Trial Outcomes & Findings for A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years (NCT NCT01352793)
NCT ID: NCT01352793
Last Updated: 2015-03-11
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5715 participants
Primary outcome timeframe
Vaccination 1 up to 6 months after Vaccination 3
Results posted on
2015-03-11
Participant Flow
A total of 5712 participants in 12 countries were enrolled in this study. Of these, 8 participants were randomized but did not receive study vaccination.
Participant milestones
| Measure |
Group 1: rLP2086
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Overall Study
STARTED
|
3804
|
1908
|
|
Overall Study
Vaccination 1
|
3796
|
1908
|
|
Overall Study
Vaccination 2
|
3530
|
1806
|
|
Overall Study
Vaccination 3
|
3314
|
1710
|
|
Overall Study
COMPLETED
|
3219
|
1663
|
|
Overall Study
NOT COMPLETED
|
585
|
245
|
Reasons for withdrawal
| Measure |
Group 1: rLP2086
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
289
|
125
|
|
Overall Study
Withdrawal by Subject
|
120
|
55
|
|
Overall Study
Protocol Violation
|
44
|
23
|
|
Overall Study
Adverse Event
|
44
|
10
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Pregnancy
|
26
|
8
|
|
Overall Study
Other
|
25
|
7
|
|
Overall Study
Medication error
|
2
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Randomized but not vaccinated
|
8
|
0
|
|
Overall Study
No longer meets eligibility criteria
|
25
|
15
|
Baseline Characteristics
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Baseline characteristics by cohort
| Measure |
Group 1: rLP2086
n=3804 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
Total
n=5712 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
17.4 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
17.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1962 Participants
n=5 Participants
|
994 Participants
n=7 Participants
|
2956 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1842 Participants
n=5 Participants
|
914 Participants
n=7 Participants
|
2756 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Vaccination 1 up to 6 months after Vaccination 3Population: Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
|
1.55 percentage of participants
Interval 1.2 to 2.0
|
2.52 percentage of participants
Interval 1.9 to 3.3
|
PRIMARY outcome
Timeframe: Within 30 days after Vaccination 1Population: Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.
A medically attended AE was defined as a non-serious AE that required medical attention.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
|
7.03 percentage of participants
Interval 6.2 to 7.9
|
6.13 percentage of participants
Interval 5.1 to 7.3
|
PRIMARY outcome
Timeframe: Within 30 days after Vaccination 2Population: Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.
A medically attended AE was defined as a non-serious AE that required medical attention.
Outcome measures
| Measure |
Group 1: rLP2086
n=3529 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1806 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
|
5.50 percentage of participants
Interval 4.8 to 6.3
|
6.09 percentage of participants
Interval 5.0 to 7.3
|
PRIMARY outcome
Timeframe: Within 30 days after Vaccination 3Population: Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).
A medically attended AE was defined as a non-serious AE that required medical attention.
Outcome measures
| Measure |
Group 1: rLP2086
n=3313 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1710 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
|
5.34 percentage of participants
Interval 4.6 to 6.2
|
5.50 percentage of participants
Interval 4.5 to 6.7
|
SECONDARY outcome
Timeframe: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)Population: Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
30 days after Vaccination 3 (N=3313, 1710)
|
0.33 percentage of participants
Interval 0.2 to 0.6
|
0.12 percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
30 days after any vaccination (N=3796, 1908)
|
0.61 percentage of participants
Interval 0.4 to 0.9
|
0.94 percentage of participants
Interval 0.6 to 1.5
|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
Vaccination phase (N=3796, 1908)
|
1.16 percentage of participants
Interval 0.8 to 1.6
|
1.83 percentage of participants
Interval 1.3 to 2.5
|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
Follow-up phase (N=3400, 1733)
|
0.44 percentage of participants
Interval 0.2 to 0.7
|
0.87 percentage of participants
Interval 0.5 to 1.4
|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
30 days after Vaccination 1 (N=3796, 1908)
|
0.18 percentage of participants
Interval 0.1 to 0.4
|
0.42 percentage of participants
Interval 0.2 to 0.8
|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
30 days after Vaccination 2 (N=3529, 1806)
|
0.17 percentage of participants
Interval 0.1 to 0.4
|
0.44 percentage of participants
Interval 0.2 to 0.9
|
SECONDARY outcome
Timeframe: Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)Population: Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
A medically attended AE was defined as a non-serious AE that required medical attention.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
30 days after any vaccination (N=3796, 1908)
|
14.38 percentage of participants
Interval 13.3 to 15.5
|
14.57 percentage of participants
Interval 13.0 to 16.2
|
|
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Vaccination phase (N=3796, 1908)
|
24.60 percentage of participants
Interval 23.2 to 26.0
|
24.53 percentage of participants
Interval 22.6 to 26.5
|
|
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Follow-up phase (N=3400, 1733)
|
11.24 percentage of participants
Interval 10.2 to 12.3
|
11.43 percentage of participants
Interval 10.0 to 13.0
|
|
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Throughout study (N=3796, 1908)
|
29.00 percentage of participants
Interval 27.6 to 30.5
|
29.04 percentage of participants
Interval 27.0 to 31.1
|
SECONDARY outcome
Timeframe: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)Population: Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
30 days after Vaccination 1 (N=3796, 1908)
|
0.21 percentage of participants
Interval 0.1 to 0.4
|
0.10 percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
30 days after any vaccination (N=3796, 1908)
|
0.45 percentage of participants
Interval 0.3 to 0.7
|
0.52 percentage of participants
Interval 0.3 to 1.0
|
|
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Vaccination phase (N=3796, 1908)
|
1.03 percentage of participants
Interval 0.7 to 1.4
|
1.05 percentage of participants
Interval 0.6 to 1.6
|
|
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
30 days after Vaccination 2 (N=3529, 1806)
|
0.17 percentage of participants
Interval 0.1 to 0.4
|
0.33 percentage of participants
Interval 0.1 to 0.7
|
|
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
30 days after Vaccination 3 (N=3313, 1710)
|
0.09 percentage of participants
Interval 0.0 to 0.3
|
0.12 percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Follow-up phase (N=3400, 1733)
|
0.44 percentage of participants
Interval 0.2 to 0.7
|
0.52 percentage of participants
Interval 0.2 to 1.0
|
|
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Throughout study (N=3796, 1908)
|
1.40 percentage of participants
Interval 1.0 to 1.8
|
1.52 percentage of participants
Interval 1.0 to 2.2
|
SECONDARY outcome
Timeframe: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)Population: Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
30 days after any vaccination (N=3796, 1908)
|
43.02 percentage of participants
Interval 41.4 to 44.6
|
31.45 percentage of participants
Interval 29.4 to 33.6
|
|
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
Vaccination phase (N=3796, 1908)
|
51.08 percentage of participants
Interval 49.5 to 52.7
|
42.51 percentage of participants
Interval 40.3 to 44.8
|
|
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
30 days after Vaccination 1 (N=3796, 1908)
|
31.48 percentage of participants
Interval 30.0 to 33.0
|
19.03 percentage of participants
Interval 17.3 to 20.9
|
|
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
30 days after Vaccination 2 (N=3529, 1806)
|
20.37 percentage of participants
Interval 19.1 to 21.7
|
12.35 percentage of participants
Interval 10.9 to 14.0
|
|
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
30 days after Vaccination 3 (N=3313, 1710)
|
15.00 percentage of participants
Interval 13.8 to 16.3
|
10.76 percentage of participants
Interval 9.3 to 12.3
|
SECONDARY outcome
Timeframe: Within 30 minutes after Vaccination 1, 2, 3Population: Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Vaccination 2 (N=3529, 1806)
|
0.54 percentage of participants
Interval 0.3 to 0.8
|
0.06 percentage of participants
Interval 0.0 to 0.3
|
|
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Vaccination 3 (N=3313, 1710)
|
0.45 percentage of participants
Interval 0.3 to 0.7
|
0.41 percentage of participants
Interval 0.2 to 0.8
|
|
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Vaccination 1 (N=3796, 1908)
|
1.05 percentage of participants
Interval 0.8 to 1.4
|
0.84 percentage of participants
Interval 0.5 to 1.4
|
SECONDARY outcome
Timeframe: Vaccination 1 up to 1 month after Vaccination 3Population: Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.
Outcome measures
| Measure |
Group 1: rLP2086
n=3796 Participants
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 Participants
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
|
3.0 days
Full Range 7.01 • Interval 1.0 to 110.0
|
3.0 days
Full Range 9.67 • Interval 1.0 to 136.0
|
Adverse Events
Group 1: rLP2086
Serious events: 59 serious events
Other events: 1671 other events
Deaths: 0 deaths
Group 2: HAV/Saline/HAV
Serious events: 48 serious events
Other events: 640 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: rLP2086
n=3796 participants at risk
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 participants at risk
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.10%
2/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.10%
2/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Appendicitis
|
0.08%
3/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.21%
4/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.16%
3/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Peritonsillar abscess
|
0.05%
2/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Meningitis viral
|
0.05%
2/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Breast abscess
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Carbuncle
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Cystitis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Meningitis enterococcal
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Meningitis enteroviral
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pertussis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pilonidal cyst
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Postoperative wound infection
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Salpingitis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Tick-borne viral encephalitis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.10%
2/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.05%
2/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central Nervous System germinoma
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Migraine
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Multiple sclerosis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Demyelination
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Headache
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Meningism
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.05%
2/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.16%
3/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Suicidal ideation
|
0.08%
3/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.16%
3/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Substance abuse
|
0.05%
2/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Attention deficit or hyperactivity disorder
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Psychotic disorder
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
3/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pyelonephritis
|
0.03%
1/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.05%
1/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
Other adverse events
| Measure |
Group 1: rLP2086
n=3796 participants at risk
Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
|
Group 2: HAV/Saline/HAV
n=1908 participants at risk
Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.3%
89/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.7%
33/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
60/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.4%
27/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
47/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.7%
32/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
42/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.89%
17/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site pain
|
19.0%
722/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
7.8%
149/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Pyrexia
|
6.2%
237/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
2.3%
44/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site erythema
|
3.7%
142/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.31%
6/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Vaccination site pain
|
3.3%
126/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.47%
9/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Fatigue
|
2.2%
82/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.00%
19/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site swelling
|
2.2%
84/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.31%
6/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
157/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
4.6%
87/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
149/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
4.4%
84/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pharyngitis
|
2.0%
75/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
2.5%
47/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
1.7%
64/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
2.0%
38/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Bronchitis
|
1.7%
65/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.9%
36/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Sinusitis
|
1.4%
54/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.7%
33/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Urinary tract infection
|
1.3%
50/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.3%
24/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.2%
45/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.2%
22/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Tonsillitis
|
1.0%
38/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.1%
21/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Viral pharyngitis
|
1.1%
41/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
0.68%
13/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.6%
60/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.6%
30/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
50/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.2%
23/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
38/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.3%
24/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
76/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.4%
26/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
49/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.4%
26/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
40/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.4%
27/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Headache
|
6.6%
249/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
5.3%
102/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
83/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
2.1%
41/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
73/3796 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
1.8%
34/1908 • AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER