Trial Outcomes & Findings for A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age (NCT NCT05496231)
NCT ID: NCT05496231
Last Updated: 2025-02-03
Results Overview
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter greater than (\>) 50 millimeters (mm).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1080 participants
Primary outcome timeframe
Within 7 days after vaccine Dose 1 (administered at Day 1)
Results posted on
2025-02-03
Participant Flow
This study was organized into 2 steps. Step 1 sentinel participants received the initial assigned dose prior to participants in Step 2 of the study, and sentinel participants had an additional blood sampling visit at Day 7 to assess for biochemical and hematological parameters.
A total of 1080 participants were enrolled into the study, of which 1079 participants received at least 1 dose of vaccine and were included in the Exposed Set.
Participant milestones
| Measure |
HPV9 High Group
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
270
|
270
|
269
|
270
|
|
Overall Study
COMPLETED
|
239
|
246
|
244
|
238
|
|
Overall Study
NOT COMPLETED
|
31
|
24
|
25
|
32
|
Reasons for withdrawal
| Measure |
HPV9 High Group
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
4
|
11
|
|
Overall Study
Migrated/moved from the study area
|
3
|
5
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
13
|
6
|
11
|
6
|
|
Overall Study
Other
|
9
|
7
|
7
|
8
|
Baseline Characteristics
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age
Baseline characteristics by cohort
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
Total
n=1079 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
22.0 Years
STANDARD_DEVIATION 2.32 • n=5 Participants
|
21.9 Years
STANDARD_DEVIATION 2.56 • n=7 Participants
|
22.1 Years
STANDARD_DEVIATION 2.45 • n=5 Participants
|
22.2 Years
STANDARD_DEVIATION 2.25 • n=4 Participants
|
22.1 Years
STANDARD_DEVIATION 2.40 • n=21 Participants
|
|
Sex: Female, Male
Female
|
270 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
1079 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
245 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
244 Participants
n=4 Participants
|
976 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine Dose 1 (administered at Day 1)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the electronic diary (eDiary) for solicited events completed after the administration of vaccine Dose 1 and for whom data were available during the specified period.
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter greater than (\>) 50 millimeters (mm).
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1
Grade 3 Pain
|
11 Participants
|
12 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1
Grade 3 Redness
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1
Grade 3 Swelling
|
5 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine Dose 2 (administered at Month 2)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 2 and for whom data were available during the specified period.
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter \>50 mm.
Outcome measures
| Measure |
HPV9 High Group
n=257 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=261 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=258 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=260 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2
Grade 3 Pain
|
13 Participants
|
6 Participants
|
11 Participants
|
1 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2
Grade 3 Redness
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2
Grade 3 Swelling
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine Dose 3 (administered at Month 6)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 3 and for whom data were available during the specified period.
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter \>50 mm.
Outcome measures
| Measure |
HPV9 High Group
n=244 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=247 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=244 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=236 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3
Grade 3 Pain
|
9 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3
Grade 3 Redness
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3
Grade 3 Swelling
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine Dose 1 (administered at Day 1)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 1 and for whom data were available during the specified period.
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0 degrees Celsius (°C) or 102.2 Fahrenheit (°F). The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activities.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Grade 3 Fever
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Grade 3 Headache
|
11 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Grade 3 Myalgia
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Grade 3 Arthralgia
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1
Grade 3 Fatigue
|
12 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine Dose 2 (administered at Month 2)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 2 and for whom data were available during the specified period.
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Outcome measures
| Measure |
HPV9 High Group
n=257 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=261 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=258 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=260 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Grade 3 Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Grade 3 Headache
|
7 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Grade 3 Myalgia
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Grade 3 Arthralgia
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2
Grade 3 Fatigue
|
12 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine Dose 3 (administered at Month 6)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of vaccine Dose 3 and for whom data were available during the specified period.
Assessed solicited systemic events included fever, headache, myalgia, arthralgia and fatigue. Grade 3 fever = body temperature \>39.0°C or 102.2°F. The preferred location for measuring temperature was the axilla. Grade 3 headache, myalgia, arthralgia and fatigue = symptoms that prevented normal, every day activity.
Outcome measures
| Measure |
HPV9 High Group
n=244 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=247 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=244 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=236 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Grade 3 Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Grade 3 Headache
|
10 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Grade 3 Myalgia
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Grade 3 Arthralgia
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3
Grade 3 Fatigue
|
15 Participants
|
8 Participants
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Within 28 days after vaccine Dose 1 (administered at Day 1)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of vaccine Dose 1.
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/legally acceptable representative(s) \[LAR(s)\] who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 28 days after vaccine Dose 2 (administered at Month 2)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of vaccine Dose 2.
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Outcome measures
| Measure |
HPV9 High Group
n=257 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=261 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=258 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=260 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 28 days after vaccine Dose 3 (administered at Month 6)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of vaccine Dose 3.
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Grade 3 unsolicited AEs = an AE which prevented normal, everyday activities.
Outcome measures
| Measure |
HPV9 High Group
n=244 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=247 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=244 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=236 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first vaccination (Day 1) to study end (Month 12)Population: Analysis was performed on the Exposed Set, which included participants who received a study vaccine and for whom data were available for the specified period.
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: Analysis was performed on the Step 1 subset from the Exposed Set, which included sentinel adult participants for whom blood samples were collected for the specified biochemical analyses at Day 7.
As pre-specified in the protocol, the assessed biochemical parameters were blood urea nitrogen (BUN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Unknown = parameter value missing for the specified parameter.
Outcome measures
| Measure |
HPV9 High Group
n=12 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=12 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=12 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=12 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
BUN, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
AST, Grade 0
|
11 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
AST, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
ALT, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
ALT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
ALT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
BUN, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
BUN, Grade 0
|
11 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
BUN, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
BUN, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
BUN, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
AST, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
AST, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
AST, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
AST, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
ALT, Grade 0
|
11 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
ALT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities
ALT, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: Analysis was performed on the Step 1 subset from the Exposed Set, which included sentinel adult participants for whom blood samples were collected for the specified hematological analyses at Day 7.
As pre-specified in the protocol, the assessed hematological parameters were hemoglobin, white blood cells (WBC) increase, WBC decrease, lymphocyte decrease, neutrophils decrease, eosinophils, and platelets decrease. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter.
Outcome measures
| Measure |
HPV9 High Group
n=12 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=12 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=12 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=12 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Hemoglobin, Grade 0
|
8 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Hemoglobin, Grade 1
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Hemoglobin, Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Increase, Grade 0
|
11 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Increase, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Increase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Increase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Increase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Increase, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Decrease, Grade 0
|
11 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Decrease, Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Decrease, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Decrease, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Lymphocyte Decrease, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Lymphocyte Decrease, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Decrease, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
WBC Decrease, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Hemoglobin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Lymphocyte Decrease, Grade 0
|
11 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Lymphocyte Decrease, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Lymphocyte Decrease, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Neutrophils Decrease, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Lymphocyte Decrease, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Neutrophils Decrease, Grade 0
|
10 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Neutrophils Decrease, Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Neutrophils Decrease, Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Hemoglobin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Hemoglobin, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Neutrophils Decrease, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Eosinophils, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Eosinophils, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Eosinophils, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Eosinophils, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Neutrophils Decrease, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Eosinophils, Grade 0
|
11 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Eosinophils, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Platelet Decrease, Grade 0
|
11 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Platelet Decrease, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Platelet Decrease, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Platelet Decrease, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Platelet Decrease, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities
Platelet Decrease, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7 compared to baseline (Day 1)Population: Analysis was performed on the Step 1 subset from the Exposed Set, which included sentinel adult participants for whom blood samples were collected for the hemoglobin change from baseline analysis at Day 7.
The number of participants with clinically relevant abnormalities in hemoglobin change from baseline levels is reported. Assessment of intensity: Grading of the biochemical parameters was based on the institutional normal reference ranges and derived from the standard FDA Toxicity Grading Scale. Changes compared to normal reference ranges were graded as follows: Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening; Unknown = parameter value missing for the specified parameter. Change from baseline = the difference between a participant's baseline (pre-intervention) parameter values and their follow-up (post-intervention) parameter values.
Outcome measures
| Measure |
HPV9 High Group
n=12 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=12 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=12 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=12 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
Hemoglobin change from baseline, Grade 0
|
5 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
Hemoglobin change from baseline, Grade 1
|
5 Participants
|
11 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
Hemoglobin change from baseline, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
Hemoglobin change from baseline, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
Hemoglobin change from baseline, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels
Hemoglobin change from baseline, Unknown
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 7 (one month after vaccine Dose 3 administration)Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time point. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
Anti-HPV IgG antibody concentrations were determined by electrochemiluminescence (ECL) assay and expressed as geometric mean concentrations (GMCs) in arbitrary units per milliliter (AU/mL). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Outcome measures
| Measure |
HPV9 High Group
n=211 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=201 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=206 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=203 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 18 type antigen
|
181939.71 AU/mL
Interval 157766.95 to 209816.17
|
172862.73 AU/mL
Interval 148117.04 to 201742.65
|
183180.47 AU/mL
Interval 156207.11 to 214811.5
|
86756.51 AU/mL
Interval 73744.88 to 102063.92
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 31 type antigen
|
241644.97 AU/mL
Interval 215104.3 to 271460.37
|
221590.60 AU/mL
Interval 192869.71 to 254588.41
|
230875.63 AU/mL
Interval 202104.78 to 263742.19
|
104667.37 AU/mL
Interval 90853.53 to 120581.53
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 33 type antigen
|
154537.14 AU/mL
Interval 133354.03 to 179085.17
|
146931.12 AU/mL
Interval 125717.81 to 171723.9
|
150919.88 AU/mL
Interval 128301.37 to 177525.85
|
96875.65 AU/mL
Interval 84426.91 to 111159.96
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 45 type antigen
|
170959.55 AU/mL
Interval 149389.05 to 195644.64
|
174740.31 AU/mL
Interval 151200.15 to 201945.41
|
174014.45 AU/mL
Interval 150322.39 to 201440.58
|
71768.92 AU/mL
Interval 61224.65 to 84129.14
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 52 type antigen
|
203994.24 AU/mL
Interval 180491.88 to 230556.91
|
196454.98 AU/mL
Interval 172561.35 to 223657.02
|
204005.75 AU/mL
Interval 178367.04 to 233329.81
|
103497.80 AU/mL
Interval 90571.68 to 118268.69
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 58 type antigen
|
193735.34 AU/mL
Interval 167223.71 to 224450.13
|
186513.90 AU/mL
Interval 161169.95 to 215843.18
|
190767.16 AU/mL
Interval 162753.08 to 223603.2
|
93456.26 AU/mL
Interval 80147.35 to 108975.18
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 6 type antigen
|
124141.35 AU/mL
Interval 110854.94 to 139020.2
|
117881.81 AU/mL
Interval 103701.9 to 134000.65
|
119724.25 AU/mL
Interval 105236.23 to 136206.84
|
54710.66 AU/mL
Interval 47259.35 to 63336.8
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 11 type antigen
|
276225.68 AU/mL
Interval 243524.62 to 313317.91
|
250405.46 AU/mL
Interval 217218.09 to 288663.3
|
260309.15 AU/mL
Interval 223319.56 to 303425.52
|
187507.09 AU/mL
Interval 162968.13 to 215740.99
|
|
Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations
HPV 16 type antigen
|
297480.37 AU/mL
Interval 254936.96 to 347123.34
|
272728.60 AU/mL
Interval 231905.67 to 320737.69
|
294326.70 AU/mL
Interval 252346.28 to 343290.99
|
154844.90 AU/mL
Interval 131166.44 to 182797.86
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of each vaccine dose and for whom data were available during the specified period.
Assessed solicited administration site events included pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any pain, post-dose 1
|
240 Participants
|
244 Participants
|
245 Participants
|
188 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any redness, post-dose 1
|
71 Participants
|
70 Participants
|
91 Participants
|
47 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any swelling, post-dose 1
|
61 Participants
|
54 Participants
|
66 Participants
|
21 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any pain, post-dose 2
|
208 Participants
|
221 Participants
|
218 Participants
|
185 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any redness, post-dose 2
|
79 Participants
|
83 Participants
|
69 Participants
|
46 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any swelling, post-dose 2
|
68 Participants
|
55 Participants
|
59 Participants
|
35 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any pain, post-dose 3
|
188 Participants
|
191 Participants
|
191 Participants
|
155 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any redness, post-dose 3
|
61 Participants
|
64 Participants
|
64 Participants
|
37 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Any swelling, post-dose 3
|
59 Participants
|
52 Participants
|
58 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine, had the eDiary for solicited events completed after the administration of each vaccine dose and for whom data were available during the specified period.
Assessed solicited systemic events included fever (defined as body temperature \>=37.5°C/99.5°F), headache, myalgia, arthralgia and fatigue. The preferred location for measuring temperature was the axilla. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events
Any fever, post-dose 1
|
15 Participants
|
12 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any headache, post-dose 1
|
137 Participants
|
113 Participants
|
131 Participants
|
127 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any myalgia, post-dose 1
|
87 Participants
|
105 Participants
|
92 Participants
|
75 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any arthralgia, post-dose 1
|
27 Participants
|
25 Participants
|
22 Participants
|
23 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any fatigue, post-dose 1
|
180 Participants
|
166 Participants
|
146 Participants
|
149 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any fever, post-dose 2
|
8 Participants
|
13 Participants
|
9 Participants
|
16 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any headache, post-dose 2
|
113 Participants
|
106 Participants
|
118 Participants
|
101 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any myalgia, post-dose 2
|
80 Participants
|
67 Participants
|
66 Participants
|
56 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any arthralgia, post-dose 2
|
25 Participants
|
19 Participants
|
21 Participants
|
20 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any fatigue, post-dose 2
|
152 Participants
|
132 Participants
|
124 Participants
|
127 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any fever, post-dose 3
|
13 Participants
|
11 Participants
|
11 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any headache, post-dose 3
|
106 Participants
|
81 Participants
|
84 Participants
|
85 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any myalgia, post-dose 3
|
61 Participants
|
59 Participants
|
54 Participants
|
45 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any arthralgia, post-dose 3
|
21 Participants
|
15 Participants
|
19 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Any fatigue, post-dose 3
|
122 Participants
|
103 Participants
|
103 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: Within 28 days after each vaccine dose (administered at Day 1, Month 2, and Month 6)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period after the administration of each vaccine dose.
An unsolicited AE is defined as an AE that was not included in the list of solicited events using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs
Any unsolicited AEs, post-dose 1
|
70 Participants
|
72 Participants
|
70 Participants
|
70 Participants
|
|
Number of Participants Reporting Any Unsolicited AEs
Any unsolicited AEs, post-dose 2
|
51 Participants
|
38 Participants
|
58 Participants
|
55 Participants
|
|
Number of Participants Reporting Any Unsolicited AEs
Any unsolicited AEs, post-dose 3
|
37 Participants
|
41 Participants
|
45 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) to study end (Month 12)Population: Analysis was performed on the Exposed set, which included all participants who received a study vaccine and for whom data were available for the specified period.
pIMDs are defined as a subset of AEs of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of pregnancy to study end (Month 12)Population: Analysis was performed on the Exposed Set, which included all participants who received a study vaccine and for whom data were available for the specified period.
The number of participants who experienced pregnancy while participating in this study is reported.
Outcome measures
| Measure |
HPV9 High Group
n=270 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants Reporting Pregnancies
|
1 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of pregnancy up to study end (Month 12)Population: Analysis was performed on the Exposed set, which included all participants who received a study vaccine, who reported any pregnancy and for whom data were available for the specified period.
The participants with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. Pregnancy outcomes were live infant, no apparent congenital anomaly; elective termination, no apparent congenital anomaly, and ectopic pregnancy.
Outcome measures
| Measure |
HPV9 High Group
n=1 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=3 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=5 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Outcomes of Reported Pregnancies
Live infant, no apparent congenital anomaly
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Outcomes of Reported Pregnancies
Elective termination, no apparent congenital anomaly
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Outcomes of Reported Pregnancies
Ectopic pregnancy
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Month 2, Month 3, Month 6, Month 7 (Month 7 data was also reported in primary outcome measure 14, as pre-specified in protocol) and Month 12Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
Anti-HPV IgG antibody concentrations were determined by ECL assay and expressed as GMCs in AU/mL. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Outcome measures
| Measure |
HPV9 High Group
n=265 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=261 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=264 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=261 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Anti-HPV IgG Antibody Concentrations
HPV 6 type antigen, Day 1
|
3621.58 AU/mL
Interval 3245.94 to 4040.7
|
3377.84 AU/mL
Interval 3078.74 to 3705.98
|
3124.40 AU/mL
Interval 2891.32 to 3376.27
|
2970.65 AU/mL
Interval 2773.07 to 3182.3
|
|
Anti-HPV IgG Antibody Concentrations
HPV 6 type antigen, Month 2
|
29701.14 AU/mL
Interval 25289.04 to 34883.02
|
29699.92 AU/mL
Interval 25343.87 to 34804.68
|
23870.12 AU/mL
Interval 20301.64 to 28065.86
|
10488.57 AU/mL
Interval 8707.08 to 12634.56
|
|
Anti-HPV IgG Antibody Concentrations
HPV 6 type antigen, Month 3
|
113669.75 AU/mL
Interval 101762.75 to 126969.97
|
106471.07 AU/mL
Interval 95221.75 to 119049.37
|
100258.49 AU/mL
Interval 88766.41 to 113238.38
|
63245.70 AU/mL
Interval 55720.23 to 71787.54
|
|
Anti-HPV IgG Antibody Concentrations
HPV 6 type antigen, Month 6
|
42722.37 AU/mL
Interval 37809.13 to 48274.08
|
38982.11 AU/mL
Interval 34388.98 to 44188.73
|
32792.55 AU/mL
Interval 28876.62 to 37239.51
|
18744.02 AU/mL
Interval 15944.74 to 22034.74
|
|
Anti-HPV IgG Antibody Concentrations
HPV 6 type antigen, Month 7
|
124141.35 AU/mL
Interval 110854.94 to 139020.2
|
117881.81 AU/mL
Interval 103701.9 to 134000.65
|
119724.25 AU/mL
Interval 105236.23 to 136206.84
|
54710.66 AU/mL
Interval 47259.35 to 63336.8
|
|
Anti-HPV IgG Antibody Concentrations
HPV 6 type antigen, Month 12
|
68118.04 AU/mL
Interval 60118.11 to 77182.53
|
65112.37 AU/mL
Interval 56605.42 to 74897.8
|
59776.32 AU/mL
Interval 51986.07 to 68733.97
|
26890.23 AU/mL
Interval 22982.31 to 31462.65
|
|
Anti-HPV IgG Antibody Concentrations
HPV 11 type antigen, Day 1
|
2217.95 AU/mL
Interval 1860.09 to 2644.67
|
2105.07 AU/mL
Interval 1797.78 to 2464.89
|
2013.18 AU/mL
Interval 1725.27 to 2349.12
|
1794.54 AU/mL
Interval 1572.94 to 2047.37
|
|
Anti-HPV IgG Antibody Concentrations
HPV 11 type antigen, Month 2
|
41618.25 AU/mL
Interval 35124.62 to 49312.39
|
37945.17 AU/mL
Interval 32187.34 to 44732.98
|
29437.94 AU/mL
Interval 24557.93 to 35287.68
|
38760.82 AU/mL
Interval 32890.19 to 45679.3
|
|
Anti-HPV IgG Antibody Concentrations
HPV 11 type antigen, Month 3
|
231064.29 AU/mL
Interval 203232.17 to 262707.95
|
212805.15 AU/mL
Interval 185957.86 to 243528.46
|
192296.18 AU/mL
Interval 167234.4 to 221113.72
|
220402.45 AU/mL
Interval 196291.74 to 247474.71
|
|
Anti-HPV IgG Antibody Concentrations
HPV 11 type antigen, Month 6
|
77600.50 AU/mL
Interval 68286.55 to 88184.84
|
67299.61 AU/mL
Interval 58975.99 to 76798.0
|
57076.00 AU/mL
Interval 49315.68 to 66057.49
|
68934.35 AU/mL
Interval 59315.95 to 80112.44
|
|
Anti-HPV IgG Antibody Concentrations
HPV 11 type antigen, Month 7
|
276225.68 AU/mL
Interval 243524.62 to 313317.91
|
250405.46 AU/mL
Interval 217218.09 to 288663.3
|
260309.15 AU/mL
Interval 223319.56 to 303425.52
|
187507.09 AU/mL
Interval 162968.13 to 215740.99
|
|
Anti-HPV IgG Antibody Concentrations
HPV 11 type antigen, Month 12
|
129019.87 AU/mL
Interval 112127.85 to 148456.67
|
120984.83 AU/mL
Interval 103575.25 to 141320.73
|
117640.77 AU/mL
Interval 100745.01 to 137370.08
|
87423.54 AU/mL
Interval 75807.4 to 100819.64
|
|
Anti-HPV IgG Antibody Concentrations
HPV 16 type antigen, Day 1
|
684.26 AU/mL
Interval 518.08 to 903.75
|
637.99 AU/mL
Interval 490.56 to 829.73
|
690.99 AU/mL
Interval 530.87 to 899.4
|
525.21 AU/mL
Interval 416.24 to 662.71
|
|
Anti-HPV IgG Antibody Concentrations
HPV 16 type antigen, Month 2
|
34918.40 AU/mL
Interval 27711.11 to 44000.21
|
31250.65 AU/mL
Interval 24952.39 to 39138.66
|
25605.94 AU/mL
Interval 20018.8 to 32752.43
|
17397.59 AU/mL
Interval 13647.75 to 22177.73
|
|
Anti-HPV IgG Antibody Concentrations
HPV 16 type antigen, Month 3
|
252250.95 AU/mL
Interval 217434.89 to 292641.82
|
217440.98 AU/mL
Interval 184257.65 to 256600.37
|
201303.15 AU/mL
Interval 171349.89 to 236492.48
|
158136.76 AU/mL
Interval 134715.83 to 185629.53
|
|
Anti-HPV IgG Antibody Concentrations
HPV 16 type antigen, Month 6
|
101518.07 AU/mL
Interval 87448.85 to 117850.81
|
83015.52 AU/mL
Interval 71509.49 to 96372.89
|
76558.80 AU/mL
Interval 64740.19 to 90534.95
|
56636.27 AU/mL
Interval 47641.12 to 67329.8
|
|
Anti-HPV IgG Antibody Concentrations
HPV 16 type antigen, Month 7
|
297480.37 AU/mL
Interval 254936.96 to 347123.34
|
272728.60 AU/mL
Interval 231905.67 to 320737.69
|
294326.70 AU/mL
Interval 252346.28 to 343290.99
|
154844.90 AU/mL
Interval 131166.44 to 182797.86
|
|
Anti-HPV IgG Antibody Concentrations
HPV 16 type antigen, Month 12
|
166953.66 AU/mL
Interval 142318.06 to 195853.75
|
149269.66 AU/mL
Interval 125174.31 to 178003.24
|
168097.78 AU/mL
Interval 142244.2 to 198650.38
|
85986.11 AU/mL
Interval 73074.57 to 101178.98
|
|
Anti-HPV IgG Antibody Concentrations
HPV 18 type antigen, Day 1
|
1246.54 AU/mL
Interval 1036.67 to 1498.89
|
1037.54 AU/mL
Interval 885.47 to 1215.73
|
1111.98 AU/mL
Interval 948.66 to 1303.41
|
952.51 AU/mL
Interval 830.5 to 1092.44
|
|
Anti-HPV IgG Antibody Concentrations
HPV 18 type antigen, Month 2
|
21700.85 AU/mL
Interval 17733.79 to 26555.34
|
18029.88 AU/mL
Interval 14988.53 to 21688.36
|
16571.70 AU/mL
Interval 13555.92 to 20258.4
|
11081.57 AU/mL
Interval 9094.95 to 13502.12
|
|
Anti-HPV IgG Antibody Concentrations
HPV 18 type antigen, Month 3
|
137838.37 AU/mL
Interval 118980.92 to 159684.56
|
127099.14 AU/mL
Interval 108628.77 to 148710.05
|
123342.91 AU/mL
Interval 106423.5 to 142952.21
|
79998.43 AU/mL
Interval 68999.0 to 92751.33
|
|
Anti-HPV IgG Antibody Concentrations
HPV 18 type antigen, Month 6
|
61676.34 AU/mL
Interval 53576.84 to 71000.3
|
51216.03 AU/mL
Interval 44364.44 to 59125.78
|
46904.59 AU/mL
Interval 40385.36 to 54476.18
|
26774.11 AU/mL
Interval 22940.11 to 31248.9
|
|
Anti-HPV IgG Antibody Concentrations
HPV 18 type antigen, Month 7
|
181939.71 AU/mL
Interval 157766.95 to 209816.17
|
172862.73 AU/mL
Interval 148117.04 to 201742.65
|
183180.47 AU/mL
Interval 156207.11 to 214811.5
|
86756.51 AU/mL
Interval 73744.88 to 102063.92
|
|
Anti-HPV IgG Antibody Concentrations
HPV 18 type antigen, Month 12
|
84949.48 AU/mL
Interval 72424.07 to 99641.09
|
77008.45 AU/mL
Interval 64999.61 to 91235.95
|
87334.91 AU/mL
Interval 73919.46 to 103185.1
|
36658.81 AU/mL
Interval 31077.43 to 43242.59
|
|
Anti-HPV IgG Antibody Concentrations
HPV 31 type antigen, Day 1
|
2748.41 AU/mL
Interval 2441.79 to 3093.53
|
2698.81 AU/mL
Interval 2418.57 to 3011.52
|
2595.69 AU/mL
Interval 2371.22 to 2841.42
|
2358.09 AU/mL
Interval 2189.79 to 2539.33
|
|
Anti-HPV IgG Antibody Concentrations
HPV 31 type antigen, Month 2
|
32102.49 AU/mL
Interval 27409.98 to 37598.34
|
31733.68 AU/mL
Interval 27111.16 to 37144.34
|
27652.57 AU/mL
Interval 23288.94 to 32833.82
|
12606.73 AU/mL
Interval 10568.61 to 15037.9
|
|
Anti-HPV IgG Antibody Concentrations
HPV 31 type antigen, Month 3
|
161264.11 AU/mL
Interval 142962.02 to 181909.25
|
146413.17 AU/mL
Interval 128682.36 to 166587.07
|
133818.05 AU/mL
Interval 117762.32 to 152062.83
|
89306.66 AU/mL
Interval 79122.92 to 100801.13
|
|
Anti-HPV IgG Antibody Concentrations
HPV 31 type antigen, Month 6
|
68516.79 AU/mL
Interval 60395.61 to 77730.0
|
61717.39 AU/mL
Interval 54357.98 to 70073.18
|
54672.61 AU/mL
Interval 47682.67 to 62687.23
|
32131.34 AU/mL
Interval 27928.72 to 36966.36
|
|
Anti-HPV IgG Antibody Concentrations
HPV 31 type antigen, Month 7
|
241644.97 AU/mL
Interval 215104.3 to 271460.37
|
221590.60 AU/mL
Interval 192869.71 to 254588.41
|
230875.63 AU/mL
Interval 202104.78 to 263742.19
|
104667.37 AU/mL
Interval 90853.53 to 120581.53
|
|
Anti-HPV IgG Antibody Concentrations
HPV 31 type antigen, Month 12
|
137744.87 AU/mL
Interval 120414.0 to 157570.13
|
132414.54 AU/mL
Interval 113520.94 to 154452.65
|
143396.41 AU/mL
Interval 125201.11 to 164236.01
|
55178.34 AU/mL
Interval 47206.87 to 64495.9
|
|
Anti-HPV IgG Antibody Concentrations
HPV 33 type antigen, Day 1
|
624.29 AU/mL
Interval 528.02 to 738.12
|
578.18 AU/mL
Interval 489.56 to 682.84
|
566.26 AU/mL
Interval 487.33 to 657.97
|
523.15 AU/mL
Interval 456.49 to 599.54
|
|
Anti-HPV IgG Antibody Concentrations
HPV 33 type antigen, Month 2
|
18225.37 AU/mL
Interval 15231.33 to 21807.94
|
16873.64 AU/mL
Interval 14013.68 to 20317.26
|
14523.05 AU/mL
Interval 12060.26 to 17488.76
|
12110.80 AU/mL
Interval 10065.98 to 14571.01
|
|
Anti-HPV IgG Antibody Concentrations
HPV 33 type antigen, Month 3
|
124361.59 AU/mL
Interval 108348.67 to 142741.07
|
113348.19 AU/mL
Interval 96632.64 to 132955.2
|
105284.68 AU/mL
Interval 90915.5 to 121924.92
|
87895.71 AU/mL
Interval 76051.15 to 101585.0
|
|
Anti-HPV IgG Antibody Concentrations
HPV 33 type antigen, Month 6
|
43736.52 AU/mL
Interval 38187.42 to 50091.97
|
41162.19 AU/mL
Interval 35659.0 to 47514.67
|
35892.14 AU/mL
Interval 30909.82 to 41677.54
|
30563.15 AU/mL
Interval 26208.11 to 35641.88
|
|
Anti-HPV IgG Antibody Concentrations
HPV 33 type antigen, Month 7
|
154537.14 AU/mL
Interval 133354.03 to 179085.17
|
146931.12 AU/mL
Interval 125717.81 to 171723.9
|
150919.88 AU/mL
Interval 128301.37 to 177525.85
|
96875.65 AU/mL
Interval 84426.91 to 111159.96
|
|
Anti-HPV IgG Antibody Concentrations
HPV 33 type antigen, Month 12
|
79450.21 AU/mL
Interval 68289.18 to 92435.36
|
75043.46 AU/mL
Interval 63377.35 to 88857.01
|
78826.94 AU/mL
Interval 67275.95 to 92361.18
|
46210.95 AU/mL
Interval 40274.75 to 53022.09
|
|
Anti-HPV IgG Antibody Concentrations
HPV 45 type antigen, Day 1
|
2431.92 AU/mL
Interval 2233.39 to 2648.1
|
2408.58 AU/mL
Interval 2235.09 to 2595.54
|
2315.53 AU/mL
Interval 2182.69 to 2456.46
|
2217.15 AU/mL
Interval 2109.75 to 2330.02
|
|
Anti-HPV IgG Antibody Concentrations
HPV 45 type antigen, Month 2
|
17122.75 AU/mL
Interval 14408.88 to 20347.76
|
17097.47 AU/mL
Interval 14406.77 to 20290.7
|
14345.03 AU/mL
Interval 12174.35 to 16902.74
|
6292.08 AU/mL
Interval 5323.98 to 7436.22
|
|
Anti-HPV IgG Antibody Concentrations
HPV 45 type antigen, Month 3
|
137598.43 AU/mL
Interval 121615.96 to 155681.28
|
127933.76 AU/mL
Interval 111246.84 to 147123.69
|
113479.94 AU/mL
Interval 99528.64 to 129386.85
|
55337.26 AU/mL
Interval 48187.68 to 63547.61
|
|
Anti-HPV IgG Antibody Concentrations
HPV 45 type antigen, Month 6
|
45691.56 AU/mL
Interval 40155.51 to 51990.83
|
41003.12 AU/mL
Interval 35887.26 to 46848.26
|
34796.86 AU/mL
Interval 30257.59 to 40017.12
|
16153.45 AU/mL
Interval 13858.32 to 18828.69
|
|
Anti-HPV IgG Antibody Concentrations
HPV 45 type antigen, Month 7
|
170959.55 AU/mL
Interval 149389.05 to 195644.64
|
174740.31 AU/mL
Interval 151200.15 to 201945.41
|
174014.45 AU/mL
Interval 150322.39 to 201440.58
|
71768.92 AU/mL
Interval 61224.65 to 84129.14
|
|
Anti-HPV IgG Antibody Concentrations
HPV 45 type antigen, Month 12
|
78692.83 AU/mL
Interval 68331.72 to 90624.98
|
80653.92 AU/mL
Interval 68737.56 to 94636.11
|
82021.92 AU/mL
Interval 70210.67 to 95820.12
|
29716.61 AU/mL
Interval 25237.04 to 34991.31
|
|
Anti-HPV IgG Antibody Concentrations
HPV 52 type antigen, Day 1
|
1641.65 AU/mL
Interval 1464.3 to 1840.48
|
1720.51 AU/mL
Interval 1525.62 to 1940.31
|
1611.71 AU/mL
Interval 1461.9 to 1776.89
|
1549.58 AU/mL
Interval 1410.22 to 1702.72
|
|
Anti-HPV IgG Antibody Concentrations
HPV 52 type antigen, Month 2
|
75187.13 AU/mL
Interval 66352.61 to 85197.91
|
83557.87 AU/mL
Interval 73382.84 to 95143.74
|
73047.67 AU/mL
Interval 63982.97 to 83396.59
|
25513.64 AU/mL
Interval 21690.75 to 30010.3
|
|
Anti-HPV IgG Antibody Concentrations
HPV 52 type antigen, Month 3
|
185490.54 AU/mL
Interval 166270.48 to 206932.34
|
176024.77 AU/mL
Interval 153898.9 to 201331.66
|
164122.51 AU/mL
Interval 144482.99 to 186431.62
|
95239.18 AU/mL
Interval 84388.59 to 107484.91
|
|
Anti-HPV IgG Antibody Concentrations
HPV 52 type antigen, Month 6
|
75353.61 AU/mL
Interval 66851.68 to 84936.78
|
77979.01 AU/mL
Interval 68903.19 to 88250.29
|
65136.98 AU/mL
Interval 56955.32 to 74493.93
|
32359.34 AU/mL
Interval 28207.45 to 37122.36
|
|
Anti-HPV IgG Antibody Concentrations
HPV 52 type antigen, Month 7
|
203994.24 AU/mL
Interval 180491.88 to 230556.91
|
196454.98 AU/mL
Interval 172561.35 to 223657.02
|
204005.75 AU/mL
Interval 178367.04 to 233329.81
|
103497.80 AU/mL
Interval 90571.68 to 118268.69
|
|
Anti-HPV IgG Antibody Concentrations
HPV 52 type antigen, Month 12
|
123724.49 AU/mL
Interval 107358.59 to 142585.25
|
131043.47 AU/mL
Interval 113718.55 to 151007.84
|
129678.87 AU/mL
Interval 113220.94 to 148529.14
|
54071.66 AU/mL
Interval 46680.66 to 62632.89
|
|
Anti-HPV IgG Antibody Concentrations
HPV 58 type antigen, Day 1
|
692.12 AU/mL
Interval 578.03 to 828.72
|
615.45 AU/mL
Interval 518.19 to 730.95
|
643.72 AU/mL
Interval 548.71 to 755.18
|
571.59 AU/mL
Interval 492.66 to 663.17
|
|
Anti-HPV IgG Antibody Concentrations
HPV 58 type antigen, Month 2
|
35027.13 AU/mL
Interval 29855.93 to 41094.0
|
33438.25 AU/mL
Interval 28322.91 to 39477.45
|
30732.28 AU/mL
Interval 26045.95 to 36261.8
|
13395.37 AU/mL
Interval 11180.86 to 16048.5
|
|
Anti-HPV IgG Antibody Concentrations
HPV 58 type antigen, Month 3
|
158592.29 AU/mL
Interval 139984.81 to 179673.18
|
144355.15 AU/mL
Interval 124064.76 to 167963.98
|
140028.57 AU/mL
Interval 120462.67 to 162772.43
|
79942.78 AU/mL
Interval 69460.78 to 92006.58
|
|
Anti-HPV IgG Antibody Concentrations
HPV 58 type antigen, Month 6
|
70466.12 AU/mL
Interval 61803.06 to 80343.5
|
66072.77 AU/mL
Interval 57862.76 to 75447.68
|
57807.95 AU/mL
Interval 49486.07 to 67529.3
|
33188.99 AU/mL
Interval 28367.5 to 38829.98
|
|
Anti-HPV IgG Antibody Concentrations
HPV 58 type antigen, Month 7
|
193735.34 AU/mL
Interval 167223.71 to 224450.13
|
186513.90 AU/mL
Interval 161169.95 to 215843.18
|
190767.16 AU/mL
Interval 162753.08 to 223603.2
|
93456.26 AU/mL
Interval 80147.35 to 108975.18
|
|
Anti-HPV IgG Antibody Concentrations
HPV 58 type antigen, Month 12
|
114626.18 AU/mL
Interval 98236.18 to 133750.73
|
110249.43 AU/mL
Interval 93894.97 to 129452.48
|
115765.42 AU/mL
Interval 99881.91 to 134174.76
|
51715.19 AU/mL
Interval 44122.31 to 60614.71
|
SECONDARY outcome
Timeframe: At Month 2, Month 3, Month 6, Month 7 and Month 12Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
Seroconversion is defined as the appearance of antibodies \[i.e., concentration greater than or equal to (\>=) the lower limit of quantification (LLOQ) value\] in the serum of participants seronegative \[i.e, concentrations less than (\<) the LLOQ value\] before vaccination. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 5100 AU/mL; HPV 11 type: LLOQ = 2480 AU/mL; HPV 16 type: LLOQ = 404 AU/mL; HPV 18 type: LLOQ = 1234 AU/mL; HPV 31 type: LLOQ = 3849 AU/mL; HPV 33 type: LLOQ = 617 AU/mL; HPV 45 type: LLOQ = 4079 AU/mL; HPV 52 type: LLOQ = 2352 AU/mL and HPV 58 type: LLOQ = 660 AU/mL.
