Trial Outcomes & Findings for A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years. (NCT NCT01352845)
NCT ID: NCT01352845
Last Updated: 2016-02-23
Results Overview
Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3301 participants
Primary outcome timeframe
One month after third bivalent rLP2086 vaccination
Results posted on
2016-02-23
Participant Flow
A total of 3304 participants were randomized in this study, out of which 3293 participants received vaccination.
Participant milestones
| Measure |
Group 1 rLP2086
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
2471
|
822
|
|
Overall Study
COMPLETED
|
1800
|
619
|
|
Overall Study
NOT COMPLETED
|
671
|
203
|
Reasons for withdrawal
| Measure |
Group 1 rLP2086
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
313
|
92
|
|
Overall Study
No Longer Willing to Participate
|
205
|
58
|
|
Overall Study
Withdrawal by Subject
|
48
|
16
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
24
|
11
|
|
Overall Study
Pregnancy
|
27
|
7
|
|
Overall Study
Adverse Event
|
22
|
6
|
|
Overall Study
Other
|
17
|
7
|
|
Overall Study
Protocol Violation
|
12
|
6
|
|
Overall Study
Death
|
3
|
0
|
Baseline Characteristics
A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
Baseline characteristics by cohort
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
Total
n=3293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.47 Years
STANDARD_DEVIATION 2.14 • n=5 Participants
|
21.52 Years
STANDARD_DEVIATION 2.20 • n=7 Participants
|
21.48 Years
STANDARD_DEVIATION 2.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1452 Participants
n=5 Participants
|
482 Participants
n=7 Participants
|
1934 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1019 Participants
n=5 Participants
|
340 Participants
n=7 Participants
|
1359 Participants
n=5 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.
Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=1723 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
Composite hSBA response (N=1664)
|
84.9 Percentage of participants
Interval 83.1 to 86.6
|
—
|
|
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
PMB80 [A22] (N=1695)
|
80.5 Percentage of participants
Interval 78.6 to 82.4
|
—
|
|
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
PMB2001 [A56] (N=1642)
|
90.0 Percentage of participants
Interval 88.4 to 91.4
|
—
|
|
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
PMB2948 [B24] (N=1675)
|
79.3 Percentage of participants
Interval 77.3 to 81.2
|
—
|
|
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
PMB2707 [B44] (N=1696)
|
79.6 Percentage of participants
Interval 77.6 to 81.5
|
—
|
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 saline) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086
n=2425 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=798 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Any
|
15.5 Percentage of participants
Interval 14.1 to 17.1
|
0.6 Percentage of participants
Interval 0.2 to 1.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Mild
|
8.5 Percentage of participants
Interval 7.4 to 9.7
|
0.3 Percentage of participants
Interval 0.0 to 0.9
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Any
|
84.2 Percentage of participants
Interval 82.7 to 85.6
|
11.8 Percentage of participants
Interval 9.6 to 14.2
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Mild
|
42.3 Percentage of participants
Interval 40.3 to 44.3
|
10.7 Percentage of participants
Interval 8.6 to 13.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Moderate
|
37.1 Percentage of participants
Interval 35.1 to 39.0
|
1.1 Percentage of participants
Interval 0.5 to 2.1
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Pain at injection site: Severe
|
4.8 Percentage of participants
Interval 4.0 to 5.8
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Any
|
13.8 Percentage of participants
Interval 12.5 to 15.3
|
0.6 Percentage of participants
Interval 0.2 to 1.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Mild
|
5.8 Percentage of participants
Interval 4.9 to 6.8
|
0.5 Percentage of participants
Interval 0.1 to 1.3
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Moderate
|
7.1 Percentage of participants
Interval 6.1 to 8.2
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Redness: Severe
|
0.9 Percentage of participants
Interval 0.6 to 1.4
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Moderate
|
6.8 Percentage of participants
Interval 5.8 to 7.9
|
0.3 Percentage of participants
Interval 0.0 to 0.9
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Swelling: Severe
|
0.2 Percentage of participants
Interval 0.1 to 0.5
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
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) and for whom safety information was available from second vaccination until prior to third vaccination.
Outcome measures
| Measure |
Group 1 rLP2086
n=2076 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=706 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Any
|
79.3 Percentage of participants
Interval 77.5 to 81.1
|
7.8 Percentage of participants
Interval 5.9 to 10.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Mild
|
42.2 Percentage of participants
Interval 40.1 to 44.4
|
6.8 Percentage of participants
Interval 5.1 to 8.9
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Moderate
|
32.7 Percentage of participants
Interval 30.7 to 34.8
|
1.0 Percentage of participants
Interval 0.4 to 2.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Pain at injection site: Severe
|
4.4 Percentage of participants
Interval 3.6 to 5.4
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Any
|
11.8 Percentage of participants
Interval 10.4 to 13.3
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Mild
|
4.6 Percentage of participants
Interval 3.7 to 5.6
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Moderate
|
6.3 Percentage of participants
Interval 5.3 to 7.4
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Redness: Severe
|
0.9 Percentage of participants
Interval 0.6 to 1.4
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Any
|
14.0 Percentage of participants
Interval 12.6 to 15.6
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Mild
|
7.7 Percentage of participants
Interval 6.6 to 8.9
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Moderate
|
6.0 Percentage of participants
Interval 5.0 to 7.1
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Swelling: Severe
|
0.3 Percentage of participants
Interval 0.1 to 0.7
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
PRIMARY outcome
Timeframe: Within 7 days after third vaccinationPopulation: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086
n=1823 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=624 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Any
|
80.4 Percentage of participants
Interval 78.5 to 82.2
|
6.7 Percentage of participants
Interval 4.9 to 9.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Mild
|
36.1 Percentage of participants
Interval 33.9 to 38.4
|
6.4 Percentage of participants
Interval 4.6 to 8.6
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Moderate
|
38.9 Percentage of participants
Interval 36.6 to 41.2
|
0.3 Percentage of participants
Interval 0.0 to 1.2
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Pain at injection site: Severe
|
5.3 Percentage of participants
Interval 4.3 to 6.5
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Any
|
17.1 Percentage of participants
Interval 15.4 to 18.9
|
0.2 Percentage of participants
Interval 0.0 to 0.9
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Mild
|
6.2 Percentage of participants
Interval 5.1 to 7.4
|
0.2 Percentage of participants
Interval 0.0 to 0.9
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Moderate
|
8.6 Percentage of participants
Interval 7.3 to 9.9
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Redness: Severe
|
2.3 Percentage of participants
Interval 1.7 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Any
|
16.6 Percentage of participants
Interval 14.9 to 18.4
|
0.3 Percentage of participants
Interval 0.0 to 1.2
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Mild
|
8.8 Percentage of participants
Interval 7.6 to 10.2
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Moderate
|
7.2 Percentage of participants
Interval 6.1 to 8.5
|
0.3 Percentage of participants
Interval 0.0 to 1.2
|
|
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Swelling: Severe
|
0.5 Percentage of participants
Interval 0.2 to 0.9
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
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 saline) and for whom safety information was available from first vaccination until prior to second vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.
Outcome measures
| Measure |
Group 1 rLP2086
n=2425 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=798 Participants
Saline 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=2415, 796)
|
2.4 Percentage of participants
Interval 1.8 to 3.0
|
0.6 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
Fever 38 to <38.5 degreesC(N=2415, 796)
|
1.6 Percentage of participants
Interval 1.1 to 2.2
|
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
Fever 38.5 to<39 degrees C(N=2415, 796)
|
0.7 Percentage of participants
Interval 0.4 to 1.2
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fever 39 to 40 degrees C (N=2415, 796)
|
0.0 Percentage of participants
Interval 0.0 to 0.2
|
0.3 Percentage of participants
Interval 0.0 to 0.9
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fever >40 degrees C(N=2415, 796)
|
0.0 Percentage of participants
Interval 0.0 to 0.2
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Any(N=2425, 798)
|
2.6 Percentage of participants
Interval 2.0 to 3.3
|
2.1 Percentage of participants
Interval 1.2 to 3.4
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Mild(N=2425, 798)
|
2.2 Percentage of participants
Interval 1.6 to 2.8
|
2.1 Percentage of participants
Interval 1.2 to 3.4
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Moderate(N=2425, 798)
|
0.4 Percentage of participants
Interval 0.2 to 0.8
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Vomiting:Severe(N=2425, 798)
|
0.0 Percentage of participants
Interval 0.0 to 0.2
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Any(N=2425, 798)
|
12.7 Percentage of participants
Interval 11.4 to 14.1
|
11.8 Percentage of participants
Interval 9.6 to 14.2
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Mild(N=2425, 798)
|
10.2 Percentage of participants
Interval 9.0 to 11.5
|
9.8 Percentage of participants
Interval 7.8 to 12.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Moderate(N=2425, 798)
|
2.4 Percentage of participants
Interval 1.8 to 3.0
|
1.9 Percentage of participants
Interval 1.1 to 3.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Diarrhea:Severe(N=2425, 798)
|
0.2 Percentage of participants
Interval 0.1 to 0.5
|
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 First Vaccination
Headache:Any(N=2425, 798)
|
43.9 Percentage of participants
Interval 41.9 to 45.9
|
36.2 Percentage of participants
Interval 32.9 to 39.7
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Headache:Mild(N=2425, 798)
|
24.3 Percentage of participants
Interval 22.6 to 26.1
|
22.1 Percentage of participants
Interval 19.2 to 25.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Headache:Moderate(N=2425, 798)
|
17.9 Percentage of participants
Interval 16.4 to 19.5
|
13.5 Percentage of participants
Interval 11.2 to 16.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Headache:Severe(N=2425, 798)
|
1.6 Percentage of participants
Interval 1.2 to 2.2
|
0.6 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=2425, 798)
|
50.9 Percentage of participants
Interval 48.9 to 52.9
|
39.8 Percentage of participants
Interval 36.4 to 43.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fatigue:Mild(N=2425, 798)
|
25.4 Percentage of participants
Interval 23.7 to 27.2
|
23.2 Percentage of participants
Interval 20.3 to 26.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fatigue:Moderate(N=2425, 798)
|
22.1 Percentage of participants
Interval 20.5 to 23.8
|
15.8 Percentage of participants
Interval 13.3 to 18.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Fatigue:Severe(N=2425, 798)
|
3.4 Percentage of participants
Interval 2.7 to 4.2
|
0.9 Percentage of participants
Interval 0.4 to 1.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Chills:Any(N=2425, 798)
|
18.1 Percentage of participants
Interval 16.5 to 19.7
|
9.8 Percentage of participants
Interval 7.8 to 12.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Chills:Mild(N=2425, 798)
|
12.0 Percentage of participants
Interval 10.8 to 13.4
|
8.1 Percentage of participants
Interval 6.3 to 10.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Chills:Moderate(N=2425, 798)
|
4.9 Percentage of participants
Interval 4.1 to 5.8
|
1.6 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: Severe(N=2425, 798)
|
1.1 Percentage of participants
Interval 0.7 to 1.6
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Any(N=2425,798)
|
25.9 Percentage of participants
Interval 24.1 to 27.6
|
14.5 Percentage of participants
Interval 12.2 to 17.2
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Mild(N=2425,798)
|
13.0 Percentage of participants
Interval 11.7 to 14.4
|
9.6 Percentage of participants
Interval 7.7 to 11.9
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Moderate(N=2425,798)
|
11.3 Percentage of participants
Interval 10.0 to 12.6
|
4.4 Percentage of participants
Interval 3.1 to 6.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Muscle pain:Severe(N=2425,798)
|
1.6 Percentage of participants
Interval 1.1 to 2.2
|
0.5 Percentage of participants
Interval 0.1 to 1.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain:Any(N=2425,798)
|
19.6 Percentage of participants
Interval 18.1 to 21.3
|
10.9 Percentage of participants
Interval 8.8 to 13.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain:Mild(N=2425,798)
|
10.3 Percentage of participants
Interval 9.1 to 11.6
|
6.9 Percentage of participants
Interval 5.2 to 8.9
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain:Moderate(N=2425,798)
|
7.9 Percentage of participants
Interval 6.8 to 9.0
|
3.5 Percentage of participants
Interval 2.3 to 5.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Joint pain: Severe(N=2425,798)
|
1.4 Percentage of participants
Interval 1.0 to 2.0
|
0.5 Percentage of participants
Interval 0.1 to 1.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Antipyretic medication(N=2425,798)
|
13.4 Percentage of participants
Interval 12.1 to 14.8
|
8.9 Percentage of participants
Interval 7.0 to 11.1
|
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) and for whom safety information was available from second vaccination until prior to third vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.
Outcome measures
| Measure |
Group 1 rLP2086
n=2076 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=706 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever 39 to 40 degrees C (N=2067, 705)
|
0.1 Percentage of participants
Interval 0.0 to 0.3
|
0.1 Percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever >=38 degrees C(N=2067, 705)
|
1.2 Percentage of participants
Interval 0.7 to 1.7
|
1.0 Percentage of participants
Interval 0.4 to 2.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever 38 to <38.5 degreesC(N=2067, 705)
|
0.7 Percentage of participants
Interval 0.4 to 1.1
|
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
Fever 38.5 to<39 degrees C(N=2067, 705)
|
0.4 Percentage of participants
Interval 0.2 to 0.8
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fever >40 degrees C(N=2067, 705)
|
0.0 Percentage of participants
Interval 0.0 to 0.2
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Any(N=2076, 706)
|
2.1 Percentage of participants
Interval 1.5 to 2.8
|
1.6 Percentage of participants
Interval 0.8 to 2.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Mild(N=2076, 706)
|
1.6 Percentage of participants
Interval 1.1 to 2.3
|
1.3 Percentage of participants
Interval 0.6 to 2.4
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Moderate(N=2076, 706)
|
0.5 Percentage of participants
Interval 0.2 to 0.9
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Vomiting:Severe(N=2076, 706)
|
0.0 Percentage of participants
Interval 0.0 to 0.2
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Any(N=2076, 706)
|
8.6 Percentage of participants
Interval 7.4 to 9.9
|
8.1 Percentage of participants
Interval 6.2 to 10.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Mild(N=2076, 706)
|
6.4 Percentage of participants
Interval 5.3 to 7.5
|
4.7 Percentage of participants
Interval 3.2 to 6.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Moderate(N=2076, 706)
|
1.7 Percentage of participants
Interval 1.2 to 2.4
|
2.8 Percentage of participants
Interval 1.7 to 4.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Diarrhea:Severe(N=2076, 706)
|
0.5 Percentage of participants
Interval 0.3 to 0.9
|
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
Headache:Any(N=2076, 706)
|
33.1 Percentage of participants
Interval 31.1 to 35.2
|
24.9 Percentage of participants
Interval 21.8 to 28.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Headache:Mild(N=2076, 706)
|
18.4 Percentage of participants
Interval 16.8 to 20.1
|
13.6 Percentage of participants
Interval 11.2 to 16.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Headache:Moderate(N=2076, 706)
|
13.3 Percentage of participants
Interval 11.9 to 14.8
|
10.1 Percentage of participants
Interval 7.9 to 12.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Headache:Severe(N=2076, 706)
|
1.4 Percentage of participants
Interval 1.0 to 2.1
|
1.3 Percentage of participants
Interval 0.6 to 2.4
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Any(N=2076, 706)
|
39.2 Percentage of participants
Interval 37.1 to 41.3
|
27.3 Percentage of participants
Interval 24.1 to 30.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Mild(N=2076, 706)
|
20.6 Percentage of participants
Interval 18.8 to 22.4
|
13.9 Percentage of participants
Interval 11.4 to 16.7
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Moderate(N=2076, 706)
|
16.4 Percentage of participants
Interval 14.8 to 18.0
|
11.5 Percentage of participants
Interval 9.2 to 14.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Fatigue:Severe(N=2076, 706)
|
2.2 Percentage of participants
Interval 1.6 to 2.9
|
2.0 Percentage of participants
Interval 1.1 to 3.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills:Any(N=2076, 706)
|
12.4 Percentage of participants
Interval 11.0 to 13.9
|
8.5 Percentage of participants
Interval 6.5 to 10.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills:Mild(N=2076, 706)
|
8.1 Percentage of participants
Interval 7.0 to 9.4
|
6.9 Percentage of participants
Interval 5.2 to 9.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills:Moderate(N=2076, 706)
|
3.5 Percentage of participants
Interval 2.8 to 4.4
|
1.6 Percentage of participants
Interval 0.8 to 2.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Chills: Severe(N=2076, 706)
|
0.8 Percentage of participants
Interval 0.4 to 1.2
|
0.0 Percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Any(N=2076, 706)
|
15.6 Percentage of participants
Interval 14.0 to 17.2
|
8.5 Percentage of participants
Interval 6.5 to 10.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Mild(N=2076, 706)
|
7.6 Percentage of participants
Interval 6.5 to 8.8
|
5.8 Percentage of participants
Interval 4.2 to 7.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Moderate(N=2076, 706)
|
7.1 Percentage of participants
Interval 6.1 to 8.3
|
2.3 Percentage of participants
Interval 1.3 to 3.7
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Muscle pain:Severe(N=2076, 706)
|
0.8 Percentage of participants
Interval 0.5 to 1.3
|
0.4 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
Joint pain:Any(N=2076, 706)
|
15.1 Percentage of participants
Interval 13.6 to 16.7
|
6.5 Percentage of participants
Interval 4.8 to 8.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Joint pain:Mild(N=2076, 706)
|
8.1 Percentage of participants
Interval 7.0 to 9.3
|
3.7 Percentage of participants
Interval 2.4 to 5.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Joint pain:Moderate(N=2076, 706)
|
6.2 Percentage of participants
Interval 5.2 to 7.3
|
2.5 Percentage of participants
Interval 1.5 to 4.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Joint pain: Severe(N=2076, 706)
|
0.9 Percentage of participants
Interval 0.5 to 1.4
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Antipyretic medication(N=2076, 706)
|
12.3 Percentage of participants
Interval 10.9 to 13.8
|
7.6 Percentage of participants
Interval 5.8 to 9.9
|
PRIMARY outcome
Timeframe: Within 7 days after third vaccinationPopulation: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, 'N' signifies participants with known values reporting specific characteristic.
Outcome measures
| Measure |
Group 1 rLP2086
n=1823 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=624 Participants
Saline 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=1814, 621)
|
2.0 Percentage of participants
Interval 1.4 to 2.7
|
0.6 Percentage of participants
Interval 0.2 to 1.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever 38 to <38.5 degreesC(N=1814, 621)
|
1.4 Percentage of participants
Interval 0.9 to 2.0
|
0.5 Percentage of participants
Interval 0.1 to 1.4
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever 38.5 to<39 degrees C(N=1814, 621)
|
0.4 Percentage of participants
Interval 0.2 to 0.9
|
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
Fever 39 to 40 degrees C (N=1814, 621)
|
0.1 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fever >40 degrees C(N=1814, 621)
|
0.1 Percentage of participants
Interval 0.0 to 0.3
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Any(N=1823, 624)
|
2.0 Percentage of participants
Interval 1.4 to 2.7
|
1.4 Percentage of participants
Interval 0.7 to 2.7
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Mild(N=1823, 624)
|
1.8 Percentage of participants
Interval 1.2 to 2.5
|
1.1 Percentage of participants
Interval 0.5 to 2.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Moderate(N=1823, 624)
|
0.2 Percentage of participants
Interval 0.1 to 0.6
|
0.3 Percentage of participants
Interval 0.0 to 1.2
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Vomiting:Severe(N=1823, 624)
|
0.0 Percentage of participants
Interval 0.0 to 0.2
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Any(N=1823, 624)
|
7.5 Percentage of participants
Interval 6.3 to 8.8
|
6.9 Percentage of participants
Interval 5.0 to 9.2
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Mild(N=1823, 624)
|
6.1 Percentage of participants
Interval 5.0 to 7.3
|
5.3 Percentage of participants
Interval 3.7 to 7.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Moderate(N=1823, 624)
|
1.2 Percentage of participants
Interval 0.8 to 1.8
|
1.3 Percentage of participants
Interval 0.6 to 2.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Diarrhea:Severe(N=1823, 624)
|
0.2 Percentage of participants
Interval 0.0 to 0.5
|
0.3 Percentage of participants
Interval 0.0 to 1.2
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Any(N=1823, 624)
|
32.5 Percentage of participants
Interval 30.4 to 34.7
|
21.6 Percentage of participants
Interval 18.5 to 25.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Mild(N=1823, 624)
|
17.6 Percentage of participants
Interval 15.9 to 19.4
|
12.5 Percentage of participants
Interval 10.0 to 15.4
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Moderate(N=1823, 624)
|
13.3 Percentage of participants
Interval 11.8 to 15.0
|
8.3 Percentage of participants
Interval 6.3 to 10.8
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Headache:Severe(N=1823, 624)
|
1.6 Percentage of participants
Interval 1.1 to 2.3
|
0.8 Percentage of participants
Interval 0.3 to 1.9
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Any(N=1823, 624)
|
39.3 Percentage of participants
Interval 37.1 to 41.6
|
24.5 Percentage of participants
Interval 21.2 to 28.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Mild(N=1823, 624)
|
18.9 Percentage of participants
Interval 17.2 to 20.8
|
13.1 Percentage of participants
Interval 10.6 to 16.0
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Moderate(N=1823, 624)
|
18.8 Percentage of participants
Interval 17.0 to 20.6
|
9.6 Percentage of participants
Interval 7.4 to 12.2
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Fatigue:Severe(N=1823, 624)
|
1.6 Percentage of participants
Interval 1.1 to 2.3
|
1.8 Percentage of participants
Interval 0.9 to 3.1
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills:Any(N=1823, 624)
|
12.6 Percentage of participants
Interval 11.1 to 14.2
|
6.4 Percentage of participants
Interval 4.6 to 8.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills:Mild(N=1823, 624)
|
7.7 Percentage of participants
Interval 6.5 to 9.0
|
4.3 Percentage of participants
Interval 2.9 to 6.2
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills:Moderate(N=1823, 624)
|
4.2 Percentage of participants
Interval 3.3 to 5.2
|
2.1 Percentage of participants
Interval 1.1 to 3.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Chills: Severe(N=1823, 624)
|
0.8 Percentage of participants
Interval 0.4 to 1.3
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Any(N=1823, 624)
|
16.9 Percentage of participants
Interval 15.2 to 18.7
|
7.5 Percentage of participants
Interval 5.6 to 9.9
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Mild(N=1823, 624)
|
8.9 Percentage of participants
Interval 7.7 to 10.3
|
4.5 Percentage of participants
Interval 3.0 to 6.4
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Moderate(N=1823, 624)
|
6.8 Percentage of participants
Interval 5.7 to 8.1
|
2.9 Percentage of participants
Interval 1.7 to 4.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Muscle pain:Severe(N=1823, 624)
|
1.2 Percentage of participants
Interval 0.7 to 1.8
|
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=1823, 624)
|
12.6 Percentage of participants
Interval 11.1 to 14.2
|
5.3 Percentage of participants
Interval 3.7 to 7.3
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Joint pain:Mild(N=1823, 624)
|
6.6 Percentage of participants
Interval 5.5 to 7.9
|
2.9 Percentage of participants
Interval 1.7 to 4.5
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Joint pain:Moderate(N=1823, 624)
|
5.4 Percentage of participants
Interval 4.4 to 6.5
|
2.4 Percentage of participants
Interval 1.4 to 3.9
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Joint pain: Severe(N=1823, 624)
|
0.6 Percentage of participants
Interval 0.3 to 1.1
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Antipyretic medication(N=1823, 624)
|
12.8 Percentage of participants
Interval 11.3 to 14.5
|
6.6 Percentage of participants
Interval 4.8 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 saline) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination
|
8.62 Percentage of participants
Interval 7.5 to 9.8
|
7.30 Percentage of participants
Interval 5.6 to 9.3
|
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
n=2169 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=733 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
|
10.10 Percentage of participants
Interval 8.9 to 11.4
|
10.10 Percentage of participants
Interval 8.0 to 12.5
|
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 saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086
n=1889 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=649 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
|
9.26 Percentage of participants
Interval 8.0 to 10.7
|
7.24 Percentage of participants
Interval 5.4 to 9.5
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
|
21.17 Percentage of participants
Interval 19.6 to 22.8
|
18.86 Percentage of participants
Interval 16.2 to 21.7
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
|
31.20 Percentage of participants
Interval 29.4 to 33.1
|
31.14 Percentage of participants
Interval 28.0 to 34.4
|
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 saline) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
|
0.24 Percentage of participants
Interval 0.1 to 0.5
|
0.12 Percentage of participants
Interval 0.0 to 0.7
|
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
n=2169 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=733 Participants
Saline 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
|
0.00 Percentage of participants
Interval 0.0 to 0.5
|
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 saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086
n=1889 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=649 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
|
0.11 Percentage of participants
Interval 0.0 to 0.4
|
0.15 Percentage of participants
Interval 0.0 to 0.9
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
|
0.53 Percentage of participants
Interval 0.3 to 0.9
|
0.24 Percentage of participants
Interval 0.0 to 0.9
|
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 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
n=2067 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=704 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase
|
0.63 Percentage of participants
Interval 0.3 to 1.1
|
0.71 Percentage of participants
Interval 0.2 to 1.6
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
|
0.85 Percentage of participants
Interval 0.5 to 1.3
|
0.73 Percentage of participants
Interval 0.3 to 1.6
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
|
1.34 Percentage of participants
Interval 0.9 to 1.9
|
1.34 Percentage of participants
Interval 0.7 to 2.4
|
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 saline) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
|
3.89 Percentage of participants
Interval 3.2 to 4.7
|
3.77 Percentage of participants
Interval 2.6 to 5.3
|
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
n=2169 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=733 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
|
4.66 Percentage of participants
Interval 3.8 to 5.6
|
4.91 Percentage of participants
Interval 3.5 to 6.7
|
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 saline) and for whom safety information was available from third vaccination until until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086
n=1889 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=649 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
|
5.03 Percentage of participants
Interval 4.1 to 6.1
|
3.85 Percentage of participants
Interval 2.5 to 5.6
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
|
10.93 Percentage of participants
Interval 9.7 to 12.2
|
10.22 Percentage of participants
Interval 8.2 to 12.5
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
|
19.22 Percentage of participants
Interval 17.7 to 20.8
|
17.76 Percentage of participants
Interval 15.2 to 20.5
|
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 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
n=2067 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=704 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
|
6.97 Percentage of participants
Interval 5.9 to 8.2
|
6.68 Percentage of participants
Interval 4.9 to 8.8
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period
|
21.89 Percentage of participants
Interval 20.3 to 23.6
|
21.17 Percentage of participants
Interval 18.4 to 24.1
|
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 saline) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline 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
|
0.00 Percentage of participants
Interval 0.0 to 0.4
|
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
n=2169 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=733 Participants
Saline 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
|
0.23 Percentage of participants
Interval 0.1 to 0.5
|
0.00 Percentage of participants
Interval 0.0 to 0.5
|
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 saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086
n=1889 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=649 Participants
Saline 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
|
0.00 Percentage of participants
Interval 0.0 to 0.2
|
0.15 Percentage of participants
Interval 0.0 to 0.9
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline 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
|
0.20 Percentage of participants
Interval 0.1 to 0.5
|
0.12 Percentage of participants
Interval 0.0 to 0.7
|
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 saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
|
0.32 Percentage of participants
Interval 0.1 to 0.6
|
0.24 Percentage of participants
Interval 0.0 to 0.9
|
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 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
n=2067 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=704 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
|
0.10 Percentage of participants
Interval 0.0 to 0.3
|
0.00 Percentage of participants
Interval 0.0 to 0.5
|
PRIMARY outcome
Timeframe: From the first vaccination up to 6 month after the third vaccination the third vaccinationPopulation: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
|
0.40 Percentage of participants
Interval 0.2 to 0.7
|
0.24 Percentage of participants
Interval 0.0 to 0.9
|
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 saline) and for whom safety information was available from first vaccination until prior to second vaccination.
Outcome measures
| Measure |
Group 1 rLP2086
n=2471 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination
|
0.4 Percentage of participants
Interval 0.2 to 0.7
|
0.6 Percentage of participants
Interval 0.2 to 1.4
|
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
n=2169 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=733 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination
|
0.0 Percentage of participants
Interval 0.0 to 0.3
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
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 saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
Outcome measures
| Measure |
Group 1 rLP2086
n=1889 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=649 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination
|
0.1 Percentage of participants
Interval 0.0 to 0.3
|
0.0 Percentage of participants
Interval 0.0 to 0.6
|
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 saline) and had safety data available. Here, number of participants analyzed signifies subjects that were evaluable for this outcome measure.
Outcome measures
| Measure |
Group 1 rLP2086
n=167 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=63 Participants
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase
|
5.6 Days
Standard Deviation 10.75
|
5.6 Days
Standard Deviation 13.26
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=300 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB3010[A06]:Before Vaccination 1 (N=275)
|
16.0 Percentage of participants
Interval 11.9 to 20.9
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB3175[A29]:Before Vaccination 1 (N=280)
|
31.1 Percentage of participants
Interval 25.7 to 36.9
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB3175[A29]:1 Month after Vaccination 3 (N=283)
|
99.3 Percentage of participants
Interval 97.5 to 99.9
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB3010[A06]:1 Month after Vaccination 3 (N=275)
|
92.0 Percentage of participants
Interval 88.1 to 94.9
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB3040[A07]:Before Vaccination 1 (N=274)
|
55.8 Percentage of participants
Interval 49.7 to 61.8
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB3040[A07]:1 Month after Vaccination 3 (N=277)
|
95.7 Percentage of participants
Interval 92.6 to 97.7
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB824[A12]: Before Vaccination 1 (N=278)
|
5.0 Percentage of participants
Interval 2.8 to 8.3
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB824[A12]:1 Month after Vaccination 3 (N=275)
|
71.3 Percentage of participants
Interval 65.5 to 76.5
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB1672[A15]:Before Vaccination 1 (N=279)
|
37.3 Percentage of participants
Interval 31.6 to 43.2
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB1672[A15]:1 Month after Vaccination 3 (N=279)
|
91.8 Percentage of participants
Interval 87.9 to 94.7
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB1989[A19]:Before Vaccination 1 (N=278)
|
28.8 Percentage of participants
Interval 23.5 to 34.5
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB1989[A19]:1 Month after Vaccination 3 (N=284)
|
95.8 Percentage of participants
Interval 92.7 to 97.8
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB1256[B03]:Before Vaccination 1 (N=277)
|
11.2 Percentage of participants
Interval 7.7 to 15.5
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB1256[B03]:1 Month after Vaccination 3 (N=273)
|
86.4 Percentage of participants
Interval 81.8 to 90.3
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB866[B09]:Before Vaccination 1 (N=277)
|
23.5 Percentage of participants
Interval 18.6 to 28.9
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB866[B09]:1 Month after Vaccination 3 (N=274)
|
77.0 Percentage of participants
Interval 71.6 to 81.9
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB431[B15]:Before Vaccination 1 (N=274)
|
43.8 Percentage of participants
Interval 37.8 to 49.9
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB431[B15]:1 Month after Vaccination 3 (N=276)
|
96.7 Percentage of participants
Interval 93.9 to 98.5
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB648[B16]:Before Vaccination 1 (N=270)
|
21.9 Percentage of participants
Interval 17.1 to 27.3
|
—
|
|
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
PMB648[B16]:1 Month after Vaccination 3 (N=273)
|
78.0 Percentage of participants
Interval 72.6 to 82.8
|
—
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=300 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1672[A15] 1:16 (N=279)
|
33.3 Percentage of participants
Interval 27.8 to 39.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1672[A15] 1:16 (N=279)
|
91.4 Percentage of participants
Interval 87.5 to 94.4
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1672[A15] 1:32 (N=279)
|
20.4 Percentage of participants
Interval 15.9 to 25.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1672[A15] 1:32 (N=279)
|
82.4 Percentage of participants
Interval 77.5 to 86.7
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1672[A15] 1:64 (N=279)
|
7.2 Percentage of participants
Interval 4.4 to 10.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3175[A29] 1:8 (N=280)
|
31.1 Percentage of participants
Interval 25.7 to 36.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1672[A15] 1:64 (N=279)
|
54.5 Percentage of participants
Interval 48.4 to 60.4
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1672[A15] 1:128 (N=279)
|
1.8 Percentage of participants
Interval 0.6 to 4.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1672[A15] 1:128 (N=279)
|
19.0 Percentage of participants
Interval 14.6 to 24.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1989[A19] 1:4 (N=278)
|
39.2 Percentage of participants
Interval 33.4 to 45.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1989[A19] 1:4 (N=284)
|
96.1 Percentage of participants
Interval 93.2 to 98.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1989[A19] 1:8 (N=278)
|
37.1 Percentage of participants
Interval 31.4 to 43.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1989[A19] 1:8 (N=284)
|
96.1 Percentage of participants
Interval 93.2 to 98.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1989[A19] 1:16 (N=278)
|
28.8 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1989[A19] 1:16 (N=284)
|
95.8 Percentage of participants
Interval 92.7 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1989[A19] 1:32 (N=278)
|
18.3 Percentage of participants
Interval 14.0 to 23.4
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1989[A19] 1:32 (N=284)
|
92.3 Percentage of participants
Interval 88.5 to 95.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1989[A19] 1:64 (N=278)
|
9.0 Percentage of participants
Interval 5.9 to 13.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1989[A19] 1:64 (N=284)
|
77.5 Percentage of participants
Interval 72.2 to 82.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1989[A19] 1:128 (N=278)
|
9.0 Percentage of participants
Interval 5.9 to 13.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1989[A19] 1:128 (N=284)
|
49.6 Percentage of participants
Interval 43.7 to 55.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1256[B03] 1:4 (N=277)
|
13.0 Percentage of participants
Interval 9.3 to 17.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1256[B03] 1:4 (N=273)
|
86.8 Percentage of participants
Interval 82.2 to 90.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1256[B03] 1:8 (N=277)
|
11.2 Percentage of participants
Interval 7.7 to 15.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1256[B03] 1:8 (N=273)
|
86.4 Percentage of participants
Interval 81.8 to 90.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1256[B03] 1:16 (N=277)
|
10.1 Percentage of participants
Interval 6.8 to 14.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1256[B03] 1:16 (N=273)
|
85.3 Percentage of participants
Interval 80.6 to 89.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1256[B03] 1:32 (N=277)
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1256[B03] 1:32 (N=273)
|
78.4 Percentage of participants
Interval 73.0 to 83.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1256[B03] 1:64 (N=277)
|
4.7 Percentage of participants
Interval 2.5 to 7.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1256[B03] 1:64 (N=273)
|
56.4 Percentage of participants
Interval 50.3 to 62.4
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1256[B03] 1:128 (N=277)
|
1.1 Percentage of participants
Interval 0.2 to 3.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1256[B03] 1:128 (N=273)
|
30.8 Percentage of participants
Interval 25.3 to 36.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB866[B09] 1:4 (N=277)
|
24.5 Percentage of participants
Interval 19.6 to 30.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB866[B09] 1:4 (N=274)
|
78.5 Percentage of participants
Interval 73.1 to 83.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB866[B09] 1:8 (N=277)
|
23.5 Percentage of participants
Interval 18.6 to 28.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB866[B09] 1:8 (N=274)
|
77.0 Percentage of participants
Interval 71.6 to 81.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB866[B09] 1:16 (N=277)
|
18.8 Percentage of participants
Interval 14.3 to 23.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB866[B09] 1:16 (N=274)
|
73.4 Percentage of participants
Interval 67.7 to 78.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB866[B09] 1:32 (N=277)
|
11.9 Percentage of participants
Interval 8.3 to 16.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB866[B09] 1:32 (N=274)
|
52.6 Percentage of participants
Interval 46.5 to 58.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB866[B09] 1:64 (N=277)
|
4.7 Percentage of participants
Interval 2.5 to 7.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB866[B09] 1:64 (N=274)
|
27.7 Percentage of participants
Interval 22.5 to 33.4
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB866[B09] 1:128 (N=277)
|
1.1 Percentage of participants
Interval 0.2 to 3.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB866[B09] 1:128 (N=274)
|
12.8 Percentage of participants
Interval 9.1 to 17.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB431[B15] 1:4 (N=274)
|
44.9 Percentage of participants
Interval 38.9 to 51.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB431[B15] 1:4 (N=276)
|
97.1 Percentage of participants
Interval 94.4 to 98.7
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB431[B15] 1:8 (N=274)
|
43.8 Percentage of participants
Interval 37.8 to 49.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB431[B15] 1:8 (N=276)
|
96.7 Percentage of participants
Interval 93.9 to 98.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB431[B15] 1:16 (N=274)
|
41.2 Percentage of participants
Interval 35.4 to 47.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB431[B15] 1:16 (N=276)
|
96.7 Percentage of participants
Interval 93.9 to 98.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB431[B15] 1:32 (N=274)
|
23.7 Percentage of participants
Interval 18.8 to 29.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB431[B15] 1:32 (N=276)
|
84.4 Percentage of participants
Interval 79.6 to 88.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB431[B15] 1:64 (N=274)
|
8.0 Percentage of participants
Interval 5.1 to 11.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB431[B15] 1:64 (N=276)
|
56.5 Percentage of participants
Interval 50.4 to 62.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB431[B15] 1:128 (N=274)
|
1.5 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB431[B15] 1:128 (N=276)
|
22.5 Percentage of participants
Interval 17.7 to 27.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB648[B16] 1:4 (N=270)
|
24.4 Percentage of participants
Interval 19.4 to 30.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB648[B16] 1:4 (N=273)
|
79.1 Percentage of participants
Interval 73.8 to 83.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB648[B16] 1:8 (N=270)
|
21.9 Percentage of participants
Interval 17.1 to 27.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB648[B16] 1:8 (N=273)
|
78.0 Percentage of participants
Interval 72.6 to 82.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB648[B16] 1:16 (N=270)
|
18.9 Percentage of participants
Interval 14.4 to 24.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB648[B16] 1:16 (N=273)
|
76.6 Percentage of participants
Interval 71.1 to 81.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB648[B16] 1:32 (N=270)
|
11.9 Percentage of participants
Interval 8.2 to 16.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB648[B16] 1:32 (N=273)
|
61.2 Percentage of participants
Interval 55.1 to 67.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB648[B16] 1:64 (N=270)
|
7.4 Percentage of participants
Interval 4.6 to 11.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB648[B16] 1:64 (N=273)
|
34.4 Percentage of participants
Interval 28.8 to 40.4
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB648[B16] 1:128 (N=270)
|
1.9 Percentage of participants
Interval 0.6 to 4.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB648[B16] 1:128 (N=273)
|
16.8 Percentage of participants
Interval 12.6 to 21.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3010[A06] 1:64 (N=275)
|
70.5 Percentage of participants
Interval 64.8 to 75.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3175[A29] 1:8 (N=283)
|
99.3 Percentage of participants
Interval 97.5 to 99.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3175[A29] 1:16 (N=280)
|
27.9 Percentage of participants
Interval 22.7 to 33.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3175[A29] 1:16 (N=283)
|
98.9 Percentage of participants
Interval 96.9 to 99.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3175[A29] 1:32 (N=280)
|
16.1 Percentage of participants
Interval 12.0 to 20.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3175[A29] 1:4 (N=280)
|
32.9 Percentage of participants
Interval 27.4 to 38.7
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3175[A29] 1:4 (N=283)
|
99.3 Percentage of participants
Interval 97.5 to 99.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3175[A29] 1:32 (N=283)
|
96.8 Percentage of participants
Interval 94.0 to 98.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3175[A29] 1:64 (N=280)
|
5.7 Percentage of participants
Interval 3.3 to 9.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3175[A29] 1:64 (N=283)
|
80.9 Percentage of participants
Interval 75.8 to 85.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3175[A29] 1:128 (N=280)
|
2.1 Percentage of participants
Interval 0.8 to 4.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3175[A29] 1:128 (N=283)
|
53.0 Percentage of participants
Interval 47.0 to 58.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3010[A06] 1:4 (N=275)
|
18.9 Percentage of participants
Interval 14.5 to 24.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3010[A06] 1:4 (N=275)
|
92.4 Percentage of participants
Interval 88.6 to 95.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3010[A06] 1:8 (N=275)
|
17.5 Percentage of participants
Interval 13.2 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3010[A06] 1:8 (N=275)
|
92.4 Percentage of participants
Interval 88.6 to 95.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3010[A06] 1:16 (N=275)
|
16.0 Percentage of participants
Interval 11.9 to 20.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3010[A06] 1:16 (N=275)
|
92.0 Percentage of participants
Interval 88.1 to 94.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3010[A06] 1:32 (N=275)
|
10.5 Percentage of participants
Interval 7.2 to 14.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3010 [A06] 1:32 (N=275)
|
86.2 Percentage of participants
Interval 81.5 to 90.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3010[A06] 1:64 (N=275)
|
6.5 Percentage of participants
Interval 3.9 to 10.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3010[A06] 1:128 (N=275)
|
2.5 Percentage of participants
Interval 1.0 to 5.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3010[A06] 1:128 (N=275)
|
41.8 Percentage of participants
Interval 35.9 to 47.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3040[A07] 1:4 (N=274)
|
55.8 Percentage of participants
Interval 49.7 to 61.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3040[A07] 1:4 (N=277)
|
95.7 Percentage of participants
Interval 92.6 to 97.7
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3040[A07] 1:8 (N=274)
|
55.8 Percentage of participants
Interval 49.7 to 61.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3040[A07] 1:8 (N=277)
|
95.7 Percentage of participants
Interval 92.6 to 97.7
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3040[A07] 1:16 (N=274)
|
55.5 Percentage of participants
Interval 49.4 to 61.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3040[A07] 1:16 (N=277)
|
95.7 Percentage of participants
Interval 92.6 to 97.7
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3040[A07] 1:32 (N=274)
|
42.7 Percentage of participants
Interval 36.8 to 48.8
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3040[A07] 1:32 (N=277)
|
92.4 Percentage of participants
Interval 88.6 to 95.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3040[A07] 1:64 (N=274)
|
21.2 Percentage of participants
Interval 16.5 to 26.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3040[A07] 1:64 (N=277)
|
72.9 Percentage of participants
Interval 67.3 to 78.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB3040[A07] 1:128 (N=274)
|
4.0 Percentage of participants
Interval 2.0 to 7.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB3040[A07] 1:128 (N=277)
|
29.2 Percentage of participants
Interval 24.0 to 35.0
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB824[A12] 1:4 (N=278)
|
10.4 Percentage of participants
Interval 7.1 to 14.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB824[A12] 1:4 (N=275)
|
73.8 Percentage of participants
Interval 68.2 to 78.9
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB824[A12] 1:8 (N=278)
|
8.3 Percentage of participants
Interval 5.3 to 12.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB824[A12] 1:8 (N=275)
|
73.5 Percentage of participants
Interval 67.8 to 78.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB824[A12] 1:16 (N=278)
|
5.0 Percentage of participants
Interval 2.8 to 8.3
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB824[A12] 1:16 (N=275)
|
71.3 Percentage of participants
Interval 65.5 to 76.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB824[A12] 1:32 (N=278)
|
2.2 Percentage of participants
Interval 0.8 to 4.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB824[A12] 1:32 (N=275)
|
46.5 Percentage of participants
Interval 40.5 to 52.6
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB824[A12] 1:64 (N=278)
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB824[A12] 1:64 (N=275)
|
15.6 Percentage of participants
Interval 11.6 to 20.5
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB824[A12] 1:128 (N=278)
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB824[A12] 1:128 (N=275)
|
3.3 Percentage of participants
Interval 1.5 to 6.1
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1672[A15] 1:4 (N=279)
|
39.4 Percentage of participants
Interval 33.7 to 45.4
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1672[A15] 1:4 (N=279)
|
91.8 Percentage of participants
Interval 87.9 to 94.7
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Before Vaccination 1: PMB1672[A15] 1:8 (N=279)
|
37.3 Percentage of participants
Interval 31.6 to 43.2
|
—
|
|
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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB1672[A15] 1:8 (N=279)
|
91.8 Percentage of participants
Interval 87.9 to 94.7
|
—
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=300 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline 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: Group 1
PMB3175[A29]:Before Vaccination 1 (N=280)
|
7.1 Titers
Interval 6.4 to 8.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB3175[A29]:1 Month after Vaccination 3 (N=283)
|
96.3 Titers
Interval 86.9 to 106.9
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB3010[A06]:Before Vaccination 1 (N=275)
|
10.3 Titers
Interval 9.5 to 11.2
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB3010[A06]:1 Month after Vaccination 3 (N=275)
|
69.9 Titers
Interval 61.8 to 79.1
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB3040[A07]:Before Vaccination 1 (N=274)
|
13.9 Titers
Interval 12.0 to 16.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB3040[A07]:1 Month after Vaccination 3 (N=277)
|
60.4 Titers
Interval 54.6 to 66.8
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB824[A12]: Before Vaccination 1 (N=278)
|
8.4 Titers
Interval 8.2 to 8.6
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB824[A12]:1 Month after Vaccination 3 (N=275)
|
20.6 Titers
Interval 18.8 to 22.6
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB1672[A15]:Before Vaccination 1 (N=279)
|
8.0 Titers
Interval 7.1 to 9.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB1672[A15]:1 Month after Vaccination 3 (N=279)
|
43.1 Titers
Interval 38.4 to 48.4
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB1989[A19]:Before Vaccination 1 (N=278)
|
12.1 Titers
Interval 11.1 to 13.3
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB1989[A19]:1 Month after Vaccination 3 (N=284)
|
87.3 Titers
Interval 77.7 to 98.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB1256[B03]:Before Vaccination 1 (N=277)
|
5.1 Titers
Interval 4.7 to 5.6
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB1256[B03]:1 Month after Vaccination 3 (N=273)
|
49.8 Titers
Interval 42.2 to 58.7
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB866[B09]:Before Vaccination 1 (N=277)
|
6.1 Titers
Interval 5.5 to 6.7
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB866[B09]:1 Month after Vaccination 3 (N=274)
|
23.3 Titers
Interval 19.9 to 27.1
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB431[B15]:Before Vaccination 1 (N=274)
|
9.1 Titers
Interval 8.1 to 10.3
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB431[B15]:1 Month after Vaccination 3 (N=276)
|
49.4 Titers
Interval 44.6 to 54.8
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB648[B16]:Before Vaccination 1 (N=270)
|
6.2 Titers
Interval 5.5 to 6.9
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB648[B16]:1 Month after Vaccination 3 (N=273)
|
26.5 Titers
Interval 22.8 to 30.8
|
—
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=1723 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline 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: Group 1
Before First Vaccination (N=1612)
|
7.3 Percentage of participants
Interval 6.0 to 8.6
|
—
|
|
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: Group 1
1 Month after Vaccination 2 (N=1620)
|
64.5 Percentage of participants
Interval 62.1 to 66.8
|
—
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=1723 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline 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: Group 1
PMB80[A22] (N=1679)
|
66.9 Percentage of participants
Interval 64.6 to 69.2
|
—
|
|
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: Group 1
PMB2001[A56] (N=1637)
|
85.9 Percentage of participants
Interval 84.1 to 87.5
|
—
|
|
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: Group 1
PMB2948[B24] (N=1658)
|
67.9 Percentage of participants
Interval 65.6 to 70.2
|
—
|
|
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: Group 1
PMB2707[B44] (N=1686)
|
55.5 Percentage of participants
Interval 53.1 to 57.9
|
—
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=1723 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline 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: Group 1
Before Vac 1: PMB80[A22] 1:16 (N=1704)
|
33.6 Percentage of participants
Interval 31.3 to 35.9
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB80[A22] 1:16 (N=1697)
|
84.7 Percentage of participants
Interval 82.9 to 86.4
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB80[A22] 1:16 (N=1714)
|
93.5 Percentage of participants
Interval 92.2 to 94.6
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2001[A56] 1:8 (N=1657)
|
32.2 Percentage of participants
Interval 29.9 to 34.5
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2001[A56] 1:8) (N=1701)
|
97.4 Percentage of participants
Interval 96.5 to 98.1
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2001[A56] 1:8 (N=1708)
|
99.4 Percentage of participants
Interval 98.9 to 99.7
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2948[B24] 1:8 (N=1696)
|
33.1 Percentage of participants
Interval 30.9 to 35.4
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2948[B24] 1:8 (N=1685)
|
86.5 Percentage of participants
Interval 84.7 to 88.1
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3:PMB2948[B24] 1:8 (N=1702)
|
95.1 Percentage of participants
Interval 93.9 to 96.0
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2707[B44] 1:8 (N=1716)
|
11.0 Percentage of participants
Interval 9.6 to 12.6
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2707[B44] 1:8 (N=1693)
|
68.3 Percentage of participants
Interval 66.1 to 70.6
|
—
|
|
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2707[B44] 1:8 (N=1703)
|
87.4 Percentage of participants
Interval 85.8 to 89.0
|
—
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary endpoint 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1'.
Outcome measures
| Measure |
Group 1 rLP2086
n=1723 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline 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 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2948[B24] 1:32 (N=1702)
|
75.1 Percentage of participants
Interval 73.0 to 77.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB80[A22] 1:4 (N=1704)
|
42.1 Percentage of participants
Interval 39.7 to 44.5
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB80[A22] 1:4 (N=1697)
|
86.2 Percentage of participants
Interval 84.5 to 87.8
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB80[A22] 1:4 (N=1714)
|
94.3 Percentage of participants
Interval 93.1 to 95.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB80[A22] 1:8 (N=1704)
|
38.8 Percentage of participants
Interval 36.5 to 41.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB80[A22] 1:8 (N=1697)
|
85.7 Percentage of participants
Interval 83.9 to 87.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB80[A22] 1:8 (N=1714)
|
94.1 Percentage of participants
Interval 92.9 to 95.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB80[A22] 1:32 (N=1704)
|
19.7 Percentage of participants
Interval 17.8 to 21.6
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB80[A22] 1:32 (N=1697)
|
71.2 Percentage of participants
Interval 69.0 to 73.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB80[A22] 1:32 (N=1714)
|
85.5 Percentage of participants
Interval 83.8 to 87.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB80[A22] 1:64 (N=1704)
|
9.6 Percentage of participants
Interval 8.3 to 11.1
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB80[A22] 1:64 (N=1697)
|
49.9 Percentage of participants
Interval 47.4 to 52.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB80[A22] 1:64 (N=1714)
|
64.4 Percentage of participants
Interval 62.1 to 66.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB80[A22] 1:128 (N=1704)
|
3.4 Percentage of participants
Interval 2.6 to 4.4
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB80[A22] 1:128 (N=1697)
|
29.9 Percentage of participants
Interval 27.8 to 32.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB80[A22] 1:128 (N=1714)
|
41.7 Percentage of participants
Interval 39.4 to 44.1
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2001[A56] 1:4 (N=1657)
|
35.9 Percentage of participants
Interval 33.6 to 38.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2001[A56] 1:4 (N=1701)
|
97.8 Percentage of participants
Interval 97.0 to 98.5
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2001[A56] 1:4 (N=1708)
|
99.4 Percentage of participants
Interval 98.9 to 99.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2001[A56] 1:16 (N=1657)
|
30.4 Percentage of participants
Interval 28.2 to 32.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2001[A56] 1:16 (N=1701)
|
97.1 Percentage of participants
Interval 96.1 to 97.8
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2001[A56] 1:16 (N=1708)
|
99.2 Percentage of participants
Interval 98.7 to 99.6
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2001[A56] ] 1:32 (N=1657)
|
24.4 Percentage of participants
Interval 22.3 to 26.5
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2001[A56] 1:32 (N=1701)
|
92.8 Percentage of participants
Interval 91.4 to 94.0
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2001[A56] 1:32 (N=1708)
|
97.2 Percentage of participants
Interval 96.4 to 98.0
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2001[A56] 1:64 (N=1657)
|
16.4 Percentage of participants
Interval 14.6 to 18.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2 :PMB2001[A56] 1:64 (N=1701)
|
80.8 Percentage of participants
Interval 78.9 to 82.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3 :PMB2001[A56] 1:64 (N=1708)
|
90.5 Percentage of participants
Interval 89.0 to 91.9
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2001[A56] 1:128 (N=1657)
|
7.1 Percentage of participants
Interval 5.9 to 8.5
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2001[A56] 1:128 (N=1701)
|
56.6 Percentage of participants
Interval 54.2 to 58.9
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2001[A56] 1:128 (N=1708)
|
73.7 Percentage of participants
Interval 71.5 to 75.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2948[B24] 1:4 (N=1696)
|
35.0 Percentage of participants
Interval 32.7 to 37.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2948[B24] 1:4 (N=1685)
|
87.2 Percentage of participants
Interval 85.5 to 88.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2948[B24] 1:4 (N=1702)
|
95.8 Percentage of participants
Interval 94.8 to 96.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2948[B24] 1:16 (N=1696)
|
29.5 Percentage of participants
Interval 27.3 to 31.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2948[B24] 1:16 (N=1685)
|
83.7 Percentage of participants
Interval 81.9 to 85.5
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2948[B24] 1:16 (N=1702)
|
93.2 Percentage of participants
Interval 91.9 to 94.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2948[B24] 1:32 (N=1696)
|
18.1 Percentage of participants
Interval 16.3 to 20.0
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2948[B24] 1:32 (N=1685)
|
65.6 Percentage of participants
Interval 63.3 to 67.8
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2948[B24] 1:64 (N=1696)
|
8.4 Percentage of participants
Interval 7.1 to 9.8
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2948[B24] 1:64 (N=1685)
|
40.4 Percentage of participants
Interval 38.0 to 42.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2948[B24] 1:64 (N=1702)
|
48.8 Percentage of participants
Interval 46.4 to 51.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2948[B24] 1:128 (N=1696)
|
3.3 Percentage of participants
Interval 2.5 to 4.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2948[B24] 1:128 (N=1685)
|
22.8 Percentage of participants
Interval 20.9 to 24.9
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2948[B24] 1:128 (N=1702)
|
27.8 Percentage of participants
Interval 25.7 to 30.0
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2707[B44] 1:4 (N=1716)
|
14.5 Percentage of participants
Interval 12.8 to 16.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2707[B44] 1:4 (N=1693)
|
71.5 Percentage of participants
Interval 69.3 to 73.7
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2707[B44] 1:4 (N=1703)
|
89.7 Percentage of participants
Interval 88.1 to 91.1
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2707[B44] 1:16 (N=1716)
|
7.8 Percentage of participants
Interval 6.5 to 9.1
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2707[B44] 1:16 (N=1693)
|
61.0 Percentage of participants
Interval 58.6 to 63.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2707[B44] 1:16 (N=1703)
|
83.3 Percentage of participants
Interval 81.4 to 85.0
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2707[B44] 1:32 (N=1716)
|
4.3 Percentage of participants
Interval 3.4 to 5.4
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2707[B44] 1:32 (N=1693)
|
41.9 Percentage of participants
Interval 39.6 to 44.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2707[B44] 1:32 (N=1703)
|
67.1 Percentage of participants
Interval 64.8 to 69.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2707[B44] 1:64 (N=1716)
|
2.3 Percentage of participants
Interval 1.6 to 3.1
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2707[B44] 1:64 (N=1693)
|
30.3 Percentage of participants
Interval 28.1 to 32.6
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2707[B44] 1:64 (N=1703)
|
49.8 Percentage of participants
Interval 47.4 to 52.2
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Before Vac 1: PMB2707[B44] 1:128 (N=1716)
|
0.8 Percentage of participants
Interval 0.4 to 1.3
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 2: PMB2707[B44] 1:128 (N=1693)
|
21.0 Percentage of participants
Interval 19.1 to 23.0
|
—
|
|
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
1 month after Vac 3: PMB2707[B44] 1:128 (N=1703)
|
32.1 Percentage of participants
Interval 29.9 to 34.4
|
—
|
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. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=1723 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB80[A22]: Before Vac 1 (N=1704)
|
12.8 Titer
Interval 12.3 to 13.3
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB80[A22]: 1 Month after Vac 2 (N=1697)
|
49.0 Titer
Interval 46.2 to 52.1
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB80[A22]: 1 Month after Vac 3 (N=1714)
|
74.3 Titer
Interval 70.2 to 78.6
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2001[A56]: Before Vac 1 (N=1657)
|
8.8 Titer
Interval 8.3 to 9.3
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2001[A56]: 1 Month after Vac 2 (N=1701)
|
114.3 Titer
Interval 107.9 to 121.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2001[A56]: 1 Month after Vac 3 (N=1708)
|
176.7 Titer
Interval 167.8 to 186.1
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2948[B24]: Before Vac 1 (N=1696)
|
7.6 Titer
Interval 7.3 to 8.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2948[B24]: 1 Month after Vac 2 (N=1685)
|
35.8 Titer
Interval 33.7 to 38.2
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2948[B24]: 1 Month after Vac 3 (N=1702)
|
49.5 Titer
Interval 46.8 to 52.4
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2707[B44]: Before Vac 1 (N=1716)
|
4.8 Titer
Interval 4.7 to 4.9
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2707[B44]: 1 Month after Vac 2 (N=1693)
|
22.6 Titer
Interval 20.9 to 24.4
|
—
|
|
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
PMB2707[B44]: 1 Month after Vac 3 (N=1703)
|
47.6 Titer
Interval 44.2 to 51.3
|
—
|
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 vaccinationPopulation: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Outcome measures
| Measure |
Group 1 rLP2086
n=1723 Participants
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
Saline 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 Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB80[A22]: 1 Month after Vac 3 (N=1695)
|
89.0 Percentage of participants
Interval 87.4 to 90.4
|
—
|
|
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB2001[A56]: 1 Month after Vac 3 (N=1642)
|
95.3 Percentage of participants
Interval 94.2 to 96.3
|
—
|
|
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB2948[B24]: 1 Month after Vac 3 (N=1675)
|
87.1 Percentage of participants
Interval 85.4 to 88.7
|
—
|
|
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
PMB2707[B44]: 1 Month after Vac 3(N=1696)
|
81.8 Percentage of participants
Interval 79.9 to 83.6
|
—
|
Adverse Events
Group 1 rLP2086
Serious events: 33 serious events
Other events: 2193 other events
Deaths: 0 deaths
Group 2 Saline
Serious events: 11 serious events
Other events: 567 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 rLP2086
n=2471 participants at risk
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 participants at risk
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Colitis
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Gastritis
|
0.00%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.12%
3/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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 acute
|
0.00%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.08%
2/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Cystitis
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Anal abscess
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Mastoiditis
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Otosalpingitis
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Road traffic accident
|
0.08%
2/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Craniocerebral injury
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Tendon injury
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Intervertebral disc protrusion
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Migraine
|
0.00%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.24%
2/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Benign intracranial hypertension
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Dystonia
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.00%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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 spontaneous
|
0.16%
4/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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 missed
|
0.08%
2/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Ectopic pregnancy
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Hyperemesis gravidarum
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Completed suicide
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.00%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Dissociative disorder
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Eating disorder
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.12%
1/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Asthma
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
Pulmonary embolism
|
0.04%
1/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
0/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
n=2471 participants at risk
Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
|
Group 2 Saline
n=822 participants at risk
Saline on a 0-, 2-, 6- month schedule.
|
|---|---|---|
|
General disorders
Injection site pain
|
1.9%
46/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.73%
6/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.49%
12/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
10/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
4.0%
98/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
29/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
3.1%
77/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
4.0%
33/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
1.8%
45/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
10/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
1.5%
37/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
10/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
1.3%
33/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
12/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.77%
19/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
11/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.49%
12/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
10/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
1.3%
31/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.73%
6/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
0.89%
22/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
11/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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
|
2.2%
55/2471 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
10/822 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
89.6%
2184/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
18.2%
147/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
22.0%
537/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.99%
8/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
25.1%
612/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
0.99%
8/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
4.4%
108/2432 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
14/807 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
5.3%
130/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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%
37/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
20.4%
497/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
19.6%
158/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
59.1%
1440/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
48.4%
391/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
64.6%
1576/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
50.9%
411/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
28.6%
697/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
16.5%
133/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
37.6%
916/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
21.0%
170/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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)
|
29.7%
723/2438 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via electronic diary (reactogenicity events) are shown below as having been collected via systematic assessment. Reactogenicity events are grouped by all severities and doses combined.
|
16.8%
136/808 • AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination
All AEs collected on case report form are shown below as having been collected via non-systematic assessment. All events reported via 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