Trial Outcomes & Findings for ProQuad Dose Selection Study (V221-011)(COMPLETED) (NCT NCT00986232)
NCT ID: NCT00986232
Last Updated: 2015-04-10
Results Overview
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1551 participants
Primary outcome timeframe
6 weeks postvaccination
Results posted on
2015-04-10
Participant Flow
18 clinical sites in the United States Date first participant visit: 08-Apr-1999 Date last participant visit: 03-Apr-2000
Participant milestones
| Measure |
ProQuad™ (Low Dose)
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose)
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose)
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
387
|
393
|
381
|
390
|
|
Overall Study
Vaccination Visit 1
|
387
|
393
|
381
|
390
|
|
Overall Study
Vaccination Visit 2
|
360
|
365
|
360
|
0
|
|
Overall Study
COMPLETED
|
336
|
343
|
346
|
370
|
|
Overall Study
NOT COMPLETED
|
51
|
50
|
35
|
20
|
Reasons for withdrawal
| Measure |
ProQuad™ (Low Dose)
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose)
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose)
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
19
|
12
|
12
|
7
|
|
Overall Study
Protocol Violation
|
2
|
3
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
16
|
12
|
3
|
|
Overall Study
Missed one or more bleeds
|
13
|
10
|
6
|
7
|
|
Overall Study
Incomplete safety follow-up
|
3
|
7
|
2
|
2
|
Baseline Characteristics
ProQuad Dose Selection Study (V221-011)(COMPLETED)
Baseline characteristics by cohort
| Measure |
ProQuad™ (Low Dose)
n=387 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose)
n=393 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose)
n=381 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)
n=390 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
Total
n=1551 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.9 Months
STANDARD_DEVIATION 1.5 • n=5 Participants
|
12.9 Months
STANDARD_DEVIATION 1.5 • n=7 Participants
|
12.9 Months
STANDARD_DEVIATION 1.5 • n=5 Participants
|
13.0 Months
STANDARD_DEVIATION 1.7 • n=4 Participants
|
12.9 Months
STANDARD_DEVIATION 1.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
720 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
831 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
65 participants
n=5 Participants
|
55 participants
n=7 Participants
|
64 participants
n=5 Participants
|
54 participants
n=4 Participants
|
238 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific
|
19 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
13 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
241 participants
n=5 Participants
|
267 participants
n=7 Participants
|
251 participants
n=5 Participants
|
262 participants
n=4 Participants
|
1021 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
34 participants
n=5 Participants
|
44 participants
n=7 Participants
|
22 participants
n=5 Participants
|
25 participants
n=4 Participants
|
125 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
27 participants
n=5 Participants
|
15 participants
n=7 Participants
|
24 participants
n=5 Participants
|
36 participants
n=4 Participants
|
102 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=310 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=300 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=313 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=303 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=307 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=309 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=320 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
|
198 Participants
|
299 Participants
|
253 Participants
|
303 Participants
|
272 Participants
|
306 Participants
|
298 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer \<207.5 mIU/mL) to measles at baseline
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=324 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=313 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=342 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=328 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=323 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=326 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=350 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
|
321 Participants
|
311 Participants
|
338 Participants
|
327 Participants
|
321 Participants
|
326 Participants
|
349 Participants
|
SECONDARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer \< 2.0 Ab units/mL) to Mumps at baseline
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=334 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=322 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=347 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=331 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=331 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=335 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=351 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
|
333 Participants
|
322 Participants
|
344 Participants
|
330 Participants
|
325 Participants
|
335 Participants
|
350 Participants
|
SECONDARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer \<10 IU/mL) to Rubella at baseline
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=335 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=319 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=347 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=333 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=333 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=335 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=357 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
|
335 Participants
|
319 Participants
|
343 Participants
|
332 Participants
|
326 Participants
|
335 Participants
|
352 Participants
|
SECONDARY outcome
Timeframe: 6 weeks Postvaccination Visit 1 or Visit 2Population: All participants with follow-up for safety were included in the analysis.
Participants 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™ (Low Dose) After 1 Injection
n=378 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=353 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=387 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=361 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=377 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=358 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=381 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
With Serious Vaccine-Related CAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
Without Serious Vaccine-Related CAEs
|
378 Participants
|
353 Participants
|
386 Participants
|
361 Participants
|
377 Participants
|
358 Participants
|
381 Participants
|
SECONDARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=310 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=300 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=313 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=303 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=307 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=309 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=320 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
|
5.7 mcg/mL
Interval 5.0 to 6.5
|
167.7 mcg/mL
Interval 145.6 to 193.2
|
10.5 mcg/mL
Interval 9.4 to 11.7
|
381.0 mcg/mL
Interval 335.8 to 432.4
|
11.9 mcg/mL
Interval 10.8 to 13.1
|
469.4 mcg/mL
Interval 405.5 to 543.4
|
16.5 mcg/mL
Interval 15.1 to 18.1
|
SECONDARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=324 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=313 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=342 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=328 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=323 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=326 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=350 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
|
251.8 mcg/mL
Interval 229.9 to 275.8
|
549.7 mcg/mL
Interval 484.8 to 623.4
|
309.5 mcg/mL
Interval 280.8 to 341.3
|
783.0 mcg/mL
Interval 681.8 to 899.1
|
315.4 mcg/mL
Interval 286.4 to 347.3
|
747.9 mcg/mL
Interval 656.9 to 851.7
|
253.5 mcg/mL
Interval 230.5 to 278.8
|
SECONDARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=334 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=322 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=347 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=331 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=331 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=335 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=351 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
|
102.0 mcg/mL
Interval 90.0 to 115.7
|
277.7 mcg/mL
Interval 252.0 to 305.9
|
106.3 mcg/mL
Interval 94.4 to 119.8
|
244.1 mcg/mL
Interval 220.3 to 270.3
|
114.7 mcg/mL
Interval 101.3 to 130.0
|
286.0 mcg/mL
Interval 259.2 to 315.7
|
97.4 mcg/mL
Interval 87.5 to 108.5
|
SECONDARY outcome
Timeframe: 6 weeks postvaccinationPopulation: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)
Outcome measures
| Measure |
ProQuad™ (Low Dose) After 1 Injection
n=335 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Low Dose) After 2 Injections
n=319 Participants
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 1 Injection
n=347 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (Middle Dose) After 2 Injections
n=333 Participants
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 1 Injection
n=333 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad™ (High Dose) After 2 Injections
n=335 Participants
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV After 1 Injection
n=357 Participants
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
|
131.4 mcg/mL
Interval 119.6 to 144.5
|
263.7 mcg/mL
Interval 239.0 to 291.0
|
122.5 mcg/mL
Interval 110.7 to 135.5
|
230.7 mcg/mL
Interval 207.8 to 256.0
|
115.5 mcg/mL
Interval 104.9 to 127.2
|
254.2 mcg/mL
Interval 230.5 to 280.3
|
128.5 mcg/mL
Interval 116.5 to 141.7
|
Adverse Events
ProQuad (Low Dose) After Injection 1
Serious events: 2 serious events
Other events: 286 other events
Deaths: 0 deaths
ProQuad (Middle Dose) After Injection 1
Serious events: 3 serious events
Other events: 286 other events
Deaths: 0 deaths
ProQuad (High Dose) After Injection 1
Serious events: 1 serious events
Other events: 289 other events
Deaths: 0 deaths
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)
Serious events: 1 serious events
Other events: 297 other events
Deaths: 0 deaths
ProQuad (Low Dose) After Injection 2
Serious events: 1 serious events
Other events: 253 other events
Deaths: 0 deaths
ProQuad (Middle Dose) After Injection 2
Serious events: 0 serious events
Other events: 258 other events
Deaths: 0 deaths
ProQuad (High Dose) After Injection 2
Serious events: 2 serious events
Other events: 254 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ProQuad (Low Dose) After Injection 1
n=378 participants at risk
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (Middle Dose) After Injection 1
n=387 participants at risk
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (High Dose) After Injection 1
n=377 participants at risk
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)
n=381 participants at risk
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
ProQuad (Low Dose) After Injection 2
n=353 participants at risk
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (Middle Dose) After Injection 2
n=361 participants at risk
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (High Dose) After Injection 2
n=358 participants at risk
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
General disorders
Fever
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Nervous system disorders
Seizure, febrile
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngotracheobronchitis
|
0.26%
1/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress, newborn
|
0.26%
1/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
1/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
Other adverse events
| Measure |
ProQuad (Low Dose) After Injection 1
n=378 participants at risk
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (Middle Dose) After Injection 1
n=387 participants at risk
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (High Dose) After Injection 1
n=377 participants at risk
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)
n=381 participants at risk
One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
|
ProQuad (Low Dose) After Injection 2
n=353 participants at risk
One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (Middle Dose) After Injection 2
n=361 participants at risk
One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
ProQuad (High Dose) After Injection 2
n=358 participants at risk
One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Asthenia/Fatigue
|
0.53%
2/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
General disorders
Candidiasis
|
0.26%
1/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
General disorders
Fever
|
30.7%
116/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
33.1%
128/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
38.5%
145/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
35.7%
136/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
22.9%
81/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
27.1%
98/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
27.7%
99/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, Viral
|
3.2%
12/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.1%
16/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.2%
16/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.7%
14/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.8%
10/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.0%
11/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.9%
14/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
General disorders
Malaise
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.57%
2/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Trauma
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.57%
2/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.83%
3/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.84%
3/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
8/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.6%
10/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
6/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
6/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.85%
3/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Candidiasis, Oral
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.55%
2/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
6/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.53%
2/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.85%
3/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
9.0%
34/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.9%
23/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.2%
31/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.1%
31/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.4%
19/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
7.2%
26/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.5%
16/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Flatulence
|
0.26%
1/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.26%
1/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.78%
3/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
5/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
5/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis, Infectious
|
2.1%
8/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.57%
2/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.84%
3/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
12/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.1%
16/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.6%
21/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.0%
23/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.4%
19/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.7%
17/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.4%
23/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.26%
1/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Immune system disorders
Allergy
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.80%
3/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.79%
3/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Nervous system disorders
Crying
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.79%
3/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.57%
2/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.84%
3/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Psychiatric disorders
Irritability
|
13.8%
52/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
12.7%
49/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
13.5%
51/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
11.0%
42/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.2%
29/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
7.8%
28/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.1%
29/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Psychiatric disorders
Somnolence
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
6/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.80%
3/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.6%
13/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
0.79%
3/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.55%
2/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Nasal
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.6%
10/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.4%
9/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.83%
3/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Respiratory
|
1.6%
6/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.6%
14/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
7/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.7%
13/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.5%
20/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.8%
10/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
21/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.2%
20/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.3%
20/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.6%
25/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
7.4%
26/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
9.1%
33/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.9%
32/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Infection, Respiratory, Upper
|
15.9%
60/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
15.0%
58/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
17.8%
67/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
16.8%
64/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
23.2%
82/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
30.5%
110/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
26.0%
93/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Influenza
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.80%
3/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
5/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.55%
2/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
5/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngotracheobronchitis
|
0.79%
3/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.78%
3/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.3%
8/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
7/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
1.6%
6/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.7%
10/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.4%
13/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
7/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.1%
11/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.79%
3/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.83%
3/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.53%
2/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.53%
2/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.26%
1/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.57%
2/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.83%
3/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.84%
3/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.4%
28/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.8%
34/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
10.1%
38/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
10.8%
41/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
7.9%
28/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.0%
29/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
7.5%
27/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.3%
5/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.80%
3/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.3%
8/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
7/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
7/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Bite/Sting, Non-Venomous
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.3%
9/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.84%
3/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.85%
3/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis, Contact
|
1.6%
6/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.78%
3/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
7/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.57%
2/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
7/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
6/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.0%
4/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Miliaria Rubra
|
2.6%
10/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.3%
9/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.9%
11/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
7/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.85%
3/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
11/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.9%
15/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.9%
11/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.0%
19/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
7/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.6%
13/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.4%
12/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Diaper
|
4.2%
16/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.7%
14/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
7/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
7/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Measles/Rubella-Like
|
3.4%
13/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.7%
18/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.8%
18/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.7%
14/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.55%
2/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash, Varicella-Like
|
2.1%
8/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
3.1%
12/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.9%
11/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.55%
2/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.79%
3/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.78%
3/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Infections and infestations
Viral Exanthema
|
3.7%
14/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.1%
16/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.0%
15/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
4.7%
18/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.5%
9/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Eye disorders
Conjunctivitis
|
1.6%
6/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.6%
10/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.7%
10/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.6%
10/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
5/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.4%
5/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis
|
2.6%
10/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
7/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.6%
6/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.8%
10/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.83%
3/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.0%
7/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis Media
|
9.0%
34/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
9.6%
37/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
9.0%
34/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
11.0%
42/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
15.0%
53/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
13.3%
48/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
16.5%
59/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Otitis Media, Serous
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.27%
1/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.79%
3/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.7%
6/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.00%
0/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Ear and labyrinth disorders
Pain, Ear
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.52%
2/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.53%
2/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.79%
3/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.85%
3/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.83%
3/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (ProQuad Injection-site)
|
1.1%
4/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.1%
4/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema (ProQuad Injection-site)
|
12.7%
48/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
11.1%
43/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.5%
32/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
10.2%
36/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
12.7%
46/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
10.6%
38/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
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)
|
22.2%
84/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
18.1%
70/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
20.7%
78/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
16.1%
57/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
14.4%
52/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
14.2%
51/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash (ProQuad Injection-site)
|
1.9%
7/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.9%
7/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.57%
2/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.28%
1/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
0.56%
2/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling (ProQuad Injection-site)
|
7.7%
29/378 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.9%
23/387 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.0%
30/377 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.8%
31/353 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
6.1%
22/361 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
5.9%
21/358 • Participants were followed for safety for 42 days after each scheduled vaccination.
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 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.3%
5/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
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 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
14.7%
56/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
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 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
23.6%
90/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
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 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
9.4%
36/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (PUVV Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
2.1%
8/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema (PUVV Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
12.6%
48/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (PUVV Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
22.3%
85/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash (PUVV Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
1.8%
7/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
|
Skin and subcutaneous tissue disorders
Swelling (PUVV Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
8.4%
32/381 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
Number of participants reported as "At Risk" is the number of participants with follow-up.
|
—
0/0 • Participants were followed for safety for 42 days after each scheduled vaccination.
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
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