Trial Outcomes & Findings for A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal. (NCT NCT00287469)
NCT ID: NCT00287469
Last Updated: 2019-05-29
Results Overview
Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period. * Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting * Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105) * Percent of Participants = n x 100 / N
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2000 participants
Primary outcome timeframe
14 days after dose 3 at 6 months
Results posted on
2019-05-29
Participant Flow
2000 subject were recruited by Royal Nepalese Army investigators at the Shree Birendra Hospital, Kathmandu from a well characterized population of Royal Nepalese Army military personnel stationed in the Kathmandu Valley and their family members and up to 5 US citizens residing in the Nepal.
Participant milestones
| Measure |
Placebo
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
20mcg Recombinant HEV
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
|---|---|---|
|
Overall Study
STARTED
|
1000
|
1000
|
|
Overall Study
COMPLETED
|
780
|
786
|
|
Overall Study
NOT COMPLETED
|
220
|
214
|
Reasons for withdrawal
| Measure |
Placebo
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
20mcg Recombinant HEV
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
|---|---|---|
|
Overall Study
serious adverse event
|
1
|
6
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
moved from area
|
144
|
138
|
|
Overall Study
Lost to Follow-up
|
74
|
69
|
Baseline Characteristics
Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
Baseline characteristics by cohort
| Measure |
Placebo
n=1000 Participants
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
20mcg Recombinant HEV
n=1000 Participants
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
Total
n=2000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Female
|
31.3 Years
STANDARD_DEVIATION 12.69 • n=4 Participants • Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
|
28.0 Years
STANDARD_DEVIATION 8.29 • n=4 Participants • Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
|
29.6 Years
STANDARD_DEVIATION 10.07 • n=8 Participants • Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
|
|
Age, Continuous
Male
|
25.1 Years
STANDARD_DEVIATION 6.12 • n=996 Participants • Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
|
25.2 Years
STANDARD_DEVIATION 6.34 • n=996 Participants • Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
|
25.2 Years
STANDARD_DEVIATION 6.23 • n=1992 Participants • Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
|
|
Sex: Female, Male
Female
|
4 Participants
n=1000 Participants
|
4 Participants
n=1000 Participants
|
8 Participants
n=2000 Participants
|
|
Sex: Female, Male
Male
|
996 Participants
n=1000 Participants
|
996 Participants
n=1000 Participants
|
1992 Participants
n=2000 Participants
|
|
Region of Enrollment
Nepal
|
1000 participants
n=1000 Participants
|
1000 participants
n=1000 Participants
|
2000 participants
n=2000 Participants
|
PRIMARY outcome
Timeframe: 14 days after dose 3 at 6 monthsPercent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period. * Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting * Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105) * Percent of Participants = n x 100 / N
Outcome measures
| Measure |
20mcg Recombinant HEV
n=1000 Participants
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
Placebo
n=1000 Participants
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
|---|---|---|
|
Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Jaundice; IgM ≥ 100 WR U/mL
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
6.9 Percent of Participants
Interval 5.3 to 8.8
|
|
Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Jaundice; total lg ≥ 2500 WR U/mL
|
0.3 Percent of Participants
Interval 0.1 to 1.0
|
0.1 Percent of Participants
Interval 0.0 to 0.6
|
|
Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
|
0.3 Percent of Participants
Interval 0.1 to 1.0
|
7.0 Percent of Participants
Interval 5.4 to 8.9
|
|
Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Illness; IgM ≥ 100 WR U/mL
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
0.3 Percent of Participants
Interval 0.1 to 1.0
|
|
Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Illness; total lg ≥ 2500 WR U/mL
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
|
Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Illness; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
0.3 Percent of Participants
Interval 0.1 to 1.0
|
|
Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Jaun/Ill; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
|
0.3 Percent of Participants
Interval 0.1 to 1.0
|
7.4 Percent of Participants
Interval 5.7 to 9.3
|
SECONDARY outcome
Timeframe: 14 days after dose 2 until 14 days after dose 3Percent of participants of definite hepatitis E and vaccine efficacy by category during the follow-up period * Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting * Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105) * Percent of participants = n x 100 / N
Outcome measures
| Measure |
20mcg Recombinant HEV
n=1000 Participants
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
Placebo
n=1000 Participants
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
|---|---|---|
|
Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period
Jaundice; IgM ≥ 100 WR U/ml
|
0.1 Percent of Participants
Interval 0.0 to 0.6
|
0.8 Percent of Participants
Interval 0.4 to 1.6
|
|
Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period
Jaundice; total Ig ≥ 2500 WR U/ml
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
|
Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period
Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
|
0.1 Percent of Participants
Interval 0.0 to 0.6
|
0.8 Percent of Participants
Interval 0.4 to 1.6
|
|
Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period
Illness; ImG ≥ 100 WR U/ml
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
|
Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period
Illness; total Ig ≥ 2500 WR U/ml
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
0.0 Percent of Participants
Interval 0.0 to 0.4
|
|
Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period
Jaun/Ill; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
|
0.1 Percent of Participants
Interval 0.0 to 0.6
|
0.8 Percent of Participants
Interval 0.4 to 1.6
|
SECONDARY outcome
Timeframe: before dose 1 thru 14 days after dose 3Number of suspected, definite, probable and not confirmed hepatitis E disease cases during surveillance period
Outcome measures
| Measure |
20mcg Recombinant HEV
n=1000 Participants
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
Placebo
n=1000 Participants
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
|---|---|---|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any acute hep cases: before dose 1
|
0 Number of Hepatitis E Cases
|
1 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any hep cases: within 14 days after dose 1
|
1 Number of Hepatitis E Cases
|
3 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any hep cases: between 14 days after dose 1 and 2
|
5 Number of Hepatitis E Cases
|
2 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any hep cases: within 14 days after dose 2
|
0 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any hep cases: between 14 days after dose 2 and 3
|
7 Number of Hepatitis E Cases
|
4 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any hep cases: within 14 days after dose 3
|
1 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any hep cases: from 14 days after dose 3
|
78 Number of Hepatitis E Cases
|
9 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Any hep cases: Total
|
92 Number of Hepatitis E Cases
|
19 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definite hepE cases: before dose 1
|
0 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definite hepE cases: within 14 days after dose 1
|
1 Number of Hepatitis E Cases
|
3 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definite hepE cases: btwn 14dys after dose 1 and 2
|
3 Number of Hepatitis E Cases
|
2 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definite hepE cases: within 14 days after dose 2
|
0 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definite hepE cases: btwn 14dys after dose 2 and 3
|
7 Number of Hepatitis E Cases
|
1 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definite hepE cases: within 14 days after dose 3
|
1 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definite hepE cases: from 14 days after dose 3
|
66 Number of Hepatitis E Cases
|
3 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Definate hepE cases: Total
|
78 Number of Hepatitis E Cases
|
9 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Probable hepE cases
|
0 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: before dose 1
|
0 Number of Hepatitis E Cases
|
1 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: within 14 days after dose 1
|
0 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: btwn 14dys after dose 1 and 2
|
2 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: within 14 days after dose 2
|
0 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: btwn 14dys after dose 2 and 3
|
0 Number of Hepatitis E Cases
|
3 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: within 14 days after dose 3
|
0 Number of Hepatitis E Cases
|
0 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: from 14 days after dose 3
|
12 Number of Hepatitis E Cases
|
6 Number of Hepatitis E Cases
|
|
Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Not confirmed hepE: total
|
14 Number of Hepatitis E Cases
|
10 Number of Hepatitis E Cases
|
Adverse Events
Placebo
Serious events: 200 serious events
Other events: 226 other events
Deaths: 1 deaths
20mcg Recombinant HEV
Serious events: 143 serious events
Other events: 229 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Placebo
n=1000 participants at risk
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
20mcg Recombinant HEV
n=1000 participants at risk
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
|---|---|---|
|
Psychiatric disorders
Acute stress disorder
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Blindness
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Conjunctivitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Corneal ulcer
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Anal fissure
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Dyspepsia
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Enteritis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Accidental death
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Carcadian rhythm sleep disorder
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Death
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Gravitational oedema
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Pyrexia
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Hepatomegal
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Jaundice
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Jaundice hepatocellular
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Abscess limb
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Acute tonsillitis
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Amoebiasis
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Appendicitis
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Ascariass
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Cestode infection
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Dermatitis infection
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Diarrhoea infectious
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Dysentery
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Encephalitis japanese b
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Gastroenteritis
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Giardiasis
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Hepatitis E
|
8.1%
81/1000 • Number of events 81 • Within 31 days (days 0-30) post-vaccination
|
1.0%
10/1000 • Number of events 10 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Hookworm infection
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Hymenolepiasis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Labyrinthitis
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Leptospirosis
|
1.2%
12/1000 • Number of events 12 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Malaria
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Measles
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Mumps
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Neurocysticercosis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Orchitis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Paratyphoid fever
|
0.70%
7/1000 • Number of events 7 • Within 31 days (days 0-30) post-vaccination
|
0.80%
8/1000 • Number of events 8 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Pneumonia
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Respiratory tuberculosis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Salmonella bacteraemia
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.70%
7/1000 • Number of events 7 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Scrub typhus
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Sexually transmitted disease
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Tonsilitis
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Tuberculous pleurisy
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Typhoid fever
|
2.4%
24/1000 • Number of events 24 • Within 31 days (days 0-30) post-vaccination
|
3.0%
30/1000 • Number of events 30 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Viral infection
|
0.90%
9/1000 • Number of events 9 • Within 31 days (days 0-30) post-vaccination
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Wound infection
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Blast injury
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.90%
9/1000 • Number of events 9 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Head injury
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Polytraumatism
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Investigations
Weight decreased
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Costochandritis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Intervertebrial disc protrution
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Rheumatic fever
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Sacroilitis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Arachnoid cyst
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Convulsion
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Dizziness
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Epilepsy
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Headache
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Psychiatric disorders
Anxiety
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Psychiatric disorders
Anxiety disorder
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Renal and urinary disorders
Calculus bladder
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Reproductive system and breast disorders
Phimosis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Reproductive system and breast disorders
Varicocele
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord thickening
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Social circumstances
Social stay hospitalisation
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Anal fistula excision
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Surgery
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Vascular disorders
Hypertension
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Vascular disorders
Wound haemorrhage
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
Other adverse events
| Measure |
Placebo
n=1000 participants at risk
PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.
Placebo: PBS buffer placebo containing alum
|
20mcg Recombinant HEV
n=1000 participants at risk
20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule
Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Ear and labyrinth disorders
Ear pain
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Astigmatism
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Blepharitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Conjunctivitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Eye disorder
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Eye disorders
Eye pain
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
10/1000 • Number of events 10 • Within 31 days (days 0-30) post-vaccination
|
1.5%
15/1000 • Number of events 15 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
22/1000 • Number of events 22 • Within 31 days (days 0-30) post-vaccination
|
2.2%
22/1000 • Number of events 22 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Dyspepsia
|
0.70%
7/1000 • Number of events 7 • Within 31 days (days 0-30) post-vaccination
|
0.90%
9/1000 • Number of events 9 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Pericoronitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Gastrointestinal disorders
Toothache
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Asthenia
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Chest pain
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Chills
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Fatigue
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Influenza like illness
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Injection site anaesthesia
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Local swelling
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Oedema peripheral
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Pain
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
|
General disorders
Pyrexia
|
3.1%
31/1000 • Number of events 31 • Within 31 days (days 0-30) post-vaccination
|
2.9%
29/1000 • Number of events 29 • Within 31 days (days 0-30) post-vaccination
|
|
Hepatobiliary disorders
Jaundice hepatocellular
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Immune system disorders
Hypersensitivity
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Abscess neck
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Acarodermatitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Acute tonsillitis
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Appendicitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Ascariasis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Diarrhoea infectious
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Dysentery
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Empyema
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Encephalitis japanese b
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Fungal infection
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Furuncle
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Giardiasis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Gingival infection
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Helminthic infection
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Hepatitis e
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Infection
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Influenza
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Labyrinthitis
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Leptospirosis
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Lower respiratory tract infection
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
20/1000 • Number of events 20 • Within 31 days (days 0-30) post-vaccination
|
2.2%
22/1000 • Number of events 22 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Paratyphoid fever
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Pharyngitis
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Respiratory tract infection
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Rhinitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Salmonella bacteraemia
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Scrub typhus
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Sinusitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Subcutaneous abscess
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Tinea pedis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Tonsillitis
|
1.1%
11/1000 • Number of events 11 • Within 31 days (days 0-30) post-vaccination
|
0.80%
8/1000 • Number of events 8 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Typhoid fever
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
0.70%
7/1000 • Number of events 7 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
15/1000 • Number of events 15 • Within 31 days (days 0-30) post-vaccination
|
0.90%
9/1000 • Number of events 9 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Infections and infestations
Viral infection
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Face injury
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Wound
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.50%
5/1000 • Number of events 5 • Within 31 days (days 0-30) post-vaccination
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Metabolism and nutrition disorders
Anorexia
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
0.70%
7/1000 • Number of events 7 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.60%
6/1000 • Number of events 6 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Dizziness
|
1.0%
10/1000 • Number of events 10 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Headache
|
4.3%
43/1000 • Number of events 43 • Within 31 days (days 0-30) post-vaccination
|
3.6%
36/1000 • Number of events 36 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Hypoaesthesia
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Nervous system disorders
Paraesthesia
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Psychiatric disorders
Anxiety
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Psychiatric disorders
Anxiety disorder
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Renal and urinary disorders
Neophrolithiasis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Reproductive system and breast disorders
Varicocele
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.80%
8/1000 • Number of events 8 • Within 31 days (days 0-30) post-vaccination
|
0.80%
8/1000 • Number of events 8 • Within 31 days (days 0-30) post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.40%
4/1000 • Number of events 4 • Within 31 days (days 0-30) post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.30%
3/1000 • Number of events 3 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Tooth extraction
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.20%
2/1000 • Number of events 2 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Vasectomy
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
|
Surgical and medical procedures
Wart excision
|
0.10%
1/1000 • Number of events 1 • Within 31 days (days 0-30) post-vaccination
|
0.00%
0/1000 • Within 31 days (days 0-30) post-vaccination
|
Additional Information
Mrigendra P. Shrestha MD
Armed Forces Research Institute of Medical Services
Phone: 662-644-4888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place