Trial Outcomes & Findings for A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years (NCT NCT01830855)
NCT ID: NCT01830855
Last Updated: 2016-06-14
Results Overview
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3596 participants
Primary outcome timeframe
One month after third bivalent rLP2086 vaccination
Results posted on
2016-06-14
Participant Flow
A total of 3596 participants were randomized in this study, out of which 3590 participants received vaccination.
Participant milestones
| Measure |
Group 1 rLP2086 Lot 1
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
Group 4 HAV/Saline
Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1508
|
598
|
587
|
897
|
|
Overall Study
COMPLETED
|
1353
|
537
|
521
|
815
|
|
Overall Study
NOT COMPLETED
|
155
|
61
|
66
|
82
|
Reasons for withdrawal
| Measure |
Group 1 rLP2086 Lot 1
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
Group 4 HAV/Saline
Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
|
|---|---|---|---|---|
|
Overall Study
Other
|
7
|
1
|
4
|
4
|
|
Overall Study
Medication error without associated AE
|
1
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
3
|
1
|
2
|
1
|
|
Overall Study
No longer meets eligibility criteria
|
11
|
2
|
3
|
5
|
|
Overall Study
Adverse Event
|
11
|
5
|
6
|
3
|
|
Overall Study
Protocol deviation
|
10
|
5
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
33
|
14
|
10
|
12
|
|
Overall Study
No longer willing to participate
|
32
|
13
|
12
|
17
|
|
Overall Study
Lost to Follow-up
|
47
|
20
|
23
|
33
|
Baseline Characteristics
A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
Baseline characteristics by cohort
| Measure |
Group 1 rLP2086 Lot 1
n=1508 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=598 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=587 Participants
Lot 3 on a 0-, 2-, 6- month schedule
|
Group 4 HAV/Saline
n=897 Participants
Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
|
Total
n=3590 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.9 Years
STANDARD_DEVIATION 2.6 • n=93 Participants
|
14.0 Years
STANDARD_DEVIATION 2.6 • n=4 Participants
|
13.9 Years
STANDARD_DEVIATION 2.6 • n=27 Participants
|
13.9 Years
STANDARD_DEVIATION 2.6 • n=483 Participants
|
13.9 Years
STANDARD_DEVIATION 2.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
737 Participants
n=93 Participants
|
286 Participants
n=4 Participants
|
274 Participants
n=27 Participants
|
443 Participants
n=483 Participants
|
1740 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
771 Participants
n=93 Participants
|
312 Participants
n=4 Participants
|
313 Participants
n=27 Participants
|
454 Participants
n=483 Participants
|
1850 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: One month after third bivalent rLP2086 vaccinationPopulation: Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
Composite hSBA response (N= 1170)
|
83.5 percentage of participants
Interval 81.3 to 85.6
|
—
|
—
|
|
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
PMB80[A22] (N= 1225)
|
83.2 percentage of participants
Interval 81.0 to 85.2
|
—
|
—
|
|
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
PMB2001[A56] (N= 1128)
|
90.2 percentage of participants
Interval 88.4 to 91.9
|
—
|
—
|
|
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
PMB2948[B24] (N= 1235)
|
79.8 percentage of participants
Interval 77.4 to 82.0
|
—
|
—
|
|
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
PMB2707[B44] (N= 1203)
|
85.9 percentage of participants
Interval 83.8 to 87.8
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after third bivalent rLP2086 vaccinationPopulation: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=519 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=493 Participants
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine
PMB80[A22] (N= 1266, 518, 492)
|
86.8 titer
Interval 82.29 to 91.5
|
84.3 titer
Interval 77.54 to 91.68
|
85.1 titer
Interval 78.26 to 92.47
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine
PMB2948[B24] (N= 1250, 516, 479)
|
24.1 titer
Interval 22.7 to 25.48
|
25.3 titer
Interval 23.08 to 27.72
|
25.2 titer
Interval 23.03 to 27.58
|
PRIMARY outcome
Timeframe: Within 7 Days after first vaccinationPopulation: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination. Here,number of participants analyzed signifies participants with known values after the first vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2681 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=890 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Severe
|
1.9 percentage of participants
Interval 1.4 to 2.5
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Any
|
86.7 percentage of participants
Interval 85.4 to 88.0
|
47.0 percentage of participants
Interval 43.6 to 50.3
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Mild
|
41.1 percentage of participants
Interval 39.2 to 43.0
|
36.5 percentage of participants
Interval 33.3 to 39.8
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Moderate
|
40.7 percentage of participants
Interval 38.8 to 42.5
|
9.9 percentage of participants
Interval 8.0 to 12.0
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Severe
|
5.0 percentage of participants
Interval 4.2 to 5.9
|
0.6 percentage of participants
Interval 0.2 to 1.3
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Any
|
16.2 percentage of participants
Interval 14.8 to 17.7
|
1.3 percentage of participants
Interval 0.7 to 2.3
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Mild
|
5.6 percentage of participants
Interval 4.7 to 6.5
|
1.2 percentage of participants
Interval 0.6 to 2.2
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Moderate
|
8.8 percentage of participants
Interval 7.7 to 9.9
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Any
|
18.0 percentage of participants
Interval 16.5 to 19.5
|
2.2 percentage of participants
Interval 1.4 to 3.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Mild
|
8.5 percentage of participants
Interval 7.4 to 9.6
|
1.8 percentage of participants
Interval 1.0 to 2.9
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Moderate
|
8.8 percentage of participants
Interval 7.7 to 9.9
|
0.4 percentage of participants
Interval 0.1 to 1.1
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Severe
|
0.7 percentage of participants
Interval 0.5 to 1.1
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after second vaccinationPopulation: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2545 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=843 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Any
|
77.7 percentage of participants
Interval 76.0 to 79.3
|
15.2 percentage of participants
Interval 12.8 to 17.8
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Mild
|
39.4 percentage of participants
Interval 37.5 to 41.3
|
12.3 percentage of participants
Interval 10.2 to 14.7
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Moderate
|
33.2 percentage of participants
Interval 31.4 to 35.1
|
2.7 percentage of participants
Interval 1.7 to 4.1
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Severe
|
5.1 percentage of participants
Interval 4.2 to 6.0
|
0.1 percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Any
|
12.5 percentage of participants
Interval 11.2 to 13.8
|
0.6 percentage of participants
Interval 0.2 to 1.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Mild
|
5.2 percentage of participants
Interval 4.4 to 6.2
|
0.6 percentage of participants
Interval 0.2 to 1.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Moderate
|
6.1 percentage of participants
Interval 5.2 to 7.1
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Severe
|
1.1 percentage of participants
Interval 0.8 to 1.6
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Any
|
13.9 percentage of participants
Interval 12.5 to 15.3
|
0.6 percentage of participants
Interval 0.2 to 1.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Mild
|
6.3 percentage of participants
Interval 5.4 to 7.3
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Moderate
|
7.3 percentage of participants
Interval 6.4 to 8.4
|
0.1 percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Severe
|
0.2 percentage of participants
Interval 0.1 to 0.5
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after third vaccinationPopulation: Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.Here,number of participants analyzed signifies participants with known values after third vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2421 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=821 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Any
|
76.0 percentage of participants
Interval 74.2 to 77.7
|
34.0 percentage of participants
Interval 30.7 to 37.3
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Mild
|
34.1 percentage of participants
Interval 32.2 to 36.0
|
23.8 percentage of participants
Interval 20.9 to 26.8
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Moderate
|
36.5 percentage of participants
Interval 34.6 to 38.5
|
9.9 percentage of participants
Interval 7.9 to 12.1
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Severe
|
5.4 percentage of participants
Interval 4.5 to 6.4
|
0.4 percentage of participants
Interval 0.1 to 1.1
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Any
|
13.9 percentage of participants
Interval 12.5 to 15.3
|
1.1 percentage of participants
Interval 0.5 to 2.1
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Mild
|
4.9 percentage of participants
Interval 4.1 to 5.8
|
1.0 percentage of participants
Interval 0.4 to 1.9
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Moderate
|
6.8 percentage of participants
Interval 5.8 to 7.9
|
0.1 percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Severe
|
2.2 percentage of participants
Interval 1.6 to 2.9
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Any
|
15.4 percentage of participants
Interval 14.0 to 16.9
|
0.9 percentage of participants
Interval 0.3 to 1.7
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Mild
|
7.9 percentage of participants
Interval 6.8 to 9.0
|
0.7 percentage of participants
Interval 0.3 to 1.6
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Moderate
|
6.8 percentage of participants
Interval 5.8 to 7.9
|
0.1 percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Severe
|
0.7 percentage of participants
Interval 0.4 to 1.1
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after first vaccinationPopulation: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.Here,number of participants analyzed signifies participants with known values after the first vaccination.
Here, N signifies participants with known values reporting specific characteristic.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2681 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=890 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fever >=38 degrees C(N=2679, 890)
|
6.4 percentage of participants
Interval 5.5 to 7.4
|
1.9 percentage of participants
Interval 1.1 to 3.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fever 38 to <38.5 degreesC(N=2679, 890)
|
4.0 percentage of participants
Interval 3.3 to 4.8
|
1.3 percentage of participants
Interval 0.7 to 2.3
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fever 38.5 to<39 degrees C(N=2679, 890)
|
1.9 percentage of participants
Interval 1.5 to 2.5
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fever 39 to 40 degrees C(N=2679, 890)
|
0.5 percentage of participants
Interval 0.3 to 0.8
|
0.2 percentage of participants
Interval 0.0 to 0.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fever >40 degrees C(N=2679, 890)
|
0.0 percentage of participants
Interval 0.0 to 0.1
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Any(N=2681,890)
|
3.7 percentage of participants
Interval 3.0 to 4.5
|
1.9 percentage of participants
Interval 1.1 to 3.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Mild(N=2681,890)
|
2.8 percentage of participants
Interval 2.2 to 3.5
|
1.7 percentage of participants
Interval 0.9 to 2.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Moderate(N=2681,890)
|
0.9 percentage of participants
Interval 0.6 to 1.4
|
0.2 percentage of participants
Interval 0.0 to 0.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Severe(N=2681,890)
|
0.0 percentage of participants
Interval 0.0 to 0.1
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Any(N=2681,890)
|
10.6 percentage of participants
Interval 9.5 to 11.9
|
12.1 percentage of participants
Interval 10.1 to 14.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Mild(N=2681,890)
|
9.1 percentage of participants
Interval 8.0 to 10.3
|
10.9 percentage of participants
Interval 8.9 to 13.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Moderate(N=2681,890)
|
1.3 percentage of participants
Interval 0.9 to 1.8
|
1.1 percentage of participants
Interval 0.5 to 2.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Severe(N=2681,890)
|
0.3 percentage of participants
Interval 0.1 to 0.5
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Headache:Any(N=2681,890)
|
51.8 percentage of participants
Interval 49.9 to 53.8
|
37.2 percentage of participants
Interval 34.0 to 40.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Headache:Mild(N=2681,890)
|
28.7 percentage of participants
Interval 27.0 to 30.5
|
24.0 percentage of participants
Interval 21.3 to 27.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Headache:Moderate(N=2681,890)
|
21.0 percentage of participants
Interval 19.4 to 22.6
|
12.5 percentage of participants
Interval 10.4 to 14.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Headache:Severe(N=2681,890)
|
2.2 percentage of participants
Interval 1.6 to 2.8
|
0.7 percentage of participants
Interval 0.2 to 1.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fatigue:Any(N=2681,890)
|
54.0 percentage of participants
Interval 52.1 to 55.9
|
40.3 percentage of participants
Interval 37.1 to 43.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fatigue:Mild(N=2681,890)
|
27.8 percentage of participants
Interval 26.1 to 29.5
|
23.5 percentage of participants
Interval 20.7 to 26.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fatigue:Moderate(N=2681,890)
|
23.2 percentage of participants
Interval 21.6 to 24.8
|
15.2 percentage of participants
Interval 12.9 to 17.7
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fatigue:Severe(N=2681,890)
|
3.0 percentage of participants
Interval 2.4 to 3.7
|
1.7 percentage of participants
Interval 0.9 to 2.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Chills:Any(N=2681,890)
|
25.3 percentage of participants
Interval 23.7 to 27.0
|
17.2 percentage of participants
Interval 14.8 to 19.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Chills:Mild(N=2681,890)
|
16.2 percentage of participants
Interval 14.8 to 17.6
|
13.3 percentage of participants
Interval 11.1 to 15.7
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Chills:Moderate(N=2681,890)
|
8.0 percentage of participants
Interval 7.0 to 9.1
|
3.5 percentage of participants
Interval 2.4 to 4.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Chills:Severe(N=2681,890)
|
1.2 percentage of participants
Interval 0.8 to 1.7
|
0.4 percentage of participants
Interval 0.1 to 1.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Any(N=2681,890)
|
24.4 percentage of participants
Interval 22.8 to 26.1
|
19.2 percentage of participants
Interval 16.7 to 22.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Mild(N=2681,890)
|
13.2 percentage of participants
Interval 11.9 to 14.5
|
13.5 percentage of participants
Interval 11.3 to 15.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Moderate(N=2681,890)
|
10.1 percentage of participants
Interval 9.0 to 11.3
|
5.4 percentage of participants
Interval 4.0 to 7.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Severe(N=2681,890)
|
1.2 percentage of participants
Interval 0.8 to 1.6
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain:Any(N=2681,890)
|
21.9 percentage of participants
Interval 20.4 to 23.5
|
13.6 percentage of participants
Interval 11.4 to 16.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain:Mild(N=2681,890)
|
11.8 percentage of participants
Interval 10.6 to 13.1
|
8.3 percentage of participants
Interval 6.6 to 10.3
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain:Moderate(N=2681,890)
|
8.7 percentage of participants
Interval 7.7 to 9.8
|
4.6 percentage of participants
Interval 3.3 to 6.2
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain:Severe(N=2681,890)
|
1.4 percentage of participants
Interval 1.0 to 1.9
|
0.7 percentage of participants
Interval 0.2 to 1.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Antipyretic medication(N=2681,890)
|
20.7 percentage of participants
Interval 19.2 to 22.3
|
10.4 percentage of participants
Interval 8.5 to 12.6
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after second vaccinationPopulation: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.
Here, N signifies participants with known values reporting specific characteristic.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2545 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=843 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever >=38 degrees C(N=2540, 840)
|
2.0 percentage of participants
Interval 1.5 to 2.6
|
1.5 percentage of participants
Interval 0.8 to 2.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever 38 to <38.5 degreesC(N=2540, 840)
|
1.2 percentage of participants
Interval 0.8 to 1.7
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever 38.5 to<39 degrees C(N=2540, 840)
|
0.7 percentage of participants
Interval 0.4 to 1.1
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever 39 to 40 degrees C(N=2540, 840)
|
0.1 percentage of participants
Interval 0.0 to 0.3
|
0.1 percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever >40 degrees C(N=2540, 840)
|
0.0 percentage of participants
Interval 0.0 to 0.1
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Any(N=2545, 843)
|
2.2 percentage of participants
Interval 1.6 to 2.8
|
1.4 percentage of participants
Interval 0.7 to 2.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Mild(N=2545, 843)
|
1.7 percentage of participants
Interval 1.3 to 2.3
|
1.1 percentage of participants
Interval 0.5 to 2.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Moderate(N=2545, 843)
|
0.4 percentage of participants
Interval 0.2 to 0.8
|
0.4 percentage of participants
Interval 0.1 to 1.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Severe(N=2545, 843)
|
0.0 percentage of participants
Interval 0.0 to 0.1
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Any(N=2545, 843)
|
7.6 percentage of participants
Interval 6.6 to 8.7
|
9.1 percentage of participants
Interval 7.3 to 11.3
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Mild(N=2545, 843)
|
6.2 percentage of participants
Interval 5.3 to 7.2
|
7.6 percentage of participants
Interval 5.9 to 9.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Moderate(N=2545, 843)
|
1.3 percentage of participants
Interval 0.9 to 1.8
|
1.2 percentage of participants
Interval 0.6 to 2.2
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Severe(N=2545, 843)
|
0.1 percentage of participants
Interval 0.0 to 0.3
|
0.4 percentage of participants
Interval 0.1 to 1.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Headache:Any(N=2545, 843)
|
37.8 percentage of participants
Interval 35.9 to 39.8
|
28.1 percentage of participants
Interval 25.1 to 31.3
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Headache:Mild(N=2545, 843)
|
20.2 percentage of participants
Interval 18.7 to 21.8
|
15.7 percentage of participants
Interval 13.3 to 18.3
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Headache:Moderate(N=2545, 843)
|
16.0 percentage of participants
Interval 14.6 to 17.5
|
10.9 percentage of participants
Interval 8.9 to 13.2
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Headache:Severe(N=2545, 843)
|
1.7 percentage of participants
Interval 1.2 to 2.2
|
1.5 percentage of participants
Interval 0.8 to 2.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Any(N=2545, 843)
|
38.3 percentage of participants
Interval 36.4 to 40.2
|
26.3 percentage of participants
Interval 23.4 to 29.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Mild(N=2545, 843)
|
20.6 percentage of participants
Interval 19.0 to 22.2
|
13.2 percentage of participants
Interval 11.0 to 15.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Moderate(N=2545, 843)
|
15.8 percentage of participants
Interval 14.4 to 17.3
|
11.7 percentage of participants
Interval 9.6 to 14.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Severe(N=2545, 843)
|
1.9 percentage of participants
Interval 1.4 to 2.5
|
1.4 percentage of participants
Interval 0.7 to 2.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills:Any(N=2545, 843)
|
16.0 percentage of participants
Interval 14.6 to 17.4
|
10.3 percentage of participants
Interval 8.3 to 12.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills:Mild(N=2545, 843)
|
10.6 percentage of participants
Interval 9.4 to 11.9
|
8.1 percentage of participants
Interval 6.3 to 10.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills:Moderate(N=2545, 843)
|
4.8 percentage of participants
Interval 4.0 to 5.7
|
1.8 percentage of participants
Interval 1.0 to 2.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills:Severe(N=2545, 843)
|
0.6 percentage of participants
Interval 0.3 to 1.0
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Any(N=2545, 843)
|
17.8 percentage of participants
Interval 16.3 to 19.3
|
10.3 percentage of participants
Interval 8.3 to 12.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Mild(N=2545, 843)
|
8.7 percentage of participants
Interval 7.6 to 9.8
|
5.2 percentage of participants
Interval 3.8 to 6.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Moderate(N=2545, 843)
|
7.9 percentage of participants
Interval 6.8 to 9.0
|
4.5 percentage of participants
Interval 3.2 to 6.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Severe(N=2545, 843)
|
1.2 percentage of participants
Interval 0.8 to 1.7
|
0.6 percentage of participants
Interval 0.2 to 1.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Joint pain:Any(N=2545, 843)
|
16.7 percentage of participants
Interval 15.3 to 18.2
|
9.1 percentage of participants
Interval 7.3 to 11.3
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Joint pain:Mild(N=2545, 843)
|
8.4 percentage of participants
Interval 7.4 to 9.6
|
5.0 percentage of participants
Interval 3.6 to 6.7
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Joint pain:Moderate(N=2545, 843)
|
7.5 percentage of participants
Interval 6.5 to 8.6
|
3.4 percentage of participants
Interval 2.3 to 4.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Joint pain:Severe(N=2545, 843)
|
0.8 percentage of participants
Interval 0.5 to 1.2
|
0.7 percentage of participants
Interval 0.3 to 1.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Antipyretic medication(N=2545, 843)
|
13.6 percentage of participants
Interval 12.3 to 15.0
|
8.9 percentage of participants
Interval 7.1 to 11.0
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days after third vaccinationPopulation: Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, number of participants analyzed signifies participants with known values after third vaccination.
Here, N signifies participants with known values reporting specific characteristic.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2421 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=821 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever >=38 degrees C(N=2414, 819)
|
2.7 percentage of participants
Interval 2.1 to 3.4
|
2.3 percentage of participants
Interval 1.4 to 3.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever 38 to <38.5degreesC(N=2414, 819)
|
1.8 percentage of participants
Interval 1.3 to 2.4
|
1.3 percentage of participants
Interval 0.7 to 2.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever 38.5 to<39 degrees C(N=2414, 819)
|
0.6 percentage of participants
Interval 0.3 to 1.0
|
0.4 percentage of participants
Interval 0.1 to 1.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever 39 to 40 degrees C(N=2414, 819)
|
0.3 percentage of participants
Interval 0.1 to 0.6
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever >40 degrees C(N=2414, 819)
|
0.0 percentage of participants
Interval 0.0 to 0.2
|
0.1 percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Any(N=2421, 821)
|
1.7 percentage of participants
Interval 1.3 to 2.3
|
2.2 percentage of participants
Interval 1.3 to 3.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Mild(N=2421, 821)
|
1.4 percentage of participants
Interval 1.0 to 2.0
|
1.7 percentage of participants
Interval 0.9 to 2.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Moderate(N=2421, 821)
|
0.3 percentage of participants
Interval 0.1 to 0.6
|
0.5 percentage of participants
Interval 0.1 to 1.2
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Severe(N=2421, 821)
|
0.0 percentage of participants
Interval 0.0 to 0.2
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Any(N=2421, 821)
|
7.7 percentage of participants
Interval 6.7 to 8.9
|
7.6 percentage of participants
Interval 5.8 to 9.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Mild(N=2421, 821)
|
6.4 percentage of participants
Interval 5.5 to 7.5
|
6.2 percentage of participants
Interval 4.7 to 8.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Moderate(N=2421, 821)
|
1.0 percentage of participants
Interval 0.6 to 1.5
|
1.1 percentage of participants
Interval 0.5 to 2.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Severe(N=2421, 821)
|
0.3 percentage of participants
Interval 0.1 to 0.6
|
0.2 percentage of participants
Interval 0.0 to 0.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Any(N=2421, 821)
|
35.4 percentage of participants
Interval 33.5 to 37.4
|
24.8 percentage of participants
Interval 21.9 to 28.0
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Mild(N=2421, 821)
|
18.9 percentage of participants
Interval 17.3 to 20.5
|
13.5 percentage of participants
Interval 11.3 to 16.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Moderate(N=2421, 821)
|
15.2 percentage of participants
Interval 13.8 to 16.7
|
10.4 percentage of participants
Interval 8.4 to 12.6
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Severe(N=2421, 821)
|
1.3 percentage of participants
Interval 0.9 to 1.9
|
1.0 percentage of participants
Interval 0.4 to 1.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Any(N=2421, 821)
|
35.9 percentage of participants
Interval 34.0 to 37.9
|
24.4 percentage of participants
Interval 21.5 to 27.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Mild(N=2421, 821)
|
18.4 percentage of participants
Interval 16.9 to 20.0
|
13.5 percentage of participants
Interval 11.3 to 16.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Moderate(N=2421, 821)
|
15.2 percentage of participants
Interval 13.8 to 16.7
|
10.0 percentage of participants
Interval 8.0 to 12.2
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Severe(N=2421, 821)
|
2.3 percentage of participants
Interval 1.8 to 3.0
|
0.9 percentage of participants
Interval 0.3 to 1.7
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills:Any(N=2421, 821)
|
13.1 percentage of participants
Interval 11.7 to 14.5
|
8.3 percentage of participants
Interval 6.5 to 10.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills:Mild(N=2421, 821)
|
8.7 percentage of participants
Interval 7.6 to 9.9
|
6.5 percentage of participants
Interval 4.9 to 8.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills:Moderate(N=2421, 821)
|
3.8 percentage of participants
Interval 3.1 to 4.7
|
1.7 percentage of participants
Interval 0.9 to 2.8
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills:Severe(N=2421, 821)
|
0.5 percentage of participants
Interval 0.3 to 0.9
|
0.1 percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Any(N=2421, 821)
|
17.6 percentage of participants
Interval 16.1 to 19.1
|
11.1 percentage of participants
Interval 9.0 to 13.4
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Mild(N=2421, 821)
|
9.5 percentage of participants
Interval 8.4 to 10.8
|
6.6 percentage of participants
Interval 5.0 to 8.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Moderate(N=2421, 821)
|
7.2 percentage of participants
Interval 6.2 to 8.3
|
4.3 percentage of participants
Interval 3.0 to 5.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Severe(N=2421, 821)
|
0.8 percentage of participants
Interval 0.5 to 1.3
|
0.2 percentage of participants
Interval 0.0 to 0.9
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Joint pain:Any(N=2421, 821)
|
16.0 percentage of participants
Interval 14.6 to 17.5
|
8.9 percentage of participants
Interval 7.0 to 11.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Joint pain:Mild(N=2421, 821)
|
8.9 percentage of participants
Interval 7.8 to 10.1
|
5.5 percentage of participants
Interval 4.0 to 7.3
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Joint pain:Moderate(N=2421, 821)
|
5.9 percentage of participants
Interval 5.0 to 6.9
|
3.0 percentage of participants
Interval 2.0 to 4.5
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Joint pain:Severe(N=2421, 821)
|
1.2 percentage of participants
Interval 0.8 to 1.8
|
0.4 percentage of participants
Interval 0.1 to 1.1
|
—
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Antipyretic medication(N=2421, 821)
|
12.7 percentage of participants
Interval 11.4 to 14.1
|
6.8 percentage of participants
Interval 5.2 to 8.8
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after first vaccinationPopulation: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
|
0.26 percentage of participants
Interval 0.1 to 0.5
|
0.33 percentage of participants
Interval 0.1 to 1.0
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after second vaccinationPopulation: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2570 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=860 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
|
0.23 percentage of participants
Interval 0.1 to 0.5
|
0.23 percentage of participants
Interval 0.0 to 0.8
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after third vaccinationPopulation: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2462 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=835 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
|
0.32 percentage of participants
Interval 0.1 to 0.6
|
0.36 percentage of participants
Interval 0.1 to 1.0
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after any vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
|
0.78 percentage of participants
Interval 0.5 to 1.2
|
0.89 percentage of participants
Interval 0.4 to 1.7
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 1 month after the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
|
1.49 percentage of participants
Interval 1.1 to 2.0
|
1.90 percentage of participants
Interval 1.1 to 3.0
|
—
|
PRIMARY outcome
Timeframe: From 1 month after third vaccination up to 6 months after the third vaccinationPopulation: Safety population: all participants who had at least 1 dose investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2524 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=839 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase
|
0.44 percentage of participants
Interval 0.2 to 0.8
|
0.60 percentage of participants
Interval 0.2 to 1.4
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 6 month after the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
|
1.89 percentage of participants
Interval 1.4 to 2.5
|
2.45 percentage of participants
Interval 1.5 to 3.7
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after first vaccinationPopulation: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
|
5.27 percentage of participants
Interval 4.5 to 6.2
|
6.69 percentage of participants
Interval 5.1 to 8.5
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after second vaccinationPopulation: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2570 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=860 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
|
5.91 percentage of participants
Interval 5.0 to 6.9
|
6.51 percentage of participants
Interval 5.0 to 8.4
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after third vaccinationPopulation: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2462 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=835 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
|
5.81 percentage of participants
Interval 4.9 to 6.8
|
7.43 percentage of participants
Interval 5.7 to 9.4
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after any vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
|
14.18 percentage of participants
Interval 12.9 to 15.6
|
16.61 percentage of participants
Interval 14.2 to 19.2
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 1 month after the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
|
25.29 percentage of participants
Interval 23.7 to 27.0
|
27.87 percentage of participants
Interval 25.0 to 30.9
|
—
|
PRIMARY outcome
Timeframe: From 1 month after third vaccination up to 6 months after the third vaccinationPopulation: Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2524 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=839 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
|
15.61 percentage of participants
Interval 14.2 to 17.1
|
16.92 percentage of participants
Interval 14.4 to 19.6
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 6 month after the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period
|
32.38 percentage of participants
Interval 30.6 to 34.2
|
35.56 percentage of participants
Interval 32.4 to 38.8
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after first vaccinationPopulation: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination
|
0.00 percentage of participants
Interval 0.0 to 0.1
|
0.11 percentage of participants
Interval 0.0 to 0.6
|
—
|
PRIMARY outcome
Timeframe: 30 days after second vaccinationPopulation: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2570 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=860 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination
|
0.08 percentage of participants
Interval 0.0 to 0.3
|
0.12 percentage of participants
Interval 0.0 to 0.6
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after third vaccinationPopulation: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2462 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=835 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination
|
0.12 percentage of participants
Interval 0.0 to 0.4
|
0.00 percentage of participants
Interval 0.0 to 0.4
|
—
|
PRIMARY outcome
Timeframe: Within 30 Days After any VaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
|
0.19 percentage of participants
Interval 0.1 to 0.4
|
0.22 percentage of participants
Interval 0.0 to 0.8
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 1 month after the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
|
0.37 percentage of participants
Interval 0.2 to 0.7
|
0.56 percentage of participants
Interval 0.2 to 1.3
|
—
|
PRIMARY outcome
Timeframe: From 1 month after third vaccination up to 6 months after the third vaccinationPopulation: Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2524 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=839 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
|
0.20 percentage of participants
Interval 0.1 to 0.5
|
0.60 percentage of participants
Interval 0.2 to 1.4
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 6 month after the third vaccinationPopulation: Safety population included all participants who received at least 1 dose of the investigational product and had safety information available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
|
0.56 percentage of participants
Interval 0.3 to 0.9
|
1.11 percentage of participants
Interval 0.5 to 2.0
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after first vaccinationPopulation: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination
|
9.51 percentage of participants
Interval 8.4 to 10.7
|
10.70 percentage of participants
Interval 8.8 to 12.9
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after second vaccinationPopulation: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2570 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=860 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
|
11.48 percentage of participants
Interval 10.3 to 12.8
|
12.67 percentage of participants
Interval 10.5 to 15.1
|
—
|
PRIMARY outcome
Timeframe: Within 30 days after third vaccinationPopulation: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2462 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=835 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
|
9.91 percentage of participants
Interval 8.8 to 11.2
|
10.78 percentage of participants
Interval 8.8 to 13.1
|
—
|
PRIMARY outcome
Timeframe: Within 30 Days after any vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination
|
25.32 percentage of participants
Interval 23.7 to 27.0
|
26.76 percentage of participants
Interval 23.9 to 29.8
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 1 month after the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase
|
40.74 percentage of participants
Interval 38.9 to 42.6
|
43.70 percentage of participants
Interval 40.4 to 47.0
|
—
|
PRIMARY outcome
Timeframe: Within 30 minutes after first vaccinationPopulation: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2693 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=897 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination
|
0.1 percentage of participants
Interval 0.0 to 0.4
|
0.2 percentage of participants
Interval 0.0 to 0.8
|
—
|
PRIMARY outcome
Timeframe: Within 30 minutes after second vaccinationPopulation: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2570 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=860 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination
|
0.2 percentage of participants
Interval 0.0 to 0.4
|
0.1 percentage of participants
Interval 0.0 to 0.6
|
—
|
PRIMARY outcome
Timeframe: Within 30 minutes after third vaccinationPopulation: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=2462 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=835 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination
|
0.1 percentage of participants
Interval 0.0 to 0.3
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
—
|
PRIMARY outcome
Timeframe: From the first vaccination up to 1 month after the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=539 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=195 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase
|
3.9 days
Standard Deviation 6.56
|
4.0 days
Standard Deviation 5.19
|
—
|
SECONDARY outcome
Timeframe: Before first vaccination, 1 month after third vaccinationPopulation: Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=300 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB3175[A29]:Before Vaccination 1 (N= 269)
|
17.5 percentage of participants
Interval 13.1 to 22.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB3175[A29]:1 Month after Vaccination 3 (N= 278)
|
98.6 percentage of participants
Interval 96.4 to 99.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB3010[A06]:Before Vaccination 1 (N= 277)
|
9.4 percentage of participants
Interval 6.2 to 13.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB3010[A06]:1 Month after Vaccination 3 (N= 280)
|
95.7 percentage of participants
Interval 92.6 to 97.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB3040[A07]:Before Vaccination 1 (N= 269)
|
43.1 percentage of participants
Interval 37.1 to 49.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB3040[A07]:1 Month after Vaccination 3 (N= 280)
|
96.4 percentage of participants
Interval 93.5 to 98.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB824[A12]: Before Vaccination 1 (N= 280)
|
3.9 percentage of participants
Interval 2.0 to 6.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB824[A12]:1 Month after Vaccination 3 (N= 277)
|
75.1 percentage of participants
Interval 69.6 to 80.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB1672[A15]:Before Vaccination 1 (N= 270)
|
20.7 percentage of participants
Interval 16.1 to 26.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB1672[A15]:1 Month after Vaccination 3 (N= 266)
|
87.2 percentage of participants
Interval 82.6 to 91.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB1989[A19]:Before Vaccination 1 (N= 274)
|
11.3 percentage of participants
Interval 7.8 to 15.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB1989[A19]:1 Month after Vaccination 3 (N= 275)
|
92.7 percentage of participants
Interval 89.0 to 95.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB1256[B03]:Before Vaccination 1 (N= 280)
|
4.3 percentage of participants
Interval 2.2 to 7.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB1256[B03]:1 Month after Vaccination 3 (N= 279)
|
92.5 percentage of participants
Interval 88.7 to 95.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB866[B09]:Before Vaccination 1 (N= 277)
|
15.2 percentage of participants
Interval 11.2 to 19.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB866[B09]:1 Month after Vaccination 3 (N= 276)
|
86.2 percentage of participants
Interval 81.6 to 90.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB431[B15]:Before Vaccination 1 (N= 275)
|
28.7 percentage of participants
Interval 23.5 to 34.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB431[B15]:1 Month after Vaccination 3 (N= 281)
|
98.2 percentage of participants
Interval 95.9 to 99.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB648[B16]:Before Vaccination 1 (N= 276)
|
7.6 percentage of participants
Interval 4.8 to 11.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
PMB648[B16]:1 Month after Vaccination 3 (N= 278)
|
81.7 percentage of participants
Interval 76.6 to 86.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Before first vaccination, 1 month after third vaccination (Vac)Population: Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=300 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3175[A29] 1:4 (N=269)
|
19.0 percentage of participants
Interval 14.5 to 24.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3175[A29] 1:4 (N=278)
|
98.6 percentage of participants
Interval 96.4 to 99.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3175[A29] 1:8 (N=269)
|
17.5 percentage of participants
Interval 13.1 to 22.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3175[A29] 1:8 (N=278)
|
98.6 percentage of participants
Interval 96.4 to 99.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3175[A29] 1:16 (N=269)
|
16.7 percentage of participants
Interval 12.5 to 21.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3175[A29] 1:16 (N=278)
|
98.6 percentage of participants
Interval 96.4 to 99.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3175[A29] 1:32 (N=269)
|
10.8 percentage of participants
Interval 7.3 to 15.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3175[A29] 1:32 (N=278)
|
97.5 percentage of participants
Interval 94.9 to 99.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3175[A29] 1:64 (N=269)
|
4.8 percentage of participants
Interval 2.6 to 8.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3175[A29] 1:64 (N=278)
|
86.0 percentage of participants
Interval 81.3 to 89.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3175[A29] 1:128 (N=269)
|
1.1 percentage of participants
Interval 0.2 to 3.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3175[A29] 1:128 (N=278)
|
52.2 percentage of participants
Interval 46.1 to 58.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3010[A06] 1:4 (N=277)
|
9.7 percentage of participants
Interval 6.5 to 13.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3010[A06] 1:4 (N=280)
|
96.1 percentage of participants
Interval 93.1 to 98.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3010[A06] 1:8 (N=277)
|
9.7 percentage of participants
Interval 6.5 to 13.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3010[A06] 1:8 (N=280)
|
96.1 percentage of participants
Interval 93.1 to 98.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3010[A06] 1:16 (N=277)
|
9.4 percentage of participants
Interval 6.2 to 13.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3010[A06] 1:16 (N=280)
|
95.7 percentage of participants
Interval 92.6 to 97.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3010[A06] 1:32 (N=277)
|
6.1 percentage of participants
Interval 3.6 to 9.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3010 [A06] 1:32 (N=280)
|
93.6 percentage of participants
Interval 90.0 to 96.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3010[A06] 1:64 (N=277)
|
2.9 percentage of participants
Interval 1.3 to 5.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3010[A06] 1:64 (N=280)
|
78.2 percentage of participants
Interval 72.9 to 82.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3010[A06] 1:128 (N=277)
|
1.4 percentage of participants
Interval 0.4 to 3.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3010[A06] 1:128 (N=280)
|
44.3 percentage of participants
Interval 38.4 to 50.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3040[A07] 1:4 (N=269)
|
43.1 percentage of participants
Interval 37.1 to 49.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3040[A07] 1:4 (N=280)
|
96.4 percentage of participants
Interval 93.5 to 98.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3040[A07] 1:8 (N=269)
|
43.1 percentage of participants
Interval 37.1 to 49.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3040[A07] 1:8 (N=280)
|
96.4 percentage of participants
Interval 93.5 to 98.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3040[A07] 1:16 (N=269)
|
42.8 percentage of participants
Interval 36.8 to 48.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3040[A07] 1:16 (N=280)
|
96.4 percentage of participants
Interval 93.5 to 98.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3040[A07] 1:32 (N=269)
|
37.2 percentage of participants
Interval 31.4 to 43.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3040[A07] 1:32 (N=280)
|
93.6 percentage of participants
Interval 90.0 to 96.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3040[A07] 1:64 (N=269)
|
21.6 percentage of participants
Interval 16.8 to 27.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3040[A07] 1:64 (N=280)
|
78.2 percentage of participants
Interval 72.9 to 82.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB3040[A07] 1:128 (N=269)
|
5.6 percentage of participants
Interval 3.2 to 9.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB3040[A07] 1:128 (N=280)
|
30.4 percentage of participants
Interval 25.0 to 36.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB824[A12] 1:4 (N=280)
|
5.4 percentage of participants
Interval 3.0 to 8.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB824[A12] 1:4 (N=277)
|
77.6 percentage of participants
Interval 72.2 to 82.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB824[A12] 1:8 (N=280)
|
4.6 percentage of participants
Interval 2.5 to 7.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB824[A12] 1:8 (N=277)
|
77.3 percentage of participants
Interval 71.9 to 82.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB824[A12] 1:16 (N=280)
|
3.9 percentage of participants
Interval 2.0 to 6.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB824[A12] 1:16 (N=277)
|
75.1 percentage of participants
Interval 69.6 to 80.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB824[A12] 1:32 (N=280)
|
2.5 percentage of participants
Interval 1.0 to 5.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB824[A12] 1:32 (N=277)
|
51.3 percentage of participants
Interval 45.2 to 57.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB824[A12] 1:64 (N=280)
|
0.0 percentage of participants
Interval 0.0 to 1.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB824[A12] 1:64 (N=277)
|
19.5 percentage of participants
Interval 15.0 to 24.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB824[A12] 1:128 (N=280)
|
0.0 percentage of participants
Interval 0.0 to 1.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB824[A12] 1:128 (N=277)
|
1.8 percentage of participants
Interval 0.6 to 4.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1672[A15] 1:4 (N=270)
|
22.6 percentage of participants
Interval 17.7 to 28.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1672[A15] 1:4 (N=266)
|
87.2 percentage of participants
Interval 82.6 to 91.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1672[A15] 1:8 (N=270)
|
20.7 percentage of participants
Interval 16.1 to 26.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1672[A15] 1:8 (N=266)
|
87.2 percentage of participants
Interval 82.6 to 91.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1672[A15] 1:16 (N=270)
|
17.0 percentage of participants
Interval 12.8 to 22.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1672[A15] 1:16 (N=266)
|
85.0 percentage of participants
Interval 80.1 to 89.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1672[A15] 1:32 (N=270)
|
13.3 percentage of participants
Interval 9.5 to 18.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1672[A15] 1:32 (N=266)
|
71.4 percentage of participants
Interval 65.6 to 76.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1672[A15] 1:64 (N=270)
|
3.7 percentage of participants
Interval 1.8 to 6.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1672[A15] 1:64 (N=266)
|
40.2 percentage of participants
Interval 34.3 to 46.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1672[A15] 1:128 (N=270)
|
0.4 percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1672[A15] 1:128 (N=266)
|
10.5 percentage of participants
Interval 7.1 to 14.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1989[A19] 1:4 (N=274)
|
20.8 percentage of participants
Interval 16.2 to 26.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1989[A19] 1:4 (N=275)
|
93.8 percentage of participants
Interval 90.3 to 96.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1989[A19] 1:8 (N=274)
|
18.6 percentage of participants
Interval 14.2 to 23.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1989[A19] 1:8 (N=275)
|
93.8 percentage of participants
Interval 90.3 to 96.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1989[A19] 1:16 (N=274)
|
11.3 percentage of participants
Interval 7.8 to 15.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1989[A19] 1:16 (N=275)
|
92.7 percentage of participants
Interval 89.0 to 95.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1989[A19] 1:32 (N=274)
|
5.8 percentage of participants
Interval 3.4 to 9.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1989[A19] 1:32 (N=275)
|
85.5 percentage of participants
Interval 80.7 to 89.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1989[A19] 1:64 (N=274)
|
1.8 percentage of participants
Interval 0.6 to 4.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1989[A19] 1:64 (N=275)
|
60.0 percentage of participants
Interval 53.9 to 65.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1989[A19] 1:128 (N=274)
|
0.4 percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1989[A19] 1:128 (N=275)
|
33.1 percentage of participants
Interval 27.6 to 39.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1256[B03] 1:4 (N=280)
|
5.0 percentage of participants
Interval 2.8 to 8.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1256[B03] 1:4 (N=279)
|
92.5 percentage of participants
Interval 88.7 to 95.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1256[B03] 1:8 (N=280)
|
4.3 percentage of participants
Interval 2.2 to 7.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1256[B03] 1:8 (N=279)
|
92.5 percentage of participants
Interval 88.7 to 95.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1256[B03] 1:16 (N=280)
|
4.3 percentage of participants
Interval 2.2 to 7.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1256[B03] 1:16 (N=279)
|
92.1 percentage of participants
Interval 88.3 to 95.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1256[B03] 1:32 (N=280)
|
3.9 percentage of participants
Interval 2.0 to 6.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1256[B03] 1:32 (N=279)
|
81.4 percentage of participants
Interval 76.3 to 85.8
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1256[B03] 1:64 (N=280)
|
2.9 percentage of participants
Interval 1.2 to 5.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1256[B03] 1:64 (N=279)
|
60.6 percentage of participants
Interval 54.6 to 66.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB1256[B03] 1:128 (N=280)
|
0.4 percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB1256[B03] 1:128 (N=279)
|
29.4 percentage of participants
Interval 24.1 to 35.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB866[B09] 1:4 (N=277)
|
15.5 percentage of participants
Interval 11.5 to 20.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB866[B09] 1:4 (N=276)
|
86.6 percentage of participants
Interval 82.0 to 90.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB866[B09] 1:8 (N=277)
|
15.2 percentage of participants
Interval 11.2 to 19.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB866[B09] 1:8 (N=276)
|
86.2 percentage of participants
Interval 81.6 to 90.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB866[B09] 1:16 (N=277)
|
13.7 percentage of participants
Interval 9.9 to 18.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB866[B09] 1:16 (N=276)
|
83.7 percentage of participants
Interval 78.8 to 87.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB866[B09] 1:32 (N=277)
|
8.7 percentage of participants
Interval 5.6 to 12.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB866[B09] 1:32 (N=276)
|
54.0 percentage of participants
Interval 47.9 to 60.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB866[B09] 1:64 (N=277)
|
0.4 percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB866[B09] 1:64 (N=276)
|
21.4 percentage of participants
Interval 16.7 to 26.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB866[B09] 1:128 (N=277)
|
0.0 percentage of participants
Interval 0.0 to 1.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB866[B09] 1:128 (N=276)
|
4.3 percentage of participants
Interval 2.3 to 7.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB431[B15] 1:4 (N=275)
|
30.5 percentage of participants
Interval 25.2 to 36.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB431[B15] 1:4 (N=281)
|
98.2 percentage of participants
Interval 95.9 to 99.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB431[B15] 1:8 (N=275)
|
28.7 percentage of participants
Interval 23.5 to 34.5
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB431[B15] 1:8 (N=281)
|
98.2 percentage of participants
Interval 95.9 to 99.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB431[B15] 1:16 (N=275)
|
27.6 percentage of participants
Interval 22.4 to 33.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB431[B15] 1:16 (N=281)
|
97.5 percentage of participants
Interval 94.9 to 99.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB431[B15] 1:32 (N=275)
|
21.8 percentage of participants
Interval 17.1 to 27.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB431[B15] 1:32 (N=281)
|
85.1 percentage of participants
Interval 80.3 to 89.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB431[B15] 1:64 (N=275)
|
8.4 percentage of participants
Interval 5.4 to 12.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB431[B15] 1:64 (N=281)
|
56.2 percentage of participants
Interval 50.2 to 62.1
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB431[B15] 1:128 (N=275)
|
0.4 percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB431[B15] 1:128 (N=281)
|
19.2 percentage of participants
Interval 14.8 to 24.3
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB648[B16] 1:4 (N=276)
|
8.7 percentage of participants
Interval 5.7 to 12.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB648[B16] 1:4 (N=278)
|
82.7 percentage of participants
Interval 77.8 to 87.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB648[B16] 1:8 (N=276)
|
7.6 percentage of participants
Interval 4.8 to 11.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB648[B16] 1:8 (N=278)
|
81.7 percentage of participants
Interval 76.6 to 86.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB648[B16] 1:16 (N=276)
|
7.6 percentage of participants
Interval 4.8 to 11.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB648[B16] 1:16 (N=278)
|
79.9 percentage of participants
Interval 74.7 to 84.4
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB648[B16] 1:32 (N=276)
|
6.2 percentage of participants
Interval 3.6 to 9.7
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB648[B16] 1:32 (N=278)
|
54.0 percentage of participants
Interval 47.9 to 59.9
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB648[B16] 1:64 (N=276)
|
1.8 percentage of participants
Interval 0.6 to 4.2
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB648[B16] 1:64 (N=278)
|
24.1 percentage of participants
Interval 19.2 to 29.6
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Before Vaccination 1: PMB648[B16] 1:128 (N=276)
|
0.4 percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
1 month after Vac 3: PMB648[B16] 1:128 (N=278)
|
5.8 percentage of participants
Interval 3.3 to 9.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Before first vaccination, 1 month after third vaccinationPopulation: Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain.
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=300 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB3175[A29]:Before Vaccination 1 (N= 269)
|
5.7 titer
Interval 5.16 to 6.28
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB3175[A29]:1 Month after Vaccination 3 (N= 278)
|
93.5 titer
Interval 84.79 to 103.09
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB3010[A06]:Before Vaccination 1 (N= 277)
|
9.3 titer
Interval 8.68 to 9.91
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB3010[A06]:1 Month after Vaccination 3 (N= 280)
|
78.6 titer
Interval 70.94 to 87.08
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB3040[A07]:Before Vaccination 1 (N= 269)
|
11.4 titer
Interval 9.75 to 13.23
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB3040[A07]:1 Month after Vaccination 3 (N= 280)
|
63.5 titer
Interval 57.93 to 69.66
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB824[A12]: Before Vaccination 1 (N= 280)
|
8.4 titer
Interval 8.14 to 8.59
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB824[A12]:1 Month after Vaccination 3 (N= 277)
|
22.3 titer
Interval 20.37 to 24.45
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB1672[A15]:Before Vaccination 1 (N= 270)
|
5.9 titer
Interval 5.32 to 6.46
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB1672[A15]:1 Month after Vaccination 3 (N= 266)
|
31.0 titer
Interval 27.43 to 35.07
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB1989[A19]:Before Vaccination 1 (N= 274)
|
9.1 titer
Interval 8.7 to 9.62
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB1989[A19]:1 Month after Vaccination 3 (N= 275)
|
57.6 titer
Interval 51.3 to 64.6
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB1256[B03]:Before Vaccination 1 (N= 280)
|
4.5 titer
Interval 4.19 to 4.75
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB1256[B03]:1 Month after Vaccination 3 (N= 279)
|
51.7 titer
Interval 45.36 to 58.89
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB866[B09]:Before Vaccination 1 (N= 277)
|
5.2 titer
Interval 4.82 to 5.62
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB866[B09]:1 Month after Vaccination 3 (N= 276)
|
22.9 titer
Interval 20.48 to 25.63
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB431[B15]:Before Vaccination 1 (N= 275)
|
7.3 titer
Interval 6.49 to 8.23
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB431[B15]:1 Month after Vaccination 3 (N= 281)
|
47.7 titer
Interval 43.66 to 52.16
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB648[B16]:Before Vaccination 1 (N= 276)
|
4.7 titer
Interval 4.39 to 5.05
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
PMB648[B16]:1 Month after Vaccination 3 (N= 278)
|
22.1 titer
Interval 19.6 to 24.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination 1, 1 Month after Vaccination 2Population: Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point.
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1
Before First Vaccination (N= 1088)
|
1.1 percentage of participants
Interval 0.6 to 1.9
|
—
|
—
|
|
Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1
1 Month after Vaccination 2 (N= 1122)
|
54.1 percentage of participants
Interval 51.1 to 57.0
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after second Bivalent rLP2086 vaccinationPopulation: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1
PMB80[A22] (N=1223)
|
73.8 percentage of participants
Interval 71.2 to 76.2
|
—
|
—
|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1
PMB2001[A56] (N=1122)
|
84.8 percentage of participants
Interval 82.5 to 86.8
|
—
|
—
|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1
PMB2948[B24] (N=1201)
|
56.2 percentage of participants
Interval 53.3 to 59.0
|
—
|
—
|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1
PMB2707[B44] (N=1197)
|
55.9 percentage of participants
Interval 53.0 to 58.7
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after second, third vaccinationPopulation: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=519 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=493 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination
PMB80[A22]:1Month after Vaccination 2 (N=493, 473)
|
71.2 percentage of participants
Interval 67.0 to 75.2
|
74.6 percentage of participants
Interval 70.5 to 78.5
|
—
|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination
PMB80[A22]:1Month after Vaccination 3 (N=501, 478)
|
83.8 percentage of participants
Interval 80.3 to 86.9
|
86.0 percentage of participants
Interval 82.5 to 89.0
|
—
|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination
PMB2948[B24]:1Month after Vaccination 2(N=490,463)
|
56.7 percentage of participants
Interval 52.2 to 61.2
|
56.8 percentage of participants
Interval 52.2 to 61.4
|
—
|
|
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination
PMB2948[B24]:1Month after Vaccination 3(N=507,472)
|
76.5 percentage of participants
Interval 72.6 to 80.2
|
78.4 percentage of participants
Interval 74.4 to 82.0
|
—
|
SECONDARY outcome
Timeframe: Before vaccination (Vac) 1, 1 Month after Vac 2Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=519 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=493 Participants
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB80[A22]: Before Vac 1 (N=1238, 502, 479)
|
12.6 titer
Interval 12.08 to 13.14
|
12.9 titer
Interval 12.06 to 13.79
|
12.2 titer
Interval 11.43 to 13.04
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB80[A22]: 1 Month after Vac 2 (N=1263, 510, 487)
|
50.4 titer
Interval 47.76 to 53.09
|
47.7 titer
Interval 43.82 to 51.97
|
49.6 titer
Interval 45.58 to 53.99
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB2001[A56]: Before Vac 1 (N=1135, 0, 0)
|
8.4 titer
Interval 7.8 to 9.05
|
NA titer
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA titer
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB2001[A56]: 1 Month after Vac 2 (N=1222, 0, 0)
|
131.2 titer
Interval 124.03 to 138.7
|
NA titer
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA titer
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB2948[B24]: Before Vac 1 (N=1264, 510, 486)
|
4.5 titer
Interval 4.37 to 4.6
|
4.6 titer
Interval 4.43 to 4.85
|
4.6 titer
Interval 4.43 to 4.88
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB2948[B24]: 1 Month after Vac 2 (N=1216,499,470)
|
14.3 titer
Interval 13.45 to 15.31
|
14.5 titer
Interval 13.23 to 15.98
|
15.2 titer
Interval 13.75 to 16.85
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB2707[B44]: Before Vac 1 (N=1230, 0, 0)
|
4.3 titer
Interval 4.17 to 4.34
|
NA titer
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA titer
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
PMB2707[B44]: 1 Month after Vac 2 (N=1204, 0, 0)
|
17.1 titer
Interval 15.8 to 18.6
|
NA titer
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA titer
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
SECONDARY outcome
Timeframe: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3Population: Evaluable immunogenicity population. Here N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=519 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=493 Participants
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 monthafterVac2:PMB2948[B24]1:8(N=1216,499,470)
|
66.4 percentage of participants
Interval 63.6 to 69.0
|
70.1 percentage of participants
Interval 65.9 to 74.1
|
70.2 percentage of participants
Interval 65.9 to 74.3
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 monthafterVac3:PMB2948[B24]1:8(N=1250,516,479)
|
87.1 percentage of participants
Interval 85.1 to 88.9
|
87.6 percentage of participants
Interval 84.4 to 90.3
|
90.0 percentage of participants
Interval 86.9 to 92.5
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2707[B44] 1:8(N=1230, 0, 0)
|
3.6 percentage of participants
Interval 2.6 to 4.8
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2707[B44]1:8(N=1204, 0, 0)
|
64.0 percentage of participants
Interval 61.3 to 66.8
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2707[B44]1:8(N=1210, 0, 0)
|
89.3 percentage of participants
Interval 87.4 to 90.9
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB80[A22] 1:16(N=1238, 502, 479)
|
33.2 percentage of participants
Interval 30.6 to 35.9
|
34.9 percentage of participants
Interval 30.7 to 39.2
|
31.7 percentage of participants
Interval 27.6 to 36.1
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac2:PMB80[A22]1:16(N=1263,510,487)
|
94.3 percentage of participants
Interval 92.9 to 95.5
|
92.7 percentage of participants
Interval 90.1 to 94.8
|
94.7 percentage of participants
Interval 92.3 to 96.5
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB80[A22]1:16(N=1266, 518,492)
|
97.8 percentage of participants
Interval 96.8 to 98.5
|
97.3 percentage of participants
Interval 95.5 to 98.5
|
98.2 percentage of participants
Interval 96.6 to 99.2
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2001[A56] 1:8(N=1135, 0, 0)
|
27.5 percentage of participants
Interval 24.9 to 30.2
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2001[A56]1:8(N=1222, 0, 0)
|
99.1 percentage of participants
Interval 98.4 to 99.5
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2001[A56]1:8(N=1229, 0, 0)
|
99.5 percentage of participants
Interval 98.9 to 99.8
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2948[B24]1:8(N=1264, 510, 486)
|
6.4 percentage of participants
Interval 5.1 to 7.9
|
8.6 percentage of participants
Interval 6.3 to 11.4
|
8.4 percentage of participants
Interval 6.1 to 11.3
|
SECONDARY outcome
Timeframe: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=519 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=493 Participants
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1:PMB2707[B44] 1:128(N=1230, 0, 0)
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1:PMB80[A22] 1:4(N=1238, 502, 479)
|
36.2 percentage of participants
Interval 33.5 to 38.9
|
39.6 percentage of participants
Interval 35.3 to 44.1
|
36.7 percentage of participants
Interval 32.4 to 41.2
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB80[A22]1:4(N=1263, 510, 487)
|
94.9 percentage of participants
Interval 93.6 to 96.1
|
93.7 percentage of participants
Interval 91.3 to 95.7
|
95.5 percentage of participants
Interval 93.2 to 97.1
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB80[A22]1:4(N=1266, 518, 492)
|
97.9 percentage of participants
Interval 97.0 to 98.7
|
98.1 percentage of participants
Interval 96.5 to 99.1
|
98.4 percentage of participants
Interval 96.8 to 99.3
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB80[A22] 1:8(N=1238, 502, 479)
|
34.8 percentage of participants
Interval 32.2 to 37.5
|
39.0 percentage of participants
Interval 34.8 to 43.5
|
34.7 percentage of participants
Interval 30.4 to 39.1
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB80[A22]1:8(N=1263, 510, 487)
|
94.7 percentage of participants
Interval 93.3 to 95.9
|
93.5 percentage of participants
Interval 91.0 to 95.5
|
95.5 percentage of participants
Interval 93.2 to 97.1
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB80[A22]1:8(N=1266, 518, 492)
|
97.9 percentage of participants
Interval 97.0 to 98.7
|
98.1 percentage of participants
Interval 96.5 to 99.1
|
98.4 percentage of participants
Interval 96.8 to 99.3
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB80[A22] 1:32(N=1238, 502, 479)
|
20.9 percentage of participants
Interval 18.7 to 23.3
|
21.7 percentage of participants
Interval 18.2 to 25.6
|
19.8 percentage of participants
Interval 16.4 to 23.7
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB80[A22]1:32(N=1263, 510,487)
|
81.9 percentage of participants
Interval 79.7 to 84.0
|
79.4 percentage of participants
Interval 75.6 to 82.8
|
80.7 percentage of participants
Interval 76.9 to 84.1
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB80[A22]1:32(N=1266,518,492)
|
93.0 percentage of participants
Interval 91.4 to 94.3
|
92.1 percentage of participants
Interval 89.4 to 94.3
|
93.1 percentage of participants
Interval 90.5 to 95.2
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB80[A22] 1:64(N=1238, 502, 479)
|
8.5 percentage of participants
Interval 7.0 to 10.2
|
9.6 percentage of participants
Interval 7.1 to 12.5
|
5.4 percentage of participants
Interval 3.6 to 7.9
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB80[A22]1:64(N=1263,510,487)
|
51.8 percentage of participants
Interval 49.0 to 54.6
|
49.6 percentage of participants
Interval 45.2 to 54.0
|
51.5 percentage of participants
Interval 47.0 to 56.1
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2001[A56] 1:64(N=1135, 0, 0)
|
17.1 percentage of participants
Interval 14.9 to 19.4
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB80[A22]1:64(N=1266,518,492)
|
75.3 percentage of participants
Interval 72.8 to 77.6
|
75.5 percentage of participants
Interval 71.5 to 79.1
|
73.6 percentage of participants
Interval 69.4 to 77.4
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB80[A22] 1:128(N=1238, 502,479)
|
2.0 percentage of participants
Interval 1.3 to 3.0
|
2.0 percentage of participants
Interval 1.0 to 3.6
|
2.5 percentage of participants
Interval 1.3 to 4.3
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB80[A22]1:128(N=1263,510,487)
|
24.5 percentage of participants
Interval 22.1 to 26.9
|
23.5 percentage of participants
Interval 19.9 to 27.5
|
24.4 percentage of participants
Interval 20.7 to 28.5
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB80[A22]1:128(N=1266,518,492)
|
48.3 percentage of participants
Interval 45.6 to 51.1
|
46.3 percentage of participants
Interval 42.0 to 50.7
|
49.2 percentage of participants
Interval 44.7 to 53.7
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2001[A56] 1:4(N=1135, 0, 0)
|
29.5 percentage of participants
Interval 26.9 to 32.3
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2001[A56]1:4(N=1222, 0, 0)
|
99.1 percentage of participants
Interval 98.4 to 99.5
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2001[A56]1:4(N=1229, 0, 0)
|
99.5 percentage of participants
Interval 98.9 to 99.8
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2001[A56] 1:16(N=1135, 0, 0)
|
27.4 percentage of participants
Interval 24.8 to 30.1
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2001[A56]1:16(N=1222,0,0)
|
99.1 percentage of participants
Interval 98.4 to 99.5
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2001[A56]1:16(N=1229,0,0)
|
99.4 percentage of participants
Interval 98.8 to 99.8
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2001[A56] ] 1:32(N=1135, 0, 0)
|
25.6 percentage of participants
Interval 23.0 to 28.2
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2001[A56] 1:32(N=1222,0,0)
|
97.2 percentage of participants
Interval 96.1 to 98.1
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2001[A56]1:32(N=1229,0,0)
|
98.6 percentage of participants
Interval 97.8 to 99.2
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac2:PMB2001[A56]1:64(N=1222,0,0)
|
89.4 percentage of participants
Interval 87.6 to 91.1
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2001[A56]1:64(N=1229,0,0)
|
94.5 percentage of participants
Interval 93.0 to 95.7
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2001[A56] 1:128(N=1135, 0, 0)
|
6.4 percentage of participants
Interval 5.1 to 8.0
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2001[A56]1:128(N=1222,0,0)
|
63.4 percentage of participants
Interval 60.6 to 66.1
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac3:PMB2001[A56]1:128(N=1229,0,0)
|
82.9 percentage of participants
Interval 80.7 to 85.0
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001 \[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2948[B24] 1:4(N=1264, 510, 486)
|
6.8 percentage of participants
Interval 5.5 to 8.3
|
10.2 percentage of participants
Interval 7.7 to 13.2
|
9.5 percentage of participants
Interval 7.0 to 12.4
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2948[B24]1:4(N=1216,499,470)
|
69.2 percentage of participants
Interval 66.6 to 71.8
|
72.9 percentage of participants
Interval 68.8 to 76.8
|
74.0 percentage of participants
Interval 69.8 to 78.0
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2948[B24]1:4(N=1250,516,479)
|
88.9 percentage of participants
Interval 87.0 to 90.6
|
89.9 percentage of participants
Interval 87.0 to 92.4
|
91.6 percentage of participants
Interval 88.8 to 94.0
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2948[B24] 1:16(N=1264, 510, 486)
|
5.4 percentage of participants
Interval 4.2 to 6.8
|
7.5 percentage of participants
Interval 5.3 to 10.1
|
7.0 percentage of participants
Interval 4.9 to 9.6
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac2:PMB2948[B24]1:16(N=1216,499,470)
|
60.0 percentage of participants
Interval 57.2 to 62.8
|
61.5 percentage of participants
Interval 57.1 to 65.8
|
62.1 percentage of participants
Interval 57.6 to 66.5
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac3:PMB2948[B24]1:16(N=1250,516,479)
|
82.6 percentage of participants
Interval 80.4 to 84.7
|
81.2 percentage of participants
Interval 77.6 to 84.5
|
83.1 percentage of participants
Interval 79.4 to 86.3
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2948[B24] 1:32(N=1264, 510, 486)
|
2.8 percentage of participants
Interval 2.0 to 3.9
|
3.9 percentage of participants
Interval 2.4 to 6.0
|
3.7 percentage of participants
Interval 2.2 to 5.8
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac2:PMB2948[B24]1:32(N=1216,499,470)
|
33.0 percentage of participants
Interval 30.3 to 35.7
|
34.5 percentage of participants
Interval 30.3 to 38.8
|
35.5 percentage of participants
Interval 31.2 to 40.0
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac3:PMB2948[B24]1:32(N=1250,516,479)
|
52.1 percentage of participants
Interval 49.3 to 54.9
|
54.8 percentage of participants
Interval 50.4 to 59.2
|
54.1 percentage of participants
Interval 49.5 to 58.6
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1:PMB2948[B24] 1:64(N=1264, 510, 486)
|
1.3 percentage of participants
Interval 0.7 to 2.0
|
1.2 percentage of participants
Interval 0.4 to 2.5
|
1.9 percentage of participants
Interval 0.9 to 3.5
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 monthafterVac2:PMB2948[B24]1:64(N=1216,499,470)
|
15.3 percentage of participants
Interval 13.3 to 17.4
|
13.0 percentage of participants
Interval 10.2 to 16.3
|
15.3 percentage of participants
Interval 12.2 to 18.9
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac3:PMB2948[B24]1:64(N=1250,516,479)
|
22.8 percentage of participants
Interval 20.5 to 25.2
|
27.5 percentage of participants
Interval 23.7 to 31.6
|
25.3 percentage of participants
Interval 21.4 to 29.4
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1:PMB2948[B24] 1:128(N=1264, 510,486)
|
0.5 percentage of participants
Interval 0.2 to 1.0
|
0.2 percentage of participants
Interval 0.0 to 1.1
|
0.4 percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 monthafterVac2:PMB2948[B24]1:128(N=1216,499,470)
|
6.2 percentage of participants
Interval 4.9 to 7.7
|
5.2 percentage of participants
Interval 3.4 to 7.5
|
7.0 percentage of participants
Interval 4.9 to 9.7
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 monthafterVac3:PMB2948[B24]1:128(N=1250,516,479)
|
8.9 percentage of participants
Interval 7.4 to 10.6
|
11.2 percentage of participants
Interval 8.6 to 14.3
|
8.6 percentage of participants
Interval 6.2 to 11.4
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2707[B44] 1:4(N=1230, 0, 0)
|
4.6 percentage of participants
Interval 3.5 to 5.9
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2707[B44]1:4(N=1204, 0,0)
|
66.7 percentage of participants
Interval 64.0 to 69.4
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2707[B44]1:4(N=1210, 0,0)
|
90.4 percentage of participants
Interval 88.6 to 92.0
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2707[B44] 1:16(N=1230, 0, 0)
|
3.0 percentage of participants
Interval 2.1 to 4.1
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2707[B44]1:16(N=1204,0,0)
|
57.7 percentage of participants
Interval 54.9 to 60.5
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month afterVac3:PMB2707[B44]1:16(N=1210,0, 0)
|
86.8 percentage of participants
Interval 84.7 to 88.6
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1: PMB2707[B44] 1:32(N=1230, 0, 0)
|
1.6 percentage of participants
Interval 1.0 to 2.5
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2707[B44]1:32(N=1204,0,0)
|
39.0 percentage of participants
Interval 36.3 to 41.9
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2707[B44]1:32(N=1210,0,0)
|
71.6 percentage of participants
Interval 68.9 to 74.1
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Before Vac 1:PMB2707[B44] 1:64(N=1230, 0, 0)
|
0.7 percentage of participants
Interval 0.3 to 1.3
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2707[B44]1:64(N=1204,0,0)
|
23.3 percentage of participants
Interval 21.0 to 25.8
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2707[B44]1:64(N=1210,0,0)
|
54.5 percentage of participants
Interval 51.7 to 57.4
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac2:PMB2707[B44]1:128(N=1204,0,0)
|
13.0 percentage of participants
Interval 11.2 to 15.1
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
1 month after Vac3:PMB2707[B44]1:128(N=1210,0,0)
|
35.0 percentage of participants
Interval 32.4 to 37.8
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707 \[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
SECONDARY outcome
Timeframe: One month after third bivalent rLP2086 vaccinationPopulation: Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One month after third bivalent rLP2086 vaccination (Vac)Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
Outcome measures
| Measure |
Group 1 rLP2086 Lot 1
n=1279 Participants
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=519 Participants
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=493 Participants
Lot 3 on a 0-, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination
PMB80[A22]: 1 Month after Vac 3(N=1225, 501, 478)
|
91.43 percentage of participants
Interval 89.7 to 92.9
|
92.02 percentage of participants
Interval 89.3 to 94.2
|
93.51 percentage of participants
Interval 90.9 to 95.6
|
|
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination
PMB2001[A56]: 1 Month after Vac 3(N=1128, 0, 0)
|
95.04 percentage of participants
Interval 93.6 to 96.2
|
NA percentage of participants
PMB2001\[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2001\[A56\] was not planned to be analyzed for Group 2 and Group 3.
|
|
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination
PMB2948[B24]: 1 Month after Vac 3(N=1235, 507,472)
|
81.05 percentage of participants
Interval 78.8 to 83.2
|
79.09 percentage of participants
Interval 75.3 to 82.6
|
80.93 percentage of participants
Interval 77.1 to 84.4
|
|
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination
PMB2707[B44]: 1 Month after Vac 3(N=1203, 0, 0)
|
86.62 percentage of participants
Interval 84.6 to 88.5
|
NA percentage of participants
PMB2707\[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
NA percentage of participants
PMB2707\[B44\] was not planned to be analyzed for Group 2 and Group 3.
|
Adverse Events
Group 1 rLP2086 Lot 1
Serious events: 22 serious events
Other events: 1410 other events
Deaths: 0 deaths
Group 2 rLP2086 Lot 2
Serious events: 10 serious events
Other events: 547 other events
Deaths: 0 deaths
Group 3 rLP2086 Lot 3
Serious events: 19 serious events
Other events: 542 other events
Deaths: 0 deaths
Group 4 HAV/Saline
Serious events: 22 serious events
Other events: 655 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 rLP2086 Lot 1
n=1508 participants at risk
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=598 participants at risk
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=587 participants at risk
Lot 3 on a 0-, 2-, 6- month schedule
|
Group 4 HAV/Saline
n=897 participants at risk
Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Eye disorders
Blindness transient
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
2/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Influenza like illness
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Immune system disorders
Food allergy
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.45%
4/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.22%
2/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Abscess
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Appendiceal abscess
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Influenza
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Meningitis aseptic
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Osteomyelitis
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.13%
2/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Investigations
Heart sounds abnormal
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Nervous system disorders
Headache
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Nervous system disorders
Syncope
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Suicidal ideation
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.22%
2/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Anorexia nervosa
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.11%
1/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Renal and urinary disorders
Urinary retention
|
0.07%
1/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.00%
0/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
Other adverse events
| Measure |
Group 1 rLP2086 Lot 1
n=1508 participants at risk
Lot 1 on a 0-, 2-, 6- month schedule.
|
Group 2 rLP2086 Lot 2
n=598 participants at risk
Lot 2 on a 0-, 2-, 6- month schedule
|
Group 3 rLP2086 Lot 3
n=587 participants at risk
Lot 3 on a 0-, 2-, 6- month schedule
|
Group 4 HAV/Saline
n=897 participants at risk
Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
29/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.84%
5/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.5%
9/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.89%
8/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Diarrhea
|
0.99%
15/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.51%
3/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.7%
15/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
14/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.67%
4/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.34%
2/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.3%
12/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Gastrointestinal disorders
Nausea
|
0.66%
10/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.51%
3/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.78%
7/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Pyrexia
|
1.2%
18/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.3%
8/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.85%
5/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.89%
8/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Fatigue
|
0.33%
5/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.50%
3/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.56%
5/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
105/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
8.9%
53/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
7.7%
45/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
7.8%
70/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Pharyngitis
|
4.6%
69/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
3.5%
21/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
4.1%
24/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
4.8%
43/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
59/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
5.4%
32/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
5.5%
32/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
3.6%
32/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
43/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
4.2%
25/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
3.2%
19/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.8%
25/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Sinusitis
|
2.3%
34/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
3.2%
19/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.4%
14/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.5%
22/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Bronchitis
|
1.8%
27/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.7%
10/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.1%
19/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Otitis media
|
1.3%
19/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.8%
11/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.9%
11/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.8%
16/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.4%
21/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.7%
10/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.4%
13/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Influenza
|
1.3%
19/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.5%
9/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.4%
8/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
9/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Acute sinusitis
|
1.2%
18/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.3%
8/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.78%
7/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
18/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.84%
5/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.7%
10/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.78%
7/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Viral infection
|
0.99%
15/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.3%
8/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.68%
4/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.3%
12/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Viral pharyngitis
|
1.3%
19/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.67%
4/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.34%
2/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
9/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Tonsillitis
|
0.66%
10/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.51%
3/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.1%
10/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Otitis externa
|
0.53%
8/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.5%
9/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.51%
3/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
9/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Otitis media acute
|
0.53%
8/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.34%
2/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.1%
10/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Infections and infestations
Gastroenteritis viral
|
0.53%
8/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.50%
3/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
9/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
42/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
3.2%
19/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.5%
9/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.2%
20/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.4%
36/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.3%
14/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.4%
8/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.7%
24/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
20/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.1%
19/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.46%
7/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.84%
5/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.17%
1/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
9/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
18/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.8%
11/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.51%
3/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.4%
13/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.86%
13/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.50%
3/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.34%
2/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.3%
12/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Nervous system disorders
Headache
|
2.8%
42/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
3.5%
21/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.6%
15/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.6%
23/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Nervous system disorders
Dizziness
|
0.33%
5/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.51%
3/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.33%
3/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
19/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.5%
9/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
9/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
16/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.6%
14/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
19/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.50%
3/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.85%
5/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.67%
6/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.93%
14/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.0%
6/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.4%
14/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
11/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.93%
14/1508 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
1.2%
7/598 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.85%
5/587 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.56%
5/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Skin and subcutaneous tissue disorders
Pain at injection site -Any (reactogenicity event)
|
93.3%
1403/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
91.1%
544/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
92.5%
541/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
58.5%
525/897 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Skin and subcutaneous tissue disorders
Redness -Any (reactogenicity event)
|
24.3%
365/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
22.8%
136/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
24.8%
145/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.4%
21/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
Skin and subcutaneous tissue disorders
Swelling -Any (reactogenicity event)
|
27.7%
416/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
27.0%
161/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
27.0%
158/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
2.9%
26/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Fever >=38.0 degrees C -Any (reactogenicity event)
|
10.2%
154/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
8.7%
52/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
9.7%
57/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
5.2%
46/892 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Vomiting -Any (reactogenicity event)
|
7.3%
110/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
5.2%
31/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
7.5%
44/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
4.6%
41/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Diarrhea-Any (reactogenicity event)
|
19.5%
294/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
19.1%
114/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
20.0%
117/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
20.9%
187/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Headache -Any (reactogenicity event)
|
68.6%
1032/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
63.5%
379/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
67.0%
392/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
53.4%
477/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Fatigue -Any (reactogenicity event)
|
67.2%
1011/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
63.7%
380/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
63.1%
369/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
50.8%
454/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Chills-Any (reactogenicity event)
|
37.6%
566/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
30.7%
183/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
38.5%
225/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
25.4%
227/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Muscle pain -Any (reactogenicity event)
|
39.8%
598/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
34.3%
205/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
35.9%
210/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
28.4%
254/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
|
General disorders
Joint pain -Any (reactogenicity event)
|
35.4%
532/1504 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
28.5%
170/597 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
32.6%
191/585 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
23.4%
209/893 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER