Trial Outcomes & Findings for Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines (NCT NCT00984295)
NCT ID: NCT00984295
Last Updated: 2015-08-07
Results Overview
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<120 mIU/mL) to Measles at Baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1913 participants
Primary outcome timeframe
6 Weeks Postvaccination
Results posted on
2015-08-07
Participant Flow
48 clinical sites in the United States Date first participant visit: 27-Jun-2000 Date last participant visit: 23-Oct-2001
Participant milestones
| Measure |
Concomitant Group
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Overall Study
STARTED
|
949
|
485
|
479
|
|
Overall Study
Visit 1
|
949
|
485
|
479
|
|
Overall Study
Visit 2
|
909
|
468
|
453
|
|
Overall Study
COMPLETED
|
884
|
453
|
442
|
|
Overall Study
NOT COMPLETED
|
65
|
32
|
37
|
Reasons for withdrawal
| Measure |
Concomitant Group
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
31
|
12
|
13
|
|
Overall Study
Protocol Violation
|
2
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
18
|
9
|
12
|
|
Overall Study
CAE - discontinued test vaccine
|
0
|
1
|
3
|
|
Overall Study
Missed one or more blood samplings
|
3
|
7
|
2
|
|
Overall Study
Incomplete safety follow-up
|
11
|
2
|
3
|
Baseline Characteristics
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
Baseline characteristics by cohort
| Measure |
Concomitant Group
n=949 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=485 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=479 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Total
n=1913 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
12.3 years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
12.4 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
12.4 years
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
442 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
911 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
507 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
1002 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
101 participants
n=5 Participants
|
52 participants
n=7 Participants
|
42 participants
n=5 Participants
|
195 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific
|
103 participants
n=5 Participants
|
54 participants
n=7 Participants
|
57 participants
n=5 Participants
|
214 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
678 participants
n=5 Participants
|
336 participants
n=7 Participants
|
342 participants
n=5 Participants
|
1356 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
38 participants
n=5 Participants
|
26 participants
n=7 Participants
|
20 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
26 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
60 participants
n=4 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 measles at baseline, and followed protocol procedures.
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<120 mIU/mL) to Measles at Baseline
Outcome measures
| Measure |
Concomitant Group
n=758 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=388 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=126 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL
|
741 Participants
|
383 Participants
|
124 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 mumps at baseline, and followed protocol procedures.
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 Ab units/mL) to Mumps at Baseline
Outcome measures
| Measure |
Concomitant Group
n=811 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=415 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=145 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
|
774 Participants
|
395 Participants
|
143 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 rubella at baseline, and followed protocol procedures.
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline
Outcome measures
| Measure |
Concomitant Group
n=829 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=421 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=148 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
|
817 Participants
|
418 Participants
|
148 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-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<0.6 gpELISA units/mL) to VZV at Baseline
Outcome measures
| Measure |
Concomitant Group
n=757 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=383 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=139 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL
|
679 Participants
|
348 Participants
|
130 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 and followed protocol procedures.
Antibody response to Diphtheria at 6 weeks postvaccination
Outcome measures
| Measure |
Concomitant Group
n=675 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=337 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=95 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL
|
667 Participants
|
333 Participants
|
94 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 and followed protocol procedures.
Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
Outcome measures
| Measure |
Concomitant Group
n=803 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=387 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=114 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
|
796 Participants
|
386 Participants
|
114 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 and followed protocol procedures.
Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
Outcome measures
| Measure |
Concomitant Group
n=748 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=355 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=59 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer
|
554 Participants
|
321 Participants
|
56 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 and followed protocol procedures.
Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
Outcome measures
| Measure |
Concomitant Group
n=748 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=356 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=59 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer
|
502 Participants
|
309 Participants
|
53 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 and followed protocol procedures.
Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
Outcome measures
| Measure |
Concomitant Group
n=825 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=396 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=122 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL
|
791 Participants
|
391 Participants
|
121 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 and followed protocol procedures.
Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Outcome measures
| Measure |
Concomitant Group
n=822 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=398 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=124 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL
|
778 Participants
|
384 Participants
|
119 Participants
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
Outcome measures
| Measure |
Concomitant Group
n=758 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=388 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=126 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
|
3504.9 mIU/mL
Interval 3269.7 to 3757.2
|
3506.2 mIU/mL
Interval 3195.7 to 3846.9
|
2562.1 mIU/mL
Interval 2172.2 to 3022.0
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
Outcome measures
| Measure |
Concomitant Group
n=811 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=415 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=145 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT
|
89.4 ELISA Ab units/mL
Interval 83.5 to 95.7
|
84.1 ELISA Ab units/mL
Interval 76.2 to 92.8
|
98.1 ELISA Ab units/mL
Interval 85.7 to 112.3
|
PRIMARY outcome
Timeframe: 6 weeks PostvaccinationPopulation: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
Outcome measures
| Measure |
Concomitant Group
n=829 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=421 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=148 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT
|
98.7 IU/mL
Interval 92.8 to 105.0
|
99.9 IU/mL
Interval 91.8 to 108.7
|
126.3 IU/mL
Interval 111.9 to 142.6
|
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 and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
Outcome measures
| Measure |
Concomitant Group
n=757 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=383 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=139 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT
|
13.8 gpELISA units/mL
Interval 12.8 to 14.8
|
15.4 gpELISA units/mL
Interval 13.8 to 17.0
|
15.8 gpELISA units/mL
Interval 13.8 to 18.0
|
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 and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)
Outcome measures
| Measure |
Concomitant Group
n=675 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=337 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=95 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT
|
1.33 IU/mL
Interval 1.24 to 1.43
|
1.72 IU/mL
Interval 1.55 to 1.89
|
1.59 IU/mL
Interval 1.29 to 1.97
|
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 and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
Outcome measures
| Measure |
Concomitant Group
n=748 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=355 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=59 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT
|
42.9 units/mL
Interval 39.5 to 46.5
|
55.7 units/mL
Interval 49.7 to 62.4
|
46.3 units/mL
Interval 35.0 to 61.4
|
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 and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)
Outcome measures
| Measure |
Concomitant Group
n=748 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=356 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=59 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT
|
58.1 units/mL
Interval 53.7 to 62.9
|
81.2 units/mL
Interval 73.5 to 89.7
|
65.0 units/mL
Interval 49.6 to 85.2
|
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 and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
Outcome measures
| Measure |
Concomitant Group
n=825 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=396 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=122 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT
|
758 mIU/mL
Interval 658.0 to 874.0
|
996 mIU/mL
Interval 828.0 to 1199.0
|
1135 mIU/mL
Interval 836.0 to 1541.0
|
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 and followed protocol procedures.
Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Outcome measures
| Measure |
Concomitant Group
n=822 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=398 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=124 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT
|
11.2 mIU/mL
Interval 10.1 to 12.3
|
12.1 mIU/mL
Interval 10.6 to 13.7
|
12.9 mIU/mL
Interval 10.4 to 16.1
|
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 and followed protocol procedures.
Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)
Outcome measures
| Measure |
Concomitant Group
n=803 Participants
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=387 Participants
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=114 Participants
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT
|
3.93 IU/mL
Interval 3.59 to 4.31
|
5.74 IU/mL
Interval 5.13 to 6.42
|
4.36 IU/mL
Interval 3.67 to 5.17
|
Adverse Events
Concomitant Group
Serious events: 11 serious events
Other events: 831 other events
Deaths: 0 deaths
Nonconcomitant Group
Serious events: 3 serious events
Other events: 435 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 411 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concomitant Group
n=929 participants at risk
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=479 participants at risk
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=467 participants at risk
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Musculoskeletal and connective tissue disorders
Hernia, inguinal
|
0.00%
0/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Infection, viral
|
0.00%
0/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Immune system disorders
Allergy, food
|
0.11%
1/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Nervous system disorders
Afebrile seizure
|
0.11%
1/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Nervous system disorders
Seizure, febrile
|
0.11%
1/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
2/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngotracheobronchitis
|
0.22%
2/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Pneumonia
|
0.32%
3/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.11%
1/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Cellulitis, orbital
|
0.11%
1/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Reproductive system and breast disorders
Necrosis, testicle
|
0.00%
0/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
Other adverse events
| Measure |
Concomitant Group
n=929 participants at risk
Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
|
Nonconcomitant Group
n=479 participants at risk
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
Control Group
n=467 participants at risk
Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Trauma
|
1.4%
13/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.63%
3/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
17/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.5%
12/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.1%
5/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Gastrointestinal disorders
Constipation
|
0.32%
3/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.1%
5/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
General disorders
Fever
|
31.8%
295/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
29.6%
142/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
29.1%
136/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Infection, Viral
|
4.4%
41/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
5.6%
27/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.9%
18/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
General disorders
Malaise
|
0.54%
5/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.42%
2/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
General disorders
Pain
|
1.2%
11/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.42%
2/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.86%
4/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
88/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
6.9%
33/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
10.3%
48/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
12/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.1%
5/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.9%
18/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.9%
9/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Gastroenteritis, Infectious
|
1.8%
17/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.0%
5/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.5%
7/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
56/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
6.5%
31/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
6.4%
30/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Immune system disorders
Allergy
|
0.97%
9/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Psychiatric disorders
Irritability
|
11.7%
109/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
10.9%
52/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
14.3%
67/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
15/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.1%
5/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
1.2%
11/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.63%
3/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.00%
0/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.75%
7/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.5%
7/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Nasal
|
1.7%
16/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.3%
16/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.9%
9/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, Respiratory
|
3.1%
29/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.7%
13/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.7%
8/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
83/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
9.8%
47/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
9.2%
43/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Infection, Respiratory, Upper
|
27.8%
258/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
27.3%
131/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
23.1%
108/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Influenza
|
0.54%
5/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.63%
3/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.5%
7/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngotracheobronchitis
|
1.3%
12/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.43%
2/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
2.6%
24/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.3%
11/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Reproductive system and breast disorders
Rhinitis
|
1.7%
16/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.9%
14/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.1%
10/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.9%
64/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
6.7%
32/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
8.8%
41/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.0%
19/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.7%
8/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.6%
17/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.2%
11/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.0%
5/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Injury, poisoning and procedural complications
Bite/Sting, Non-Venomous
|
2.2%
20/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.5%
12/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.1%
10/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.54%
5/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.86%
8/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis, Contact
|
1.2%
11/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.1%
10/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.86%
4/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.7%
16/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.5%
7/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.7%
8/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
0.11%
1/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.42%
2/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.1%
5/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Miliaria Rubra
|
4.7%
44/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.3%
16/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.6%
17/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
45/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
4.6%
22/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
5.4%
25/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Rash, Diaper
|
8.8%
82/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
7.7%
37/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
9.2%
43/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Rash, Measles/Rubella-Like
|
2.9%
27/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.3%
16/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.1%
10/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Rash, Varicella-Like
|
1.4%
13/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.5%
12/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.2%
15/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
13/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.3%
6/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Infections and infestations
Viral Exanthema
|
7.6%
71/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
5.2%
25/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
4.9%
23/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Eye disorders
Conjunctivitis
|
2.9%
27/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
4.4%
21/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
3.9%
18/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Ear and labyrinth disorders
Otitis
|
6.5%
60/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
4.0%
19/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.8%
13/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Ear and labyrinth disorders
Otitis Media
|
18.8%
175/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
17.3%
83/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
16.5%
77/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Ear and labyrinth disorders
Pain, Ear
|
0.43%
4/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.63%
3/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.1%
5/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (ProQuad Injection-site)
|
1.8%
17/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
2.1%
10/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Erythema (ProQuad Injection-site)
|
17.8%
165/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
17.3%
83/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (ProQuad Injection-site)
|
33.2%
308/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
25.3%
121/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Rash (ProQuad Injection-site)
|
1.2%
11/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.9%
9/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Swelling (ProQuad Injection-site)
|
12.4%
115/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
10.6%
51/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Erythema (Varivax Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
12.0%
56/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (Varivax Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
25.9%
121/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Swelling (Varivax Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
6.0%
28/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Erythema (M-M-R II Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
13.7%
64/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
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 Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
26.8%
125/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Swelling (M-M-R II Injection-site)
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
—
0/0 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
6.9%
32/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (Tripedia Injection-site)
|
1.1%
10/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.5%
7/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.64%
3/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Erythema (Tripedia Injection-site)
|
26.3%
244/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
23.6%
113/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
23.6%
110/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (Tripedia Injection-site)
|
35.2%
327/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
28.0%
134/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
30.0%
140/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Swelling (Tripedia Injection-site)
|
21.9%
203/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
17.3%
83/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
16.7%
78/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (Comvax Injection-site)
|
1.2%
11/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.84%
4/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.21%
1/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Erythema (Comvax Injection-site)
|
28.6%
266/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
24.6%
118/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
24.2%
113/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Induration (Comvax Injection-site)
|
0.86%
8/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
0.42%
2/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
1.5%
7/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness/Soreness (Comvax Injection-site)
|
35.2%
327/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
29.9%
143/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
29.8%
139/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Swelling (Comvax Injection-site)
|
22.0%
204/929 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
17.5%
84/479 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
17.6%
82/467 • Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up. Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
|
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