Trial Outcomes & Findings for A Sourcing Study to Collect Human Blood Samples From Healthy Adults (NCT NCT03493919)
NCT ID: NCT03493919
Last Updated: 2023-07-17
Results Overview
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day -83, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.
COMPLETED
PHASE4
1021 participants
At Day -83 [83 days before first vaccination (Day 1)]
2023-07-17
Participant Flow
To comply with the local health authorities and guidelines \[Australian Red Cross, 2016\] with a minimum 90-day interval between blood draws, 3 MenACWY groups were formed to ensure blood draw at Days -83 \[83 days before first vaccination (Day 1)\], -60 \[60 days before first vaccination (Day 1), -30 \[30 days before first vaccination (Day 1), 31, 61, and 151. The rMenB+OMV NZ group was not split due to sufficient intervals between the post-vaccination blood sampling time points (Day 8 and Day 98).
Out of 1021 participants enrolled, 60 participants did not receive vaccination as they did not meet the eligibility criteria or withdrew from the study, therefore only 961 participants were included in the Exposed Set and started the study.
Participant milestones
| Measure |
rMenB+OMV NZ Group
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 2 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
470
|
165
|
165
|
161
|
|
Overall Study
COMPLETED
|
454
|
161
|
163
|
157
|
|
Overall Study
NOT COMPLETED
|
16
|
4
|
2
|
4
|
Reasons for withdrawal
| Measure |
rMenB+OMV NZ Group
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 2 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Overall Study
Other
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
0
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
Baseline characteristics by cohort
| Measure |
rMenB+OMV NZ Group
n=470 Participants
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
n=165 Participants
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 2 Group
n=165 Participants
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.
|
MenACWY 3 Group
n=161 Participants
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
Total
n=961 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.8 YEARS
STANDARD_DEVIATION 8.8 • n=5 Participants
|
33.3 YEARS
STANDARD_DEVIATION 9.1 • n=7 Participants
|
33.3 YEARS
STANDARD_DEVIATION 9.0 • n=5 Participants
|
32.9 YEARS
STANDARD_DEVIATION 8.8 • n=4 Participants
|
33.0 YEARS
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
295 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
608 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
353 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
430 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
876 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day -83 [83 days before first vaccination (Day 1)]Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day -83, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=5578 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
n=1936 Samples
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
|
5578 Blood samples
|
1936 Blood samples
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 8Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 8, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=5396 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
n=1907 Samples
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day 8
|
5396 Blood samples
|
1907 Blood samples
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 98Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 98, blood samples were collected only for rMenB+OMV NZ group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=5204 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day 98
|
5204 Blood samples
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 151Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 151, blood samples were collected only for MenACWY 1, 2 and 3 group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=1869 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
n=1866 Samples
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
n=1752 Samples
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day 151
|
1869 Blood samples
|
1866 Blood samples
|
1752 Blood samples
|
—
|
PRIMARY outcome
Timeframe: At Day -60 [60 days before first vaccination (Day 1)]Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day -60, blood samples were collected only for MenACWY 2 group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=1957 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day -60
|
1957 Blood samples
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 31Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 31, blood samples were collected only for MenACWY 2 group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=1920 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day 31
|
1920 Blood samples
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day -30 [30 days before first vaccination (Day 1)]Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day -30, blood samples were collected only for MenACWY 3 group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=1894 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day-30
|
1894 Blood samples
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 61Population: Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints.
The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines \[Australian Red Cross, 2016\], blood samples were collected with the minimum interval of approximately 90 days. For Day 61, blood samples were collected only for MenACWY 3 group.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=1809 Samples
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Human Blood Samples Collected for Conversion Into Serum at Day 61
|
1809 Blood samples
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout the study period (approximately 4 years)Population: Analysis was performed on blood samples collected from exposed set, which included all participants subjects in the exposed set who provide safety data.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity in a subject or is a congenital anomaly/ birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician. Related=AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
rMenB+OMV NZ Group
n=470 Participants
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
n=165 Participants
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 3 Group
n=165 Participants
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
MenACWY 3 Group
n=161 Participants
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
rMenB+OMV NZ Group
MenACWY 1 Group
MenACWY 2 Group
MenACWY 3 Group
Serious adverse events
| Measure |
rMenB+OMV NZ Group
n=470 participants at risk
Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.
|
MenACWY 1 Group
n=165 participants at risk
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
|
MenACWY 2 Group
n=165 participants at risk
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.
|
MenACWY 3 Group
n=161 participants at risk
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/470 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.61%
1/165 • Number of events 1 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/161 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.21%
1/470 • Number of events 1 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/161 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/470 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.61%
1/165 • Number of events 1 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/161 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
|
Psychiatric disorders
Depression
|
0.21%
1/470 • Number of events 1 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/161 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.21%
1/470 • Number of events 1 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/165 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
0.00%
0/161 • Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER