Trial Outcomes & Findings for Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children (NCT NCT06038617)
NCT ID: NCT06038617
Last Updated: 2026-05-13
Results Overview
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
347 participants
Primary outcome timeframe
2 Days Post-Administration
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Simultaneous Vaccination Arm
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
171
|
|
Overall Study
COMPLETED
|
174
|
168
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Simultaneous Vaccination Arm
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
Baseline characteristics by cohort
| Measure |
Simultaneous Vaccination Arm
n=174 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.5 months
n=1512 Participants
|
12.5 months
n=504 Participants
|
12.5 months
n=2016 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=1512 Participants
|
80 Participants
n=504 Participants
|
157 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=1512 Participants
|
88 Participants
n=504 Participants
|
185 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=1512 Participants
|
49 Participants
n=504 Participants
|
104 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=1512 Participants
|
118 Participants
n=504 Participants
|
236 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
White
|
95 Participants
n=1512 Participants
|
83 Participants
n=504 Participants
|
178 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=1512 Participants
|
23 Participants
n=504 Participants
|
41 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 Participants
n=1512 Participants
|
32 Participants
n=504 Participants
|
60 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
2 or More Races
|
28 Participants
n=1512 Participants
|
26 Participants
n=504 Participants
|
54 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: 2 Days Post-AdministrationPopulation: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=169 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=166 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Fever Following Vaccination
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 1Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=169 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=165 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Fever Following Visit 1
|
13 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 2Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=162 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=155 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Fever Following Visit 2
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post AdministrationPopulation: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=169 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=166 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 1Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=169 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=165 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Grade 2 and/or 3 Fever Following Visit 1
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 2Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=162 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=155 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Grade 2 and/or 3 Fever Following Visit 2
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post AdministrationPopulation: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with medical care utilization (medical advice (telephone, patient portal), urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and /or day 2 following Visit 1 and Visit 2 combined.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=174 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Medical Care Utilization for Fever - Visit 1 and Visit 2 Combined
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 1Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 1.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=174 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Medical Care Utilization for Fever - Visit 1
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 2Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 2.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=174 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Medical Care Utilization for Fever- Visit 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post AdministrationPopulation: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children who received antipyretics on day 1 and/or day 2 following Visit 1 and Visit 2 combined.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=174 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants Who Received Antipyretics - Visit 1 and Visit 2 Combined
|
24 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 1Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children who received antipyretics on day 1 and/or day 2 following Visit 1.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=169 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=165 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants Who Received Antipyretics - Visit 1
|
21 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 Days Post Visit 2Population: Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Number of children who received antipyretics on day 1 and/or day 2 following Visit 2.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=162 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=155 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants Who Received Antipyretics - Visit 2
|
4 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 7 Days Post Visit 1Population: Modified Intent-to-Treat (mITT) Population: Any participant age 6-23 months with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=127 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=125 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fever · None
|
117 Participants
|
118 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fever · Mild
|
6 Participants
|
6 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fever · Moderate
|
2 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fever · Severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fussiness · None
|
39 Participants
|
37 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fussiness · Mild
|
55 Participants
|
42 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fussiness · Moderate
|
33 Participants
|
44 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Fussiness · Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Change in Eating Habits · None
|
86 Participants
|
82 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Change in Eating Habits · Mild
|
34 Participants
|
33 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Change in Eating Habits · Moderate
|
7 Participants
|
10 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Change in Eating Habits · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Drowsiness · None
|
60 Participants
|
58 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Drowsiness · Mild
|
56 Participants
|
54 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Drowsiness · Moderate
|
11 Participants
|
11 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Drowsiness · Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Vomiting · None
|
108 Participants
|
111 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Vomiting · Mild
|
19 Participants
|
13 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Vomiting · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Diarrhea · None
|
98 Participants
|
105 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Diarrhea · Mild
|
27 Participants
|
18 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Diarrhea · Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old
Diarrhea · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 Days Post Visit 2Population: Modified Intent-to-Treat (mITT) Population: Any participant age 6-23 months enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=123 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=118 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fever · None
|
122 Participants
|
114 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fever · Mild
|
1 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fever · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fever · Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fussiness · None
|
72 Participants
|
43 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fussiness · Mild
|
35 Participants
|
48 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fussiness · Moderate
|
14 Participants
|
25 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Fussiness · Severe
|
2 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Change in Eating Habits · None
|
107 Participants
|
84 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Change in Eating Habits · Mild
|
14 Participants
|
26 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Change in Eating Habits · Moderate
|
2 Participants
|
8 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Change in Eating Habits · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Drowsiness · None
|
102 Participants
|
69 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Drowsiness · Mild
|
19 Participants
|
43 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Drowsiness · Moderate
|
2 Participants
|
6 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Drowsiness · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Vomiting · None
|
110 Participants
|
104 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Vomiting · Mild
|
11 Participants
|
12 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Vomiting · Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Diarrhea · None
|
107 Participants
|
98 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Diarrhea · Mild
|
12 Participants
|
18 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Diarrhea · Moderate
|
3 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old
Diarrhea · Severe
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 Days Post Visit 1Population: Modified Intent-to-Treat (mITT) Population: Any participant age 2-5 years old enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=43 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=40 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fever · None
|
40 Participants
|
38 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fever · Mild
|
2 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fever · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fever · Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fatigue · None
|
30 Participants
|
28 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fatigue · Mild
|
9 Participants
|
7 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fatigue · Moderate
|
4 Participants
|
5 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Fatigue · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Headache · None
|
39 Participants
|
34 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Headache · Mild
|
3 Participants
|
5 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Headache · Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Headache · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Chills · None
|
40 Participants
|
36 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Chills · Mild
|
3 Participants
|
3 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Chills · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Chills · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Vomiting · None
|
40 Participants
|
38 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Vomiting · Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Diarrhea · None
|
31 Participants
|
38 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Diarrhea · Mild
|
12 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Diarrhea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
Diarrhea · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Muscle Pain · None
|
25 Participants
|
30 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Muscle Pain · Mild
|
9 Participants
|
7 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Muscle Pain · Moderate
|
8 Participants
|
3 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Muscle Pain · Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Joint Pain · None
|
40 Participants
|
36 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Joint Pain · Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Joint Pain · Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old
New or Worsened Joint Pain · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 Days Post Visit 2Population: Modified Intent-to-Treat (mITT) Population: Any participant age 2-5 years old enrolled and randomized into the study, and received at least one study vaccine at Visit 1.
Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=39 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=37 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fever · None
|
38 Participants
|
32 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fever · Mild
|
0 Participants
|
3 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fever · Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fever · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fatigue · None
|
33 Participants
|
25 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fatigue · Mild
|
4 Participants
|
7 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fatigue · Moderate
|
2 Participants
|
5 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Fatigue · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Headache · None
|
34 Participants
|
32 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Headache · Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Headache · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Headache · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Chills · None
|
36 Participants
|
34 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Chills · Mild
|
3 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Chills · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Chills · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Vomiting · None
|
36 Participants
|
35 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Vomiting · Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Diarrhea · None
|
34 Participants
|
32 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Diarrhea · Mild
|
5 Participants
|
5 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Diarrhea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
Diarrhea · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Muscle Pain · None
|
38 Participants
|
30 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Muscle Pain · Mild
|
1 Participants
|
5 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Muscle Pain · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Muscle Pain · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Joint Pain · None
|
38 Participants
|
34 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Joint Pain · Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Joint Pain · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old
New or Worsened Joint Pain · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 105 Days Post AdministrationPopulation: Modified Intent-to-Treat (mITT) Population: Any participant enrolled and randomized into the study and received at least one study vaccine at Visit 1.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=174 Participants
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 Participants
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
The Number of Individuals With At Least One Serious Adverse Event
Croup
|
0 Participants
|
1 Participants
|
|
The Number of Individuals With At Least One Serious Adverse Event
Anaphylaxis
|
1 Participants
|
0 Participants
|
|
The Number of Individuals With At Least One Serious Adverse Event
Viral Infection
|
1 Participants
|
0 Participants
|
Adverse Events
Simultaneous Vaccination Arm
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequential Vaccination Arm
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simultaneous Vaccination Arm
n=174 participants at risk
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 participants at risk
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Croup
|
0.00%
0/174 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
0.60%
1/168 • Number of events 1 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
|
Immune system disorders
Anaphylaxis
|
0.57%
1/174 • Number of events 1 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
0.00%
0/168 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
|
General disorders
Viral Infection
|
0.57%
1/174 • Number of events 1 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
0.00%
0/168 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
Other adverse events
| Measure |
Simultaneous Vaccination Arm
n=174 participants at risk
The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
Sequential Vaccination Arm
n=168 participants at risk
The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.
mRNA COVID-19 Vaccine: ACIP Recommended Vaccine
Routine Childhood Vaccinations: ACIP Recommended Vaccines
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/174 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
5.4%
9/168 • Number of events 10 • Adverse events were collected for 7 days after each vaccination visit. Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected through the entire study period (up to 105 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place