Trial Outcomes & Findings for Prevenar (PCV-7) Post-Licensure Safety Study In Russia (NCT NCT01207583)
NCT ID: NCT01207583
Last Updated: 2012-08-31
Results Overview
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (\>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of \>=38 degrees C to less than or equal to (\<=) 39 degrees C, \>39 degrees C to \<=40 degrees C and \>40 degrees C were observed.
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
Day 1 to Day 3 post-dose 1
Results posted on
2012-08-31
Participant Flow
Participant milestones
| Measure |
Primary Cohort (3-6 Months)
Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC).
|
Catch-up Cohort (7-11 Months)
Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
31
|
55
|
|
Overall Study
Dose 1
|
14
|
31
|
55
|
|
Overall Study
Dose 2
|
13
|
29
|
54
|
|
Overall Study
Dose 3
|
13
|
27
|
0
|
|
Overall Study
Dose 4
|
7
|
0
|
0
|
|
Overall Study
COMPLETED
|
13
|
26
|
54
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
1
|
Reasons for withdrawal
| Measure |
Primary Cohort (3-6 Months)
Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC).
|
Catch-up Cohort (7-11 Months)
Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
|
Overall Study
Participant failed to return
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
Baseline Characteristics
Prevenar (PCV-7) Post-Licensure Safety Study In Russia
Baseline characteristics by cohort
| Measure |
Primary Cohort (3-6 Months)
n=14 Participants
Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=31 Participants
Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
n=55 Participants
Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
3 to 6 months
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Customized
7 to 11 months
|
0 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Customized
12 to 23 months
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 3 post-dose 1Population: Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (\>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of \>=38 degrees C to less than or equal to (\<=) 39 degrees C, \>39 degrees C to \<=40 degrees C and \>40 degrees C were observed.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=14 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=31 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
n=55 Participants
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Febrile Reactions Post-dose 1
38 to 39 degrees C
|
14.3 Percentage of participants
Interval 4.0 to 39.9
|
16.1 Percentage of participants
Interval 7.1 to 32.6
|
1.8 Percentage of participants
Interval 0.3 to 9.6
|
|
Percentage of Participants With Febrile Reactions Post-dose 1
>39 to 40 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 21.5
|
3.2 Percentage of participants
Interval 0.6 to 16.2
|
3.6 Percentage of participants
Interval 1.0 to 12.3
|
PRIMARY outcome
Timeframe: Day 1 to Day 3 post-dose 2Population: Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C to \<=39 degrees C was observed.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=13 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=29 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
n=54 Participants
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Febrile Reactions Post-dose 2
|
23.1 Percentage of participants
Interval 8.2 to 50.3
|
10.3 Percentage of participants
Interval 3.6 to 26.4
|
0.0 Percentage of participants
Interval 0.0 to 6.6
|
PRIMARY outcome
Timeframe: Day 1 to Day 3 post-dose 3Population: Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C to \<=39 degrees C was observed.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=13 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=26 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Febrile Reactions Post-dose 3
|
15.4 Percentage of participants
Interval 4.3 to 42.2
|
0.0 Percentage of participants
Interval 0.0 to 12.9
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 3 post-dose 4Population: Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C was observed.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=7 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Febrile Reactions Post-dose 4
|
0.0 Percentage of participants
Interval 0.0 to 35.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 1Population: Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 centimeters \[cm\]); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=14 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=31 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
n=55 Participants
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Injection site warmth
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Redness
|
7.1 Percentage of participants
|
19.4 Percentage of participants
|
27.3 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Swelling
|
0.0 Percentage of participants
|
6.5 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Tenderness
|
7.1 Percentage of participants
|
29.0 Percentage of participants
|
23.6 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Injection site hematoma
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Injection site hemorrhage
|
0.0 Percentage of participants
|
3.2 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Injection site induration
|
7.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 2Population: Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=13 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=29 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
n=54 Participants
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Tenderness
|
0.0 Percentage of participants
|
6.9 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Injection site hemorrhage
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Injection site induration
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Swelling
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Redness
|
23.1 Percentage of participants
|
13.8 Percentage of participants
|
20.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 3Population: Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=13 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=26 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Tenderness
|
7.7 Percentage of participants
|
7.7 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Redness
|
15.4 Percentage of participants
|
3.8 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Swelling
|
7.7 Percentage of participants
|
3.8 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Injection site induration
|
7.7 Percentage of participants
|
0.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 4Population: Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=7 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Redness
|
14.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Swelling
|
14.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Injection site induration
|
14.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 1Population: Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=14 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=31 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
n=55 Participants
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Decreased appetite
|
7.1 Percentage of participants
|
19.4 Percentage of participants
|
23.6 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Diarrhea
|
7.1 Percentage of participants
|
3.2 Percentage of participants
|
9.1 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Fever
|
14.3 Percentage of participants
|
19.4 Percentage of participants
|
5.5 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Restless sleep
|
7.1 Percentage of participants
|
32.3 Percentage of participants
|
27.3 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Unusual crying
|
14.3 Percentage of participants
|
25.8 Percentage of participants
|
30.9 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Unusual fussiness
|
7.1 Percentage of participants
|
6.5 Percentage of participants
|
12.7 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Unusual irritability
|
21.4 Percentage of participants
|
19.4 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Vomiting
|
0.0 Percentage of participants
|
6.5 Percentage of participants
|
3.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 2Population: Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=13 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=29 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
n=54 Participants
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Decreased appetite
|
15.4 Percentage of participants
|
10.3 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Diarrhea
|
15.4 Percentage of participants
|
3.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Unusual fussiness
|
15.4 Percentage of participants
|
6.9 Percentage of participants
|
7.4 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Unusual irritability
|
23.1 Percentage of participants
|
6.9 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Vomiting
|
7.7 Percentage of participants
|
0.0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Fever
|
23.1 Percentage of participants
|
10.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Restless sleep
|
23.1 Percentage of participants
|
24.1 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Unusual crying
|
23.1 Percentage of participants
|
20.7 Percentage of participants
|
13.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 3Population: Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=13 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
n=26 Participants
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Vomiting
|
15.4 Percentage of participants
|
3.8 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Decreased appetite
|
7.7 Percentage of participants
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Diarrhea
|
15.4 Percentage of participants
|
3.8 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Fever
|
15.4 Percentage of participants
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Restless sleep
|
46.2 Percentage of participants
|
11.5 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Unusual crying
|
15.4 Percentage of participants
|
11.5 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Unusual fussiness
|
15.4 Percentage of participants
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Unusual irritability
|
7.7 Percentage of participants
|
7.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 3 post-dose 4Population: Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
Primary Cohort (3-6 Months)
n=7 Participants
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (7-11 Months)
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Catch-up Cohort (12-23 Months)
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Restless sleep
|
28.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Unusual crying
|
14.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Unusual irritability
|
14.3 Percentage of participants
|
—
|
—
|
Adverse Events
Dose 1 (Primary Cohort [3-6 Months])
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose 2 (Primary Cohort [3-6 Months])
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose 3 (Primary Cohort [3-6 Months])
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose 4 (Primary Cohort [3-6 Months])
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose 1 (Catch-up Cohort [7-11 Months])
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Dose 2 (Catch-up Cohort [7-11 Months])
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Dose 3 (Catch-up Cohort [7-11 Months])
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose 1 (Catch-up Cohort [12-23 Months])
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Dose 2 (Catch-up Cohort [12-23 Months])
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose 1 (Primary Cohort [3-6 Months])
n=14 participants at risk
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 2 (Primary Cohort [3-6 Months])
n=13 participants at risk
Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 3 (Primary Cohort [3-6 Months])
n=13 participants at risk
Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 4 (Primary Cohort [3-6 Months])
n=7 participants at risk
Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 1 (Catch-up Cohort [7-11 Months])
n=31 participants at risk
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 2 (Catch-up Cohort [7-11 Months])
n=29 participants at risk
Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 3 (Catch-up Cohort [7-11 Months])
n=26 participants at risk
Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 1 (Catch-up Cohort [12-23 Months])
n=55 participants at risk
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 2 (Catch-up Cohort [12-23 Months])
n=54 participants at risk
Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
1/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Dose 1 (Primary Cohort [3-6 Months])
n=14 participants at risk
Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 2 (Primary Cohort [3-6 Months])
n=13 participants at risk
Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 3 (Primary Cohort [3-6 Months])
n=13 participants at risk
Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 4 (Primary Cohort [3-6 Months])
n=7 participants at risk
Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 1 (Catch-up Cohort [7-11 Months])
n=31 participants at risk
Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 2 (Catch-up Cohort [7-11 Months])
n=29 participants at risk
Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 3 (Catch-up Cohort [7-11 Months])
n=26 participants at risk
Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 1 (Catch-up Cohort [12-23 Months])
n=55 participants at risk
Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
|
Dose 2 (Catch-up Cohort [12-23 Months])
n=54 participants at risk
Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Disbacteriosis
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.4%
1/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site induration
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
2/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.5%
2/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.5%
2/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.9%
2/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Body temperature increased
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
1/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Crying
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
1/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.6%
2/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Redness
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
19.4%
6/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.8%
4/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
27.3%
15/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.4%
11/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.5%
2/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.5%
14/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
6/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
29.0%
9/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.9%
2/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
2/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.6%
13/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
9/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site haematoma
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
1/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site warmth
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.8%
1/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Decreased appetite
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
19.4%
6/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
3/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.6%
13/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.3%
5/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Diarrhea
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
1/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.4%
1/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.1%
5/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fever
|
14.3%
2/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
19.4%
6/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
3/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.5%
3/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Restless sleep
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
46.2%
6/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
32.3%
10/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
24.1%
7/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.5%
3/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
27.3%
15/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
9/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Unusual crying
|
14.3%
2/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.8%
8/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.7%
6/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.5%
3/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
30.9%
17/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.0%
7/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Unusual fussiness
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.5%
2/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.9%
2/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.7%
7/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.4%
4/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Unusual irritability
|
21.4%
3/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.1%
3/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
19.4%
6/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.9%
2/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
2/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.5%
14/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.3%
5/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vomiting
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.5%
2/31
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/29
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
1/26
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.6%
2/55
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER