_DEVIATION 1.7 • n=4 Participants
|
14.1 Months
STANDARD_DEVIATION 1.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
260 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
220 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American
|
41 participants
n=93 Participants
|
21 participants
n=4 Participants
|
62 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific
|
30 participants
n=93 Participants
|
9 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
211 participants
n=93 Participants
|
107 participants
n=4 Participants
|
318 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
30 participants
n=93 Participants
|
16 participants
n=4 Participants
|
46 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 participants
n=93 Participants
|
4 participants
n=4 Participants
|
15 participants
n=27 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 varicella at baseline, and followed protocol procedures.
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline
Outcome measures
| Measure |
ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)
n=250 Participants
|
ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)
n=239 Participants
|
M-M-R™ II + VARIVAX™ (1 Injection)
n=128 Participants
|
|---|---|---|---|
|
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
|
228 Participants
|
237 Participants
|
118 Participants
|
SECONDARY 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 \<207.8 mIU/mL) to Measles at Baseline
Outcome measures
| Measure |
ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)
n=302 Participants
|
ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)
n=288 Participants
|
M-M-R™ II + VARIVAX™ (1 Injection)
n=145 Participants
|
|---|---|---|---|
|
Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
|
290 Participants
|
284 Participants
|
145 Participants
|
SECONDARY 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™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)
n=290 Participants
|
ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)
n=278 Participants
|
M-M-R™ II + VARIVAX™ (1 Injection)
n=145 Participants
|
|---|---|---|---|
|
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
|
264 Participants
|
275 Participants
|
134 Participants
|
SECONDARY 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 \<2.0 Ab Units/mL) to Mumps at Baseline
Outcome measures
| Measure |
ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)
n=295 Participants
|
ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)
n=283 Participants
|
M-M-R™ II + VARIVAX™ (1 Injection)
n=150 Participants
|
|---|---|---|---|
|
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
|
292 Participants
|
283 Participants
|
148 Participants
|
SECONDARY 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™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)
n=304 Participants
|
ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)
n=290 Participants
|
M-M-R™ II + VARIVAX™ (1 Injection)
n=153 Participants
|
|---|---|---|---|
|
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
|
289 Participants
|
275 Participants
|
142 Participants
|
Adverse Events
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)
Serious events: 0 serious events
Other events: 238 other events
Deaths: 0 deaths
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)
Serious events: 1 serious events
Other events: 190 other events
Deaths: 0 deaths
M-M-R™ II + VARIVAX™ (1 Injection)
Serious events: 1 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)
n=321 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0.
|
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)
n=308 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
|
M-M-R™ II + VARIVAX™ (1 Injection)
n=156 participants at risk
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.64%
1/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.64%
1/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, rotovirus
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.64%
1/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, viral
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.32%
1/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
Other adverse events
| Measure |
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)
n=321 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0.
|
ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)
n=308 participants at risk
ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (\~40,000 PFU/0.5 mL-dose) with a standard measles component (\~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
|
M-M-R™ II + VARIVAX™ (1 Injection)
n=156 participants at risk
VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
|
|---|---|---|---|
|
General disorders
Fever
|
40.2%
129/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
23.4%
72/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
34.6%
54/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, Viral
|
2.5%
8/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
6/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
4.5%
7/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Trauma
|
0.31%
1/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
4/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Hemorrhage, Venipuncture Site
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.4%
14/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
2.6%
8/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.64%
1/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
9.0%
29/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
6.2%
19/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
8.3%
13/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.2%
4/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.97%
3/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Infections and infestations
Gastroenteritis, Infectious
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.32%
1/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
4/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Stomatitis
|
0.31%
1/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.65%
2/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
18/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.6%
5/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
7.7%
12/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Nervous system disorders
Headache
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Psychiatric disorders
Insomnia
|
1.9%
6/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.97%
3/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Psychiatric disorders
Irritability
|
12.1%
39/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
7.5%
23/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
10.3%
16/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Psychiatric disorders
Somnolence
|
1.2%
4/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.65%
2/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.65%
2/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Nasal
|
0.31%
1/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
3.6%
11/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Respiratory
|
3.7%
12/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
3.6%
11/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
2.6%
4/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
21/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
8.1%
25/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
3.8%
6/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, Respiratory, Upper
|
10.6%
34/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
23.7%
73/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
7.1%
11/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.93%
3/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
6/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
6/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.6%
18/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
5.8%
18/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
5.1%
8/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.31%
1/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
2.3%
7/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.2%
4/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.65%
2/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.93%
3/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.6%
5/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Bite/Sting, Non-Venomous
|
1.9%
6/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.32%
1/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.32%
1/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis, Contact
|
1.6%
5/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.32%
1/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.64%
1/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatomycosis
|
0.62%
2/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
7/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.65%
2/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Miliaria Rubra
|
2.8%
9/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.32%
1/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
5.1%
8/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.0%
29/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
4.2%
13/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
10.3%
16/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Measles/Rubella-Like
|
5.6%
18/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
4/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Varicella-Like
|
2.2%
7/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
6/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.6%
5/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Viral Exanthema
|
5.3%
17/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
4/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
5.8%
9/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Eye disorders
Conjunctivitis
|
1.2%
4/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.6%
5/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.64%
1/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis
|
5.9%
19/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
4.2%
13/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
2.6%
4/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema (ProQuad Injection-site)
|
2.8%
9/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
2.3%
7/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (ProQuad Injection-site)
|
2.8%
9/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
2.9%
9/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash (ProQuad Injection-site)
|
1.6%
5/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.00%
0/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling (ProQuad Injection-site)
|
1.9%
6/321
The number of participants listed as "at risk" is the number of participants with follow-up.
|
0.97%
3/308
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (Varivax Injection-site)
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
3.2%
5/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema (Varivax Injection-site)
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
5.1%
8/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (Varivax Injection-site)
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed as "at risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling (Varivax Injection-site)
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.3%
2/156
The number of participants listed 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
The number of participants listed as "at risk" is the number of participants with follow-up.
|
—
0/0
The number of participants listed as "at risk" is the number of participants with follow-up.
|
1.9%
3/156
The number of participants listed 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
Email: [email protected]
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