Trial Outcomes & Findings for Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine (NCT NCT00249769)
NCT ID: NCT00249769
Last Updated: 2020-03-10
Results Overview
Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
LJEV Then MV
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Overall Study
COMPLETED
|
98
|
235
|
222
|
|
Overall Study
NOT COMPLETED
|
2
|
15
|
28
|
|
Overall Study
Received Measles Vaccine
|
97
|
236
|
235
|
|
Overall Study
STARTED
|
100
|
250
|
250
|
|
Overall Study
Received LJEV
|
100
|
236
|
224
|
Reasons for withdrawal
| Measure |
LJEV Then MV
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
10
|
6
|
|
Overall Study
Migration from Study Area
|
1
|
3
|
14
|
|
Overall Study
Miscellaneous
|
0
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
Baseline Characteristics
Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Baseline characteristics by cohort
| Measure |
LJEV Then MV
n=100 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=236 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=235 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
Total
n=571 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.9 months
STANDARD_DEVIATION 0.3 • n=99 Participants
|
8.9 months
STANDARD_DEVIATION 0.3 • n=107 Participants
|
8.9 months
STANDARD_DEVIATION 0.3 • n=206 Participants
|
8.7 months
STANDARD_DEVIATION 0.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
284 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
287 Participants
n=7 Participants
|
|
Weight
|
7.9 kilograms
STANDARD_DEVIATION 1.0 • n=99 Participants
|
8.0 kilograms
STANDARD_DEVIATION 1.0 • n=107 Participants
|
8.1 kilograms
STANDARD_DEVIATION 1.0 • n=206 Participants
|
8.0 kilograms
STANDARD_DEVIATION 1.0 • n=7 Participants
|
|
Height
|
66.3 centimeters
STANDARD_DEVIATION 2.6 • n=99 Participants
|
67.6 centimeters
STANDARD_DEVIATION 2.7 • n=107 Participants
|
67.7 centimeters
STANDARD_DEVIATION 2.6 • n=206 Participants
|
67.4 centimeters
STANDARD_DEVIATION 2.7 • n=7 Participants
|
PRIMARY outcome
Timeframe: Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)Population: The per-protocol population includes randomized participants who received at least one vaccine dose excluding participants who did not meet the inclusion/exclusion criteria or were found non-compliant to the immunization or blood sampling schedule. The analysis includes participants with valid serology results for measles antibody during retesting.
Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.
Outcome measures
| Measure |
LJEV Then MV
n=88 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=219 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=178 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination
Day 0
|
1.1 percentage of participants
Interval 0.0 to 6.2
|
0.0 percentage of participants
Interval 0.0 to 1.7
|
0.0 percentage of participants
Interval 0.0 to 2.1
|
|
Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination
Day 28
|
88.6 percentage of participants
Interval 80.1 to 94.4
|
91.8 percentage of participants
Interval 87.3 to 95.1
|
86.5 percentage of participants
Interval 80.6 to 91.2
|
SECONDARY outcome
Timeframe: Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)Population: Per protocol population
Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
LJEV Then MV
n=88 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=222 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=180 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination
Day 0
|
3.4 percentage of participants
Interval 0.7 to 9.6
|
5.4 percentage of participants
Interval 2.8 to 9.3
|
6.1 percentage of participants
Interval 3.1 to 10.7
|
|
Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination
Day 28
|
92.1 percentage of participants
Interval 84.3 to 96.7
|
90.5 percentage of participants
Interval 85.9 to 94.1
|
90.6 percentage of participants
Interval 85.3 to 94.4
|
SECONDARY outcome
Timeframe: Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)Population: Per-protocol population; the analysis includes participants with valid serology results for measles antibody during retesting.
Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.
Outcome measures
| Measure |
LJEV Then MV
n=88 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=219 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=178 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination
Day 0
|
12.8 mIU/mL
Interval 10.2 to 16.2
|
7.4 mIU/mL
Interval 6.3 to 8.8
|
7.0 mIU/mL
Interval 5.8 to 8.5
|
|
Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination
Day 28
|
318.9 mIU/mL
Interval 273.0 to 372.6
|
301.9 mIU/mL
Interval 269.0 to 338.9
|
262.5 mIU/mL
Interval 222.2 to 310.2
|
SECONDARY outcome
Timeframe: Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)Population: Per-protocol population
Assayed by plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
LJEV Then MV
n=88 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=219 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=178 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination
Day 0
|
5.7 titer
Interval 4.9 to 6.5
|
5.7 titer
Interval 5.2 to 6.1
|
5.9 titer
Interval 5.3 to 6.6
|
|
Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination
Day 28
|
202.8 titer
Interval 140.5 to 292.9
|
155.0 titer
Interval 123.5 to 194.5
|
139.4 titer
Interval 109.5 to 177.5
|
SECONDARY outcome
Timeframe: Up to 7 days after LJEV administrationPopulation: Participants who received LJEV
Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.
Outcome measures
| Measure |
LJEV Then MV
n=100 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=236 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=224 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Local reactions: moderate
|
8 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Local reactions: severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Systemic reactions: any
|
58 Participants
|
97 Participants
|
88 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Systemic reaction: mild
|
34 Participants
|
53 Participants
|
56 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Systemic reaction: moderate
|
22 Participants
|
37 Participants
|
30 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Systemic reaction: severe
|
2 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Local reactions: any
|
27 Participants
|
53 Participants
|
27 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Local reactions: mild
|
19 Participants
|
48 Participants
|
22 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Fever: any
|
24 Participants
|
52 Participants
|
57 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Fever: 37.5-38.6°C
|
18 Participants
|
38 Participants
|
47 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Fever: 38.7-39.9°C
|
6 Participants
|
14 Participants
|
10 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Fever: ≥ 40°C
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days after measles vaccinationPopulation: Participants who received measles vaccine
Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.
Outcome measures
| Measure |
LJEV Then MV
n=97 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=236 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=235 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Local reactions: moderate
|
4 Participants
|
2 Participants
|
11 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Systemic reaction: moderate
|
13 Participants
|
37 Participants
|
42 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Fever: any
|
31 Participants
|
52 Participants
|
64 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Local reactions: any
|
19 Participants
|
44 Participants
|
61 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Local reactions: mild
|
15 Participants
|
42 Participants
|
50 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Local reactions: severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Systemic reactions: any
|
49 Participants
|
97 Participants
|
122 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Systemic reaction: mild
|
31 Participants
|
53 Participants
|
77 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Systemic reaction: severe
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Fever: 37.5-38.6°C
|
21 Participants
|
38 Participants
|
52 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Fever: 38.7-39.9°C
|
10 Participants
|
14 Participants
|
12 Participants
|
|
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Fever: ≥ 40°C
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days post-vaccinationPopulation: Safety population
Outcome measures
| Measure |
LJEV Then MV
n=100 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=236 Participants
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=235 Participants
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Number of Participants Experiencing Unsolicited Adverse Events (AE)
Any Adverse Event
|
35 Participants
|
43 Participants
|
79 Participants
|
|
Number of Participants Experiencing Unsolicited Adverse Events (AE)
Related adverse event
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Experiencing Unsolicited Adverse Events (AE)
Serious adverse event
|
2 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
LJEV Then MV
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
LJEV and MV
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
MV Then LJEV
Serious events: 7 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LJEV Then MV
n=100 participants at risk
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=236 participants at risk
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=235 participants at risk
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Gastrointestinal disorders
Amoebiasis
|
1.0%
1/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.85%
2/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Renal and urinary disorders
Urinary tract infection
|
1.0%
1/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Gastrointestinal disorders
Acute Gastroenteritis
|
2.0%
2/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Asthma
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Nervous system disorders
Complex Febrile Seizure
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Pneumonia
|
1.0%
1/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
Other adverse events
| Measure |
LJEV Then MV
n=100 participants at risk
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
|
LJEV and MV
n=236 participants at risk
Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
|
MV Then LJEV
n=235 participants at risk
Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
|
|---|---|---|---|
|
Infections and infestations
Acute bronchitis
|
4.0%
4/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
2.1%
5/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
8.0%
8/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
3.0%
7/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
3.4%
8/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Acute otitis media
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Acute rhinitis
|
6.0%
6/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
2.5%
6/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
4.3%
10/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Acute Tonsillopharyngitis
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Skin and subcutaneous tissue disorders
Atopic dermatitis
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Bacterial conjunctivitis
|
1.0%
1/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Immune system disorders
Bronchial asthma
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.85%
2/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Cellulitis
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
1.3%
3/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Enteric fever
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Skin and subcutaneous tissue disorders
Impetigo contagious
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Injury, poisoning and procedural complications
Infected wound
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Injury, poisoning and procedural complications
Insect bite
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Gastrointestinal disorders
Intestinal parasitism
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Skin and subcutaneous tissue disorders
Maculo-papular lesions
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.85%
2/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Gastrointestinal disorders
Oral candidiasis
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Pneumonia
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.85%
2/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Surgical and medical procedures
Post-extraction hematoma
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.85%
2/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Surgical and medical procedures
Post-vaccination reaction
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Roseola infantum
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Gastrointestinal disorders
Stomatitis
|
1.0%
1/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Systemic viral infection
|
4.0%
4/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.85%
2/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
14.0%
14/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
7.6%
18/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
17.9%
42/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Eye disorders
Viral conjunctivitis
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.42%
1/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.00%
0/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
1.3%
3/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.00%
0/236 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
0.43%
1/235 • 1 month for serious adverse events and 7 days for non-serious adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place