Trial Outcomes & Findings for Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine (NCT NCT01567865)
NCT ID: NCT01567865
Last Updated: 2018-12-05
Results Overview
Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT \[Hombach et al. 2005\]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
818 participants
Primary outcome timeframe
28 days post-vaccination
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Reference Lot
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
|---|---|---|---|---|
|
Enrolled and Vaccinated (Day 0)
STARTED
|
163
|
220
|
211
|
224
|
|
Enrolled and Vaccinated (Day 0)
COMPLETED
|
163
|
220
|
211
|
224
|
|
Enrolled and Vaccinated (Day 0)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Evaluated for Immunogenicity
STARTED
|
163
|
220
|
211
|
224
|
|
Evaluated for Immunogenicity
COMPLETED
|
146
|
195
|
192
|
194
|
|
Evaluated for Immunogenicity
NOT COMPLETED
|
17
|
25
|
19
|
30
|
Reasons for withdrawal
| Measure |
Reference Lot
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
|---|---|---|---|---|
|
Evaluated for Immunogenicity
Sero+ for anti-JEV at Visit 1
|
0
|
1
|
3
|
2
|
|
Evaluated for Immunogenicity
Missing blood sample
|
17
|
24
|
16
|
28
|
Baseline Characteristics
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
Baseline characteristics by cohort
| Measure |
Reference Lot
n=146 Participants
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=195 Participants
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=192 Participants
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=194 Participants
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
Total
n=727 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.8 months
STANDARD_DEVIATION .68 • n=5 Participants
|
10.9 months
STANDARD_DEVIATION .73 • n=7 Participants
|
10.8 months
STANDARD_DEVIATION .65 • n=5 Participants
|
10.9 months
STANDARD_DEVIATION .7 • n=4 Participants
|
10.9 months
STANDARD_DEVIATION .7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
366 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
361 Participants
n=21 Participants
|
|
Region of Enrollment
Bangladesh
|
146 participants
n=5 Participants
|
195 participants
n=7 Participants
|
192 participants
n=5 Participants
|
194 participants
n=4 Participants
|
727 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: Per protocol population
Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT \[Hombach et al. 2005\]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.
Outcome measures
| Measure |
Reference Lot
n=146 Participants
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=195 Participants
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=192 Participants
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=194 Participants
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
All New Lots
n=581 Participants
All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
|
|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Demonstrated Seroprotection
Seroprotection
|
126 Participants
|
160 Participants
|
154 Participants
|
164 Participants
|
478 Participants
|
|
Number/Percentage of Subjects With Demonstrated Seroprotection
No seroprotection
|
20 Participants
|
35 Participants
|
38 Participants
|
30 Participants
|
103 Participants
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: Per-Protocol Population
Geometric Mean Titers of Neutralizing anti-JEV antibody
Outcome measures
| Measure |
Reference Lot
n=146 Participants
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=195 Participants
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=192 Participants
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=194 Participants
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
All New Lots
n=581 Participants
All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT)
|
77.3 titer
Interval 59.6 to 100.4
|
52.8 titer
Interval 42.9 to 65.1
|
53.4 titer
Interval 42.4 to 67.2
|
62.8 titer
Interval 50.3 to 78.4
|
56.2 titer
Interval 49.5 to 63.8
|
SECONDARY outcome
Timeframe: Within 30 minutes of vaccinationPopulation: All study subjects receiving vaccine were included in this measure.
Subjects were monitored for the following adverse events and categorized as events almost certainly related to receipt of the vaccine: Redness Swelling Tenderness Dyspnea Cyanosis Loose Stools Vomiting Convulsion Fever (37 degrees Celsius or greater, axillary) Hives (urticaria) Angioedema
Outcome measures
| Measure |
Reference Lot
n=163 Participants
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=220 Participants
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=211 Participants
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=224 Participants
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
All New Lots
All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
|
|---|---|---|---|---|---|
|
Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)
Any immediate RE
|
0 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
—
|
|
Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)
No immediate RE
|
163 Participants
|
214 Participants
|
206 Participants
|
222 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 7 days of vaccinationPopulation: All subjects receiving the vaccine were assessed for this measure.
Collected by a home visit to observe the subject and interview his/her parent or guardian occurrence and severity of solicited injection site reactogenicity events (REs) related to vaccination and solicited systemic REs or other AEs that might or might not be related to the prior receipt of vaccine
Outcome measures
| Measure |
Reference Lot
n=163 Participants
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=220 Participants
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=211 Participants
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=224 Participants
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
All New Lots
All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
|
|---|---|---|---|---|---|
|
Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination
Any RE
|
51 Participants
|
75 Participants
|
81 Participants
|
61 Participants
|
—
|
|
Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination
No RE
|
112 Participants
|
145 Participants
|
130 Participants
|
163 Participants
|
—
|
SECONDARY outcome
Timeframe: Between 7 and 28 days of vaccinationPopulation: All subjects receiving the vaccine were evaluated for this measure.
Adverse events other than solicited reactogenicities were obtained through review of medical history when subject returned to clinic. They were graded for severity and rated by the PI for possible relationship to vaccination throughout the 28 days study period.
Outcome measures
| Measure |
Reference Lot
n=163 Participants
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=220 Participants
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=211 Participants
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=224 Participants
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
All New Lots
All subjects receiving vaccine from the new facility (Lot 1, 2, or 3)
|
|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Other Adverse Events (AE) During the Study
Any AE
|
60 Participants
|
84 Participants
|
92 Participants
|
77 Participants
|
—
|
|
Number/Percentage of Subjects With Other Adverse Events (AE) During the Study
No AE
|
103 Participants
|
136 Participants
|
119 Participants
|
147 Participants
|
—
|
Adverse Events
Reference Lot
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
New Lot #1
Serious events: 4 serious events
Other events: 84 other events
Deaths: 0 deaths
New Lot #2
Serious events: 4 serious events
Other events: 92 other events
Deaths: 0 deaths
New Lot #3
Serious events: 0 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reference Lot
n=163 participants at risk
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=220 participants at risk
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=211 participants at risk
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=224 participants at risk
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Severe pneumonia
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.4%
3/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Dysentery
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Acute watery diarrhea
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.4%
3/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.47%
1/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
Other adverse events
| Measure |
Reference Lot
n=163 participants at risk
Lot of Vaccine produced in existing facility
Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #1
n=220 participants at risk
First lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #2
n=211 participants at risk
Second lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
New Lot #3
n=224 participants at risk
Third lot of vaccine produced in new facility
Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.47%
1/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
13/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
6.8%
15/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
10.0%
21/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
3.6%
8/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
8/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
6.8%
15/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
8.1%
17/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
4.0%
9/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Injection site erythema
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.47%
1/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
General disorders
Injection site inflammation
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Gastrointestinal disorders
Injection site pain
|
3.1%
5/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.8%
4/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.4%
3/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.2%
5/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
General disorders
Injection site swelling
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.95%
2/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
General disorders
Irritability
|
4.3%
7/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
4.1%
9/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
3.8%
8/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.7%
6/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
General disorders
Pain
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.9%
4/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.2%
5/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
General disorders
Pyrexia
|
24.5%
40/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
25.5%
56/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
28.9%
61/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
23.7%
53/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
General disorders
Swelling
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.95%
2/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
General disorders
Tenderness
|
4.3%
7/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.3%
5/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.8%
6/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
4.5%
10/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Infections and infestations
Abscess
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Infections and infestations
Furuncle
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.47%
1/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
3/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
3.6%
8/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.4%
3/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.8%
4/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.1%
36/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
12.3%
27/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
14.7%
31/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
13.8%
31/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.47%
1/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Nervous system disorders
Crying
|
8.0%
13/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
5.0%
11/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
5.7%
12/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
4.9%
11/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Nervous system disorders
Somnolence
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.8%
4/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.47%
1/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.89%
2/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Psychiatric disorders
Insomnia
|
5.5%
9/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.7%
6/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
5.2%
11/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.2%
5/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
5/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
8.2%
18/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
9.0%
19/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
6.2%
14/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.8%
3/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
3.6%
8/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.4%
3/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
1.8%
4/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorhhea
|
1.2%
2/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.3%
5/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.4%
5/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
2.2%
5/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.95%
2/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.47%
1/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritis generalized
|
0.00%
0/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.45%
1/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.61%
1/163 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/220 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/211 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
0.00%
0/224 • 28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place