Outcome measures
| Measure |
HPV9 High Group
n=217 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=216 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=220 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=222 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 6 type antigen, Month 2
|
186 Participants
|
186 Participants
|
189 Participants
|
137 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 6 type antigen, Month 3
|
186 Participants
|
197 Participants
|
201 Participants
|
211 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 6 type antigen, Month 6
|
187 Participants
|
189 Participants
|
191 Participants
|
173 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 6 type antigen, Month 7
|
179 Participants
|
174 Participants
|
178 Participants
|
186 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 6 type antigen, Month 12
|
165 Participants
|
170 Participants
|
174 Participants
|
172 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 11 type antigen, Month 2
|
198 Participants
|
192 Participants
|
190 Participants
|
208 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 11 type antigen, Month 3
|
192 Participants
|
192 Participants
|
191 Participants
|
206 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 11 type antigen, Month 6
|
189 Participants
|
185 Participants
|
183 Participants
|
187 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 11 type antigen, Month 7
|
183 Participants
|
172 Participants
|
169 Participants
|
182 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 11 type antigen, Month 12
|
177 Participants
|
175 Participants
|
171 Participants
|
184 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 16 type antigen, Month 2
|
170 Participants
|
163 Participants
|
169 Participants
|
177 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 16 type antigen, Month 3
|
166 Participants
|
162 Participants
|
170 Participants
|
172 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 16 type antigen, Month 6
|
161 Participants
|
154 Participants
|
165 Participants
|
164 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 16 type antigen, Month 7
|
156 Participants
|
144 Participants
|
152 Participants
|
157 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 16 type antigen, Month 12
|
155 Participants
|
147 Participants
|
151 Participants
|
160 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 18 type antigen, Month 2
|
187 Participants
|
186 Participants
|
185 Participants
|
187 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 18 type antigen, Month 3
|
182 Participants
|
189 Participants
|
185 Participants
|
192 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 18 type antigen, Month 6
|
180 Participants
|
182 Participants
|
178 Participants
|
177 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 18 type antigen, Month 7
|
174 Participants
|
168 Participants
|
164 Participants
|
170 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 18 type antigen, Month 12
|
170 Participants
|
174 Participants
|
163 Participants
|
173 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 31 type antigen, Month 2
|
199 Participants
|
192 Participants
|
189 Participants
|
171 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 31 type antigen, Month 3
|
192 Participants
|
192 Participants
|
191 Participants
|
202 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 31 type antigen, Month 6
|
193 Participants
|
185 Participants
|
185 Participants
|
184 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 31 type antigen, Month 7
|
186 Participants
|
170 Participants
|
170 Participants
|
180 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 31 type antigen, Month 12
|
178 Participants
|
175 Participants
|
171 Participants
|
178 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 33 type antigen, Month 2
|
168 Participants
|
170 Participants
|
168 Participants
|
179 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 33 type antigen, Month 3
|
159 Participants
|
166 Participants
|
166 Participants
|
172 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 33 type antigen, Month 6
|
153 Participants
|
158 Participants
|
152 Participants
|
157 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 33 type antigen, Month 7
|
154 Participants
|
157 Participants
|
148 Participants
|
156 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 33 type antigen, Month 12
|
153 Participants
|
159 Participants
|
151 Participants
|
161 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 45 type antigen, Month 2
|
190 Participants
|
190 Participants
|
191 Participants
|
122 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 45 type antigen, Month 3
|
203 Participants
|
206 Participants
|
213 Participants
|
212 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 45 type antigen, Month 6
|
204 Participants
|
200 Participants
|
203 Participants
|
179 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 45 type antigen, Month 7
|
192 Participants
|
185 Participants
|
189 Participants
|
188 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 45 type antigen, Month 12
|
191 Participants
|
190 Participants
|
190 Participants
|
184 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 52 type antigen, Month 2
|
202 Participants
|
198 Participants
|
197 Participants
|
194 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 52 type antigen, Month 3
|
196 Participants
|
195 Participants
|
195 Participants
|
194 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 52 type antigen, Month 6
|
195 Participants
|
190 Participants
|
187 Participants
|
182 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 52 type antigen, Month 7
|
186 Participants
|
176 Participants
|
175 Participants
|
173 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 52 type antigen, Month 12
|
180 Participants
|
180 Participants
|
174 Participants
|
175 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 58 type antigen, Month 2
|
180 Participants
|
180 Participants
|
170 Participants
|
186 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 58 type antigen, Month 3
|
173 Participants
|
181 Participants
|
170 Participants
|
180 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 58 type antigen, Month 6
|
172 Participants
|
174 Participants
|
163 Participants
|
168 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 58 type antigen, Month 7
|
165 Participants
|
162 Participants
|
152 Participants
|
161 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV IgG Antibodies
HPV 58 type antigen, Month 12
|
156 Participants
|
164 Participants
|
151 Participants
|
164 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Month 3 and Month 7Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
Anti-HPV neutralizing titers were determined by pseudovirion-based neutralization (PBNA) assay and expressed as geometric mean titers (GMTs). The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Outcome measures
| Measure |
HPV9 High Group
n=266 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=261 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=264 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=261 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Anti-HPV Neutralizing Titers
HPV 6 type antigen, Day 1
|
328.72 Titers
Interval 265.51 to 406.99
|
280.37 Titers
Interval 232.07 to 338.73
|
242.72 Titers
Interval 206.0 to 286.0
|
230.40 Titers
Interval 196.29 to 270.43
|
|
Anti-HPV Neutralizing Titers
HPV 6 type antigen, Month 3
|
45690.44 Titers
Interval 39581.97 to 52741.61
|
41126.63 Titers
Interval 35026.8 to 48288.74
|
39346.74 Titers
Interval 33229.37 to 46590.3
|
21637.85 Titers
Interval 18354.48 to 25508.56
|
|
Anti-HPV Neutralizing Titers
HPV 6 type antigen, Month 7
|
82061.27 Titers
Interval 70437.95 to 95602.62
|
75228.75 Titers
Interval 61603.93 to 91866.94
|
71805.19 Titers
Interval 57989.96 to 88911.69
|
33651.69 Titers
Interval 27317.93 to 41453.96
|
|
Anti-HPV Neutralizing Titers
HPV 11 type antigen, Day 1
|
225.65 Titers
Interval 193.18 to 263.58
|
210.97 Titers
Interval 183.33 to 242.77
|
204.12 Titers
Interval 178.72 to 233.13
|
189.59 Titers
Interval 168.38 to 213.47
|
|
Anti-HPV Neutralizing Titers
HPV 11 type antigen, Month 3
|
13233.27 Titers
Interval 11647.45 to 15035.0
|
12081.23 Titers
Interval 10600.08 to 13769.35
|
10838.85 Titers
Interval 9463.76 to 12413.73
|
11547.59 Titers
Interval 10251.71 to 13007.27
|
|
Anti-HPV Neutralizing Titers
HPV 11 type antigen, Month 7
|
17321.54 Titers
Interval 14965.94 to 20047.91
|
16793.17 Titers
Interval 14214.38 to 19839.8
|
16315.93 Titers
Interval 13807.32 to 19280.31
|
12607.96 Titers
Interval 10724.69 to 14821.94
|
|
Anti-HPV Neutralizing Titers
HPV 16 type antigen, Day 1
|
361.27 Titers
Interval 291.97 to 447.02
|
325.48 Titers
Interval 270.3 to 391.92
|
356.83 Titers
Interval 294.43 to 432.46
|
277.19 Titers
Interval 236.97 to 324.24
|
|
Anti-HPV Neutralizing Titers
HPV 16 type antigen, Month 3
|
35416.74 Titers
Interval 29603.66 to 42371.29
|
31018.79 Titers
Interval 26065.77 to 36912.98
|
29774.15 Titers
Interval 24560.51 to 36094.53
|
21870.13 Titers
Interval 18225.32 to 26243.85
|
|
Anti-HPV Neutralizing Titers
HPV 16 type antigen, Month 7
|
83674.41 Titers
Interval 68253.56 to 102579.36
|
75779.10 Titers
Interval 59852.62 to 95943.55
|
81101.64 Titers
Interval 64972.49 to 101234.78
|
37820.19 Titers
Interval 29988.35 to 47697.42
|
|
Anti-HPV Neutralizing Titers
HPV 18 type antigen, Day 1
|
73.24 Titers
Interval 61.47 to 87.27
|
63.14 Titers
Interval 54.42 to 73.25
|
64.18 Titers
Interval 55.86 to 73.73
|
57.05 Titers
Interval 50.67 to 64.22
|
|
Anti-HPV Neutralizing Titers
HPV 18 type antigen, Month 3
|
3994.46 Titers
Interval 3295.05 to 4842.33
|
3610.97 Titers
Interval 3001.43 to 4344.3
|
3528.45 Titers
Interval 2908.77 to 4280.15
|
1705.98 Titers
Interval 1394.09 to 2087.65
|
|
Anti-HPV Neutralizing Titers
HPV 18 type antigen, Month 7
|
9236.06 Titers
Interval 7400.65 to 11526.67
|
9539.94 Titers
Interval 7507.03 to 12123.35
|
9756.59 Titers
Interval 7610.84 to 12507.29
|
3518.33 Titers
Interval 2745.04 to 4509.45
|
|
Anti-HPV Neutralizing Titers
HPV 31 type antigen, Day 1
|
86.49 Titers
Interval 72.6 to 103.02
|
85.98 Titers
Interval 71.95 to 102.75
|
86.03 Titers
Interval 73.71 to 100.41
|
76.01 Titers
Interval 66.25 to 87.22
|
|
Anti-HPV Neutralizing Titers
HPV 31 type antigen, Month 3
|
22472.04 Titers
Interval 19266.57 to 26210.81
|
21241.61 Titers
Interval 17729.34 to 25449.67
|
18317.84 Titers
Interval 15540.8 to 21591.12
|
9156.79 Titers
Interval 7772.33 to 10787.86
|
|
Anti-HPV Neutralizing Titers
HPV 31 type antigen, Month 7
|
69730.78 Titers
Interval 56719.94 to 85726.14
|
64413.46 Titers
Interval 49797.87 to 83318.69
|
59252.25 Titers
Interval 46942.33 to 74790.26
|
17581.92 Titers
Interval 14014.44 to 22057.53
|
|
Anti-HPV Neutralizing Titers
HPV 33 type antigen, Day 1
|
207.88 Titers
Interval 185.9 to 232.47
|
216.99 Titers
Interval 191.26 to 246.17
|
200.17 Titers
Interval 181.73 to 220.49
|
186.32 Titers
Interval 172.16 to 201.64
|
|
Anti-HPV Neutralizing Titers
HPV 33 type antigen, Month 3
|
17034.78 Titers
Interval 14730.51 to 19699.52
|
15199.08 Titers
Interval 12954.6 to 17832.44
|
12923.25 Titers
Interval 10949.5 to 15252.79
|
9132.50 Titers
Interval 7752.49 to 10758.18
|
|
Anti-HPV Neutralizing Titers
HPV 33 type antigen, Month 7
|
33246.87 Titers
Interval 27979.03 to 39506.53
|
30752.43 Titers
Interval 25717.48 to 36773.13
|
27855.80 Titers
Interval 22482.02 to 34514.06
|
18696.71 Titers
Interval 15656.33 to 22327.51
|
|
Anti-HPV Neutralizing Titers
HPV 45 type antigen, Day 1
|
55.65 Titers
Interval 48.99 to 63.21
|
61.43 Titers
Interval 53.2 to 70.94
|
53.80 Titers
Interval 48.31 to 59.93
|
49.89 Titers
Interval 45.89 to 54.25
|
|
Anti-HPV Neutralizing Titers
HPV 45 type antigen, Month 3
|
13822.73 Titers
Interval 11844.34 to 16131.59
|
13197.57 Titers
Interval 11085.72 to 15711.73
|
11113.74 Titers
Interval 9429.52 to 13098.77
|
3488.90 Titers
Interval 2963.94 to 4106.83
|
|
Anti-HPV Neutralizing Titers
HPV 45 type antigen, Month 7
|
25204.55 Titers
Interval 20693.56 to 30698.9
|
24537.36 Titers
Interval 20030.78 to 30057.86
|
22748.14 Titers
Interval 18260.65 to 28338.42
|
7853.20 Titers
Interval 6210.6 to 9930.24
|
|
Anti-HPV Neutralizing Titers
HPV 52 type antigen, Day 1
|
78.63 Titers
Interval 68.76 to 89.92
|
85.37 Titers
Interval 73.69 to 98.89
|
75.58 Titers
Interval 67.66 to 84.43
|
72.37 Titers
Interval 64.86 to 80.75
|
|
Anti-HPV Neutralizing Titers
HPV 52 type antigen, Month 3
|
18288.04 Titers
Interval 16184.95 to 20664.41
|
15548.20 Titers
Interval 13427.71 to 18003.57
|
14606.62 Titers
Interval 12634.89 to 16886.04
|
7903.98 Titers
Interval 6883.36 to 9075.93
|
|
Anti-HPV Neutralizing Titers
HPV 52 type antigen, Month 7
|
21604.03 Titers
Interval 18522.86 to 25197.74
|
20617.17 Titers
Interval 17543.87 to 24228.84
|
20285.76 Titers
Interval 17088.28 to 24081.54
|
10904.65 Titers
Interval 9006.1 to 13203.43
|
|
Anti-HPV Neutralizing Titers
HPV 58 type antigen, Day 1
|
87.31 Titers
Interval 72.7 to 104.85
|
87.15 Titers
Interval 72.02 to 105.46
|
82.06 Titers
Interval 69.3 to 97.16
|
73.81 Titers
Interval 63.25 to 86.13
|
|
Anti-HPV Neutralizing Titers
HPV 58 type antigen, Month 3
|
31623.27 Titers
Interval 27319.75 to 36604.69
|
27936.10 Titers
Interval 23519.92 to 33181.47
|
27246.89 Titers
Interval 22979.23 to 32307.15
|
11650.18 Titers
Interval 9904.82 to 13703.09
|
|
Anti-HPV Neutralizing Titers
HPV 58 type antigen, Month 7
|
51354.94 Titers
Interval 42792.24 to 61631.03
|
46896.70 Titers
Interval 38584.84 to 56999.07
|
46983.15 Titers
Interval 37929.98 to 58197.15
|
22245.13 Titers
Interval 18114.56 to 27317.58
|
SECONDARY outcome
Timeframe: At Month 2Population: Analysis was performed on a subset of participants from Per Protocol Set (PPS) for immunogenicity with post-vaccination immunogenicity results available for the specified analysis at the specified time point.
Anti-HPV neutralizing titers were determined by PBNA assay and expressed as GMTs. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens.
Outcome measures
| Measure |
HPV9 High Group
n=92 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=91 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=89 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=88 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 6 type antigen
|
13438.35 Titers
Interval 9145.74 to 19745.74
|
11275.45 Titers
Interval 7643.73 to 16632.69
|
6658.75 Titers
Interval 4614.67 to 9608.24
|
3364.11 Titers
Interval 2041.48 to 5543.64
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 11 type antigen
|
2592.37 Titers
Interval 1870.39 to 3593.02
|
2441.65 Titers
Interval 1755.07 to 3396.81
|
1531.82 Titers
Interval 1119.26 to 2096.46
|
2912.25 Titers
Interval 2156.54 to 3932.76
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 16 type antigen
|
5888.86 Titers
Interval 3547.05 to 9776.79
|
4711.97 Titers
Interval 2939.99 to 7551.96
|
2947.73 Titers
Interval 1742.01 to 4987.98
|
2987.06 Titers
Interval 1757.29 to 5077.45
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 18 type antigen
|
603.31 Titers
Interval 365.97 to 994.56
|
447.98 Titers
Interval 286.2 to 701.2
|
379.32 Titers
Interval 237.94 to 604.69
|
259.14 Titers
Interval 161.99 to 414.56
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 31 type antigen
|
4005.68 Titers
Interval 2737.23 to 5861.95
|
3612.79 Titers
Interval 2463.24 to 5298.82
|
2193.35 Titers
Interval 1620.34 to 2969.0
|
1183.70 Titers
Interval 775.15 to 1807.59
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 33 type antigen
|
1830.91 Titers
Interval 1260.56 to 2659.31
|
1782.19 Titers
Interval 1234.63 to 2572.59
|
1097.86 Titers
Interval 810.2 to 1487.66
|
1182.00 Titers
Interval 818.69 to 1706.55
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 45 type antigen
|
1382.24 Titers
Interval 973.72 to 1962.14
|
1657.88 Titers
Interval 1178.35 to 2332.56
|
1119.04 Titers
Interval 824.21 to 1519.32
|
369.17 Titers
Interval 267.2 to 510.05
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 52 type antigen
|
9664.68 Titers
Interval 7775.37 to 12013.06
|
9081.81 Titers
Interval 7013.61 to 11759.89
|
8379.90 Titers
Interval 6544.29 to 10730.38
|
4052.45 Titers
Interval 3070.88 to 5347.77
|
|
Anti-HPV Neutralizing Titers in a Subset of Participants
HPV 58 type antigen
|
5169.27 Titers
Interval 3769.39 to 7089.05
|
5519.36 Titers
Interval 3960.66 to 7691.47
|
3848.83 Titers
Interval 2823.14 to 5247.19
|
1569.91 Titers
Interval 1070.81 to 2301.63
|
SECONDARY outcome
Timeframe: At Month 3 and Month 7Population: Analysis was performed on Per Protocol Set (PPS) for immunogenicity, which included all participants from Exposed Set who met all eligibility criteria, followed the protocol for vaccine administration, adhered to vaccination schedule and blood sampling timings, and had post-vaccination immunogenicity results available for the specified analysis at the specified time points. The PPS excluded those participants with protocol deviations, interfering medications, or intercurrent medical conditions.
Seroconversion is defined as the appearance of antibodies (i.e., titer \>=LLOQ value) in the serum of participants seronegative (i.e, titer \<LLOQ value) before vaccination. The assessed antigens were: HPV 6, HPV 11, HPV 16, HPV 18, HPV 31, HPV 33, HPV 45, HPV 52 and HPV 58 type antigens. The LLOQ values specific to each antigen are as follows: HPV 6 type: LLOQ = 269 titers; HPV 11 type: LLOQ = 279 titers; HPV 16 type: LLOQ = 339 titers; HPV 18 type: LLOQ = 84 titers; HPV 31 type: LLOQ = 96 titers; HPV 33 type: LLOQ = 323 titers; HPV 45 type: LLOQ = 76 titers; HPV 52 type: LLOQ = 104 titers and HPV 58 type: LLOQ = 95 titers.
Outcome measures
| Measure |
HPV9 High Group
n=208 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=211 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=216 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=217 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 58 type antigen, Month 3
|
193 Participants
|
188 Participants
|
190 Participants
|
193 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 58 type antigen, Month 7
|
126 Participants
|
114 Participants
|
118 Participants
|
116 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 6 type antigen, Month 3
|
172 Participants
|
179 Participants
|
181 Participants
|
192 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 6 type antigen, Month 7
|
112 Participants
|
109 Participants
|
116 Participants
|
119 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 11 type antigen, Month 3
|
195 Participants
|
196 Participants
|
198 Participants
|
206 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 11 type antigen, Month 7
|
130 Participants
|
118 Participants
|
128 Participants
|
127 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 16 type antigen, Month 3
|
187 Participants
|
185 Participants
|
187 Participants
|
196 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 16 type antigen, Month 7
|
124 Participants
|
109 Participants
|
114 Participants
|
121 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 18 type antigen, Month 3
|
192 Participants
|
199 Participants
|
193 Participants
|
195 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 18 type antigen, Month 7
|
129 Participants
|
119 Participants
|
120 Participants
|
120 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 31 type antigen, Month 3
|
189 Participants
|
184 Participants
|
186 Participants
|
192 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 31 type antigen, Month 7
|
120 Participants
|
107 Participants
|
116 Participants
|
118 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 33 type antigen, Month 3
|
204 Participants
|
206 Participants
|
210 Participants
|
215 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 33 type antigen, Month 7
|
136 Participants
|
121 Participants
|
135 Participants
|
131 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 45 type antigen, Month 3
|
185 Participants
|
184 Participants
|
189 Participants
|
186 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 45 type antigen, Month 7
|
122 Participants
|
111 Participants
|
119 Participants
|
116 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 52 type antigen, Month 3
|
186 Participants
|
188 Participants
|
189 Participants
|
193 Participants
|
|
Number of Participants With Seroconversion for Anti-HPV Neutralizing Antibodies
HPV 52 type antigen, Month 7
|
120 Participants
|
111 Participants
|
118 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Month 2, Month 3 and Month 7Population: Analysis was performed on a subset of participants from Per Protocol Set for analysis of immunogenicity, which included participants with both concentration and titer values available for the specified analysis at the specified time points. Participants with values below the LLOQ or above ULOQ in either assay were excluded from the analysis.
The Pearson coefficient of correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers was calculated for each study group and for each antigen. The Pearson correlation was computed by the log10-transformation of specific antibody concentrations.
Outcome measures
| Measure |
HPV9 High Group
n=211 Participants
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=223 Participants
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=213 Participants
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=225 Participants
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 6 type antigen, Day 1
|
0.850 Correlation coefficient
|
0.818 Correlation coefficient
|
0.756 Correlation coefficient
|
0.830 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 6 type antigen, Month 2
|
0.824 Correlation coefficient
|
0.851 Correlation coefficient
|
0.766 Correlation coefficient
|
0.786 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 6 type antigen, Month 3
|
0.813 Correlation coefficient
|
0.790 Correlation coefficient
|
0.789 Correlation coefficient
|
0.867 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 6 type antigen, Month 7
|
0.820 Correlation coefficient
|
0.810 Correlation coefficient
|
0.786 Correlation coefficient
|
0.892 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 11 type antigen, Day 1
|
0.907 Correlation coefficient
|
0.921 Correlation coefficient
|
0.951 Correlation coefficient
|
0.932 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 11 type antigen, Month 2
|
0.840 Correlation coefficient
|
0.831 Correlation coefficient
|
0.807 Correlation coefficient
|
0.820 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 11 type antigen, Month 3
|
0.806 Correlation coefficient
|
0.808 Correlation coefficient
|
0.820 Correlation coefficient
|
0.856 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 11 type antigen, Month 7
|
0.659 Correlation coefficient
|
0.839 Correlation coefficient
|
0.787 Correlation coefficient
|
0.820 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 16 type antigen, Day 1
|
0.934 Correlation coefficient
|
0.927 Correlation coefficient
|
0.918 Correlation coefficient
|
0.951 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 16 type antigen, Month 2
|
0.965 Correlation coefficient
|
0.951 Correlation coefficient
|
0.880 Correlation coefficient
|
0.958 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 16 type antigen, Month 3
|
0.871 Correlation coefficient
|
0.862 Correlation coefficient
|
0.827 Correlation coefficient
|
0.904 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 16 type antigen, Month 7
|
0.866 Correlation coefficient
|
0.893 Correlation coefficient
|
0.894 Correlation coefficient
|
0.894 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 18 type antigen, Day 1
|
0.903 Correlation coefficient
|
0.863 Correlation coefficient
|
0.896 Correlation coefficient
|
0.920 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 18 type antigen, Month 2
|
0.885 Correlation coefficient
|
0.885 Correlation coefficient
|
0.811 Correlation coefficient
|
0.866 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 18 type antigen, Month 3
|
0.881 Correlation coefficient
|
0.880 Correlation coefficient
|
0.860 Correlation coefficient
|
0.884 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 18 type antigen, Month 7
|
0.899 Correlation coefficient
|
0.871 Correlation coefficient
|
0.881 Correlation coefficient
|
0.905 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 31 type antigen, Day 1
|
0.751 Correlation coefficient
|
0.811 Correlation coefficient
|
0.708 Correlation coefficient
|
0.344 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 31 type antigen, Month 2
|
0.768 Correlation coefficient
|
0.820 Correlation coefficient
|
0.824 Correlation coefficient
|
0.745 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 31 type antigen, Month 3
|
0.800 Correlation coefficient
|
0.800 Correlation coefficient
|
0.798 Correlation coefficient
|
0.845 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 31 type antigen, Month 7
|
0.814 Correlation coefficient
|
0.824 Correlation coefficient
|
0.806 Correlation coefficient
|
0.842 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 33 type antigen, Day 1
|
0.664 Correlation coefficient
|
0.843 Correlation coefficient
|
0.831 Correlation coefficient
|
0.886 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 33 type antigen, Month 2
|
0.794 Correlation coefficient
|
0.790 Correlation coefficient
|
0.672 Correlation coefficient
|
0.711 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 33 type antigen, Month 3
|
0.811 Correlation coefficient
|
0.767 Correlation coefficient
|
0.783 Correlation coefficient
|
0.859 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 33 type antigen, Month 7
|
0.649 Correlation coefficient
|
0.807 Correlation coefficient
|
0.789 Correlation coefficient
|
0.768 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 45 type antigen, Day 1
|
0.721 Correlation coefficient
|
0.885 Correlation coefficient
|
0.692 Correlation coefficient
|
0.557 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 45 type antigen, Month 2
|
0.834 Correlation coefficient
|
0.859 Correlation coefficient
|
0.740 Correlation coefficient
|
0.805 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 45 type antigen, Month 3
|
0.846 Correlation coefficient
|
0.863 Correlation coefficient
|
0.799 Correlation coefficient
|
0.882 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 45 type antigen, Month 7
|
0.869 Correlation coefficient
|
0.870 Correlation coefficient
|
0.737 Correlation coefficient
|
0.882 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 52 type antigen, Day 1
|
0.809 Correlation coefficient
|
0.790 Correlation coefficient
|
0.847 Correlation coefficient
|
0.804 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 52 type antigen, Month 2
|
0.748 Correlation coefficient
|
0.832 Correlation coefficient
|
0.606 Correlation coefficient
|
0.767 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 52 type antigen, Month 3
|
0.797 Correlation coefficient
|
0.821 Correlation coefficient
|
0.754 Correlation coefficient
|
0.861 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 52 type antigen, Month 7
|
0.777 Correlation coefficient
|
0.834 Correlation coefficient
|
0.829 Correlation coefficient
|
0.831 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 58 type antigen, Day 1
|
0.632 Correlation coefficient
|
0.816 Correlation coefficient
|
0.791 Correlation coefficient
|
0.831 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 58 type antigen, Month 2
|
0.666 Correlation coefficient
|
0.733 Correlation coefficient
|
0.666 Correlation coefficient
|
0.803 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 58 type antigen, Month 3
|
0.831 Correlation coefficient
|
0.721 Correlation coefficient
|
0.789 Correlation coefficient
|
0.852 Correlation coefficient
|
|
Correlation Between Anti-HPV IgG Antibody Concentration and Anti-HPV Neutralizing Antibody Titers
HPV 58 type antigen, Month 7
|
0.851 Correlation coefficient
|
0.860 Correlation coefficient
|
0.825 Correlation coefficient
|
0.851 Correlation coefficient
|
Adverse Events
HPV9 High Group
Serious events: 1 serious events
Other events: 260 other events
Deaths: 0 deaths
HPV9 Med Group
Serious events: 4 serious events
Other events: 265 other events
Deaths: 0 deaths
HPV9 Low Group
Serious events: 2 serious events
Other events: 262 other events
Deaths: 0 deaths
Gar9 Group
Serious events: 7 serious events
Other events: 254 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HPV9 High Group
n=270 participants at risk
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 participants at risk
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 participants at risk
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 participants at risk
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Personality disorder
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Surgical and medical procedures
Nasal septal operation
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
Other adverse events
| Measure |
HPV9 High Group
n=270 participants at risk
Participants received 3 doses of the high formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Med Group
n=270 participants at risk
Participants received 3 doses of the medium formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
HPV9 Low Group
n=269 participants at risk
Participants received 3 doses of the low formulation of Human Papilloma Virus 9-valent (HPV9) investigational adjuvanted vaccine at Day 1, Month 2, and Month 6.
|
Gar9 Group
n=270 participants at risk
Participants received 3 doses of the marketed Human Papilloma Virus (HPV) vaccine (Gardasil 9) at Day 1, Month 2, and Month 6.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Chills
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Fatigue
|
78.9%
213/270 • Number of events 458 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
75.9%
205/270 • Number of events 402 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
71.4%
192/269 • Number of events 373 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
71.1%
192/270 • Number of events 379 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/269 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Ear and labyrinth disorders
Ear inflammation
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Endocrine disorders
Polycystic ovarian syndrome
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Eye disorders
Chalazion
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/269 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
3.3%
9/270 • Number of events 10 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/269 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Anal fissure
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Induration
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
4/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
2.2%
6/270 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/269 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
12/270 • Number of events 14 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
5.6%
15/269 • Number of events 21 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
2.6%
7/270 • Number of events 7 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Toothache
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Administration site erythema
|
46.7%
126/270 • Number of events 211 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
48.5%
131/270 • Number of events 217 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
51.7%
139/269 • Number of events 224 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
33.0%
89/270 • Number of events 130 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Administration site pain
|
94.4%
255/270 • Number of events 636 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
97.0%
262/270 • Number of events 656 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
95.2%
256/269 • Number of events 654 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
87.0%
235/270 • Number of events 528 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Administration site swelling
|
41.9%
113/270 • Number of events 188 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
36.7%
99/270 • Number of events 161 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
39.4%
106/269 • Number of events 183 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
21.9%
59/270 • Number of events 80 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Asthenia
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Axillary pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Chest pain
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Influenza like illness
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.5%
4/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site bruising
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site granuloma
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site haematoma
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site induration
|
1.5%
4/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site mass
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site nodule
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site pain
|
0.74%
2/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site pruritus
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Injection site reaction
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Malaise
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Peripheral swelling
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Pyrexia
|
12.6%
34/270 • Number of events 38 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
13.7%
37/270 • Number of events 37 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
9.3%
25/269 • Number of events 31 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
12.2%
33/270 • Number of events 37 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Swelling
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Thirst
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Vaccination site bruising
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Vaccination site induration
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.5%
4/269 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Vaccination site nodule
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Vaccination site pain
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Vaccination site pruritus
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Vaccination site swelling
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Immune system disorders
Drug hypersensitivity
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Immune system disorders
Hypersensitivity
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Bacterial vaginosis
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Bronchitis
|
1.5%
4/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Chronic sinusitis
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
COVID-19
|
2.2%
6/270 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
2.6%
7/270 • Number of events 7 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Cystitis
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
3.3%
9/270 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Fungal infection
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Genitourinary tract infection
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Helicobacter infection
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Impetigo
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Influenza
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Lyme disease
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
10/270 • Number of events 11 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
3.7%
10/269 • Number of events 11 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
2.2%
6/270 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Oral herpes
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Pharyngitis
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Respiratory tract infection
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.5%
4/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Rhinitis
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.5%
4/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
2.2%
6/269 • Number of events 6 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Tonsillitis
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Tracheitis
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
17/270 • Number of events 17 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
4.1%
11/270 • Number of events 11 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
4.1%
11/269 • Number of events 15 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
5.6%
15/270 • Number of events 16 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Vaginal infection
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Viral infection
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Investigations
Blood prolactin increased
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Investigations
Body temperature decreased
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Investigations
Human papilloma virus test positive
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Investigations
Platelet count increased
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.4%
55/270 • Number of events 75 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
16.3%
44/270 • Number of events 60 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
17.5%
47/269 • Number of events 65 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
16.7%
45/270 • Number of events 56 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.5%
4/269 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/270 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.7%
137/270 • Number of events 228 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
49.3%
133/270 • Number of events 231 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
46.8%
126/269 • Number of events 213 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
43.7%
118/270 • Number of events 178 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Dizziness
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/269 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.5%
4/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Dizziness postural
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Headache
|
71.9%
194/270 • Number of events 384 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
66.7%
180/270 • Number of events 319 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
69.5%
187/269 • Number of events 354 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
66.3%
179/270 • Number of events 337 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Migraine
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.9%
5/269 • Number of events 5 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Neuralgia
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/269 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Presyncope
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Syncope
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Tension headache
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Nervous system disorders
Thoracic radiculopathy
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Affective disorder
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Anxiety
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Bipolar disorder
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Depression
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Psychiatric disorders
Sleep disorder
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.8%
13/270 • Number of events 13 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
4.1%
11/270 • Number of events 14 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
4.1%
11/269 • Number of events 17 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
3.3%
9/270 • Number of events 9 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Reproductive system and breast disorders
Uterine pain
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/269 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.5%
4/270 • Number of events 4 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.74%
2/270 • Number of events 2 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
1.1%
3/270 • Number of events 3 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Vascular disorders
Haematoma
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Vascular disorders
Hot flush
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
Vascular disorders
Hypertension
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.37%
1/269 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
|
General disorders
Other symptoms/illnesses or reactions
|
0.37%
1/270 • Number of events 1 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/269 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
0.00%
0/270 • Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All-cause mortality, SAEs and pIMDs: from first vaccination (Day 1) up to study end (Month 12).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER