Trial Outcomes & Findings for A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients ) (NCT NCT02964910)
NCT ID: NCT02964910
Last Updated: 2019-07-25
Results Overview
Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
475 participants
Primary outcome timeframe
Month 7
Results posted on
2019-07-25
Participant Flow
Participant milestones
| Measure |
the Chronic Hepatitis B Patients
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Overall Study
STARTED
|
235
|
240
|
|
Overall Study
COMPLETED
|
192
|
196
|
|
Overall Study
NOT COMPLETED
|
43
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
the Chronic Hepatitis B Patients
n=235 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
Total
n=475 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 9.7 • n=235 Participants
|
53.4 years
STANDARD_DEVIATION 9.5 • n=240 Participants
|
53.4 years
STANDARD_DEVIATION 9.6 • n=475 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=235 Participants
|
97 Participants
n=240 Participants
|
193 Participants
n=475 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=235 Participants
|
143 Participants
n=240 Participants
|
282 Participants
n=475 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Month 7Population: Totally 192 CHB participants and 196 healthy participants were involved in per-protocol set, who meet the meet the requirements 1) whole-course inoculation, 2)having the results of anti-HEV antibody test before and after immunization, 3) anti-HEV antibody negative before immunization.
Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=192 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=196 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose
|
188 Participants
|
196 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: Totally 192 CHB participants and 196 healthy participants were involved in per-protocol set, who meet the meet the requirements 1) whole-course inoculation, 2)having the results of anti-HEV antibody test before and after immunization, 3) anti-HEV antibody negative before immunization.
Measure the level of anti-HEV antibody in serum samples at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. Wu/ml：World Health Organization (WHO) units per ml. The WHO standard was used to calibrate the antibody quantitative reference.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=192 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=196 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose
|
11.89 Wu/ml
Interval 9.86 to 14.35
|
17.35 Wu/ml
Interval 15.57 to 19.34
|
SECONDARY outcome
Timeframe: Day 0-Month 1Population: All the participants who visited at one month after the first dose.
ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=223 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=220 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
ALT · processed
|
5 Participants
|
4 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
TBIL · no change
|
184 Participants
|
169 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
TBIL · processed
|
12 Participants
|
25 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
TBIL · improved
|
27 Participants
|
26 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
ALT · no change
|
208 Participants
|
215 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
ALT · improved
|
10 Participants
|
1 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
AST · no change
|
186 Participants
|
211 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
AST · processed
|
18 Participants
|
5 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose
AST · improved
|
19 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Month 6-Month 7Population: All the participants who visited at one month after the third dose.
ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=213 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=206 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
AST · processed
|
8 Participants
|
2 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
AST · improved
|
27 Participants
|
1 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
TBIL · no change
|
182 Participants
|
195 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
ALT · no change
|
204 Participants
|
206 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
ALT · processed
|
2 Participants
|
0 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
ALT · improved
|
7 Participants
|
0 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
AST · no change
|
178 Participants
|
203 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
TBIL · processed
|
6 Participants
|
1 Participants
|
|
Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose
TBIL · improved
|
25 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day0-Month 7Population: All the participants who visited at one month after the third dose.
ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: "no change" indicated no grade change; "processed" indicated a change from normal to abnormal or an increase in grade; and "improved" indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=213 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=206 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
ALT · no change
|
199 Participants
|
204 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
ALT · processed
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
ALT · improved
|
13 Participants
|
2 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
AST · no change
|
177 Participants
|
200 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
AST · processed
|
8 Participants
|
2 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
AST · improved
|
28 Participants
|
4 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
TBIL · no change
|
175 Participants
|
162 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
TBIL · processed
|
5 Participants
|
1 Participants
|
|
Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose
TBIL · improved
|
33 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Day 0-Month 7Population: All the participants who received at least one injection.
Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=235 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants Who Experienced Any Adverse Reactions/Events
|
92 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Day 0-Day 7Population: All the participants who received at least one injection.
Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=235 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants Who Experienced Solicited Adverse Reactions/Events
|
42 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Day 0-Day 7Population: All the participants who received at least one injection.
Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=235 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants Who Experienced Solicited Local Adverse Reactions/Events
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 0-Day 7Population: All the participants who received at least one injection.
Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=235 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants Who Experienced Solicited System Adverse Reactions/Events
|
31 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 0-Month 7Population: All the participants who received at least one injection.
Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation.
Outcome measures
| Measure |
the Chronic Hepatitis B Patients
n=235 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 Participants
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Number of Participants Who Experienced Unsolicited Adverse Reactions/Events
|
68 Participants
|
70 Participants
|
Adverse Events
the Chronic Hepatitis B Patients
Serious events: 6 serious events
Other events: 15 other events
Deaths: 1 deaths
the Healthy Volunteer
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
the Chronic Hepatitis B Patients
n=235 participants at risk
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 participants at risk
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
0.43%
1/235 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
0.00%
0/240 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
|
Endocrine disorders
subacute thyroiditis
|
0.43%
1/235 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
0.00%
0/240 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
|
Gastrointestinal disorders
upper gastrointestinal hemorrhage
|
0.43%
1/235 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
0.00%
0/240 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
|
Cardiac disorders
myocardial infarction
|
0.43%
1/235 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
0.00%
0/240 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
|
Nervous system disorders
cerebral infarction
|
0.43%
1/235 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
0.00%
0/240 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
|
Nervous system disorders
VertebrobasilarArtery Insufficiency
|
0.43%
1/235 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
0.42%
1/240 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/235 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
0.42%
1/240 • Number of events 1 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
Other adverse events
| Measure |
the Chronic Hepatitis B Patients
n=235 participants at risk
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
the Healthy Volunteer
n=240 participants at risk
Participants in this arm are aged over 30 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.
Recombinant Hepatitis E Vaccine (Escherichia Coli): Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
|
|---|---|---|
|
General disorders
pyrexia
|
6.4%
15/235 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
7.9%
19/240 • 0-7 months
The definitions of "All-Cause Mortality","Serious Adverse Events" and "Adverse Events" are consistent with the clinicaltrials.gov Definitions. One death was due to myocardial infarction.
|
Additional Information
Shandong Provincial Key Laboratory of Infectious Disease Control and Prevention
Shandong Center for Disease Control and Prevention, Jinan, China
Phone: 0531-82679606
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place