Meningococcal Vaccine
Conditions
Brief summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Interventions
BIOLOGICALrLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 1)
BIOLOGICALHavrix (HAV)
0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
BIOLOGICALSaline
0.5 mL dose of sterile normal saline for injection.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subject aged \>=10 and \<19 years at the time of enrollment. 2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 3. Negative urine pregnancy test for all female subjects.
Exclusion criteria
1. Previous vaccination with any meningococcal serogroup B vaccine. 2. Subjects who have received prior HAV vaccination. 3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination. 4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 5. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study. 6. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 7. Current chronic use of systemic antibiotics. 8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination. 9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase | From the first vaccination up to 1 month after the third vaccination | — |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase | From the first vaccination up to 1 month after the third vaccination | — |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase | From 1 month after third vaccination up to 6 months after the third vaccination | — |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period | From the first vaccination up to 6 month after the third vaccination | — |
| Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination | Within 30 days after first vaccination | — |
| Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | — |
| Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination | — |
| Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination | Within 30 Days after any vaccination | — |
| Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase | From the first vaccination up to 1 month after the third vaccination | — |
| Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination | Within 30 minutes after first vaccination | — |
| Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination | Within 30 minutes after second vaccination | — |
| Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination | Within 30 minutes after third vaccination | — |
| Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase | From the first vaccination up to 1 month after the third vaccination | — |
| Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase | From 1 month after third vaccination up to 6 months after the third vaccination | — |
| Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 | One month after third bivalent rLP2086 vaccination | Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. |
| hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine | One month after third bivalent rLP2086 vaccination | — |
| Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Within 7 Days after first vaccination | — |
| Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Within 7 Days after second vaccination | — |
| Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Within 7 Days after third vaccination | — |
| Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Within 7 Days after first vaccination | Here, N signifies participants with known values reporting specific characteristic. |
| Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Within 7 Days after second vaccination | Here, N signifies participants with known values reporting specific characteristic. |
| Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Within 7 Days after third vaccination | Here, N signifies participants with known values reporting specific characteristic. |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination | Within 30 days after first vaccination | — |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | — |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination | — |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination | Within 30 days after any vaccination | — |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase | From the first vaccination up to 1 month after the third vaccination | — |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase | From 1 month after third vaccination up to 6 months after the third vaccination | — |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period | From the first vaccination up to 6 month after the third vaccination | — |
| Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination | Within 30 days after first vaccination | — |
| Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination | Within 30 days after second vaccination | — |
| Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination | Within 30 days after third vaccination | — |
| Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination | Within 30 days after any vaccination | — |
| Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period | From the first vaccination up to 6 month after the third vaccination | — |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination | Within 30 days after first vaccination | — |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination | 30 days after second vaccination | — |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination | Within 30 days after third vaccination | — |
| Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination | Within 30 Days After any Vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before first vaccination, 1 month after third vaccination (Vac) | Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. |
| hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before first vaccination, 1 month after third vaccination | Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. |
| Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1 | Before vaccination 1, 1 Month after Vaccination 2 | Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. |
| Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 | One month after second Bivalent rLP2086 vaccination | Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. |
| Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | One month after second, third vaccination | — |
| hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | Before vaccination (Vac) 1, 1 Month after Vac 2 | — |
| Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vaccination (Vac) 1, 1 Month after Vac 2, 3 | — |
| Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vaccination (Vac) 1, 1 Month after Vac 2, 3 | Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination. |
| Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination | One month after third bivalent rLP2086 vaccination | — |
| Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | One month after third bivalent rLP2086 vaccination (Vac) | — |
| Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | Before first vaccination, 1 month after third vaccination | Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. |
Countries
Canada, Czechia, Finland, Germany, Italy, Poland, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 3596 participants were randomized in this study, out of which 3590 participants received vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 rLP2086 Lot 1 Lot 1 on a 0-, 2-, 6- month schedule. | 1,508 |
| Group 2 rLP2086 Lot 2 Lot 2 on a 0-, 2-, 6- month schedule | 598 |
| Group 3 rLP2086 Lot 3 Lot 3 on a 0-, 2-, 6- month schedule | 587 |
| Group 4 HAV/Saline Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2. | 897 |
| Total | 3,590 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 5 | 6 | 3 |
| Overall Study | Lost to Follow-up | 47 | 20 | 23 | 33 |
| Overall Study | Medication error without associated AE | 1 | 0 | 0 | 1 |
| Overall Study | No longer meets eligibility criteria | 11 | 2 | 3 | 5 |
| Overall Study | No longer willing to participate | 32 | 13 | 12 | 17 |
| Overall Study | Other | 7 | 1 | 4 | 4 |
| Overall Study | Pregnancy | 3 | 1 | 2 | 1 |
| Overall Study | Protocol deviation | 10 | 5 | 6 | 6 |
| Overall Study | Withdrawal by Subject | 33 | 14 | 10 | 12 |
Baseline characteristics
| Characteristic | Group 1 rLP2086 Lot 1 | Group 2 rLP2086 Lot 2 | Group 3 rLP2086 Lot 3 | Group 4 HAV/Saline | Total |
|---|---|---|---|---|---|
| Age, Continuous | 13.9 Years STANDARD_DEVIATION 2.6 | 14.0 Years STANDARD_DEVIATION 2.6 | 13.9 Years STANDARD_DEVIATION 2.6 | 13.9 Years STANDARD_DEVIATION 2.6 | 13.9 Years STANDARD_DEVIATION 2.6 |
| Sex: Female, Male Female | 737 Participants | 286 Participants | 274 Participants | 443 Participants | 1740 Participants |
| Sex: Female, Male Male | 771 Participants | 312 Participants | 313 Participants | 454 Participants | 1850 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1,410 / 1,508 | 547 / 598 | 542 / 587 | 655 / 897 |
| serious Total, serious adverse events | 22 / 1,508 | 10 / 598 | 19 / 587 | 22 / 897 |
Outcome results
Primary
hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine
Time frame: One month after third bivalent rLP2086 vaccination
Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine | PMB80[A22] (N= 1266, 518, 492) | 86.8 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine | PMB2948[B24] (N= 1250, 516, 479) | 24.1 titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine | PMB80[A22] (N= 1266, 518, 492) | 84.3 titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine | PMB2948[B24] (N= 1250, 516, 479) | 25.3 titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine | PMB80[A22] (N= 1266, 518, 492) | 85.1 titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine | PMB2948[B24] (N= 1250, 516, 479) | 25.2 titer |
Comparison: PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.95% CI: [0.93, 1.14]
Comparison: PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.95% CI: [0.92, 1.13]
Comparison: PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.95% CI: [0.88, 1.12]
Comparison: PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.95% CI: [0.85, 1.06]
Comparison: PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.95% CI: [0.86, 1.06]
Comparison: PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB294895% CI: [0.88, 1.14]
Primary
Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase | 3.9 days | Standard Deviation 6.56 |
| Group 2 rLP2086 Lot 2 | Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase | 4.0 days | Standard Deviation 5.19 |
Primary
Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination
Time frame: Within 30 minutes after first vaccination
Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination | 0.2 percentage of participants |
Primary
Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination
Time frame: Within 30 minutes after second vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination | 0.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination | 0.1 percentage of participants |
Primary
Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination
Time frame: Within 30 minutes after third vaccination
Population: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination | 0.0 percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
Time frame: Within 7 Days after first vaccination
Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination. Here,number of participants analyzed signifies participants with known values after the first vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Any | 86.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Mild | 5.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Moderate | 40.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Moderate | 8.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Mild | 8.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Severe | 1.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Severe | 5.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Any | 18.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Moderate | 8.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Mild | 41.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Severe | 0.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Any | 16.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Severe | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Mild | 1.8 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Any | 47.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Mild | 36.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Moderate | 9.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Pain at injection site: Severe | 0.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Any | 1.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Mild | 1.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Moderate | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Redness: Severe | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Moderate | 0.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination | Swelling: Any | 2.2 percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
Time frame: Within 7 Days after second vaccination
Population: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Any | 77.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Mild | 39.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Moderate | 33.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Severe | 5.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Any | 12.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Mild | 5.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Moderate | 6.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Severe | 1.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Any | 13.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Mild | 6.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Moderate | 7.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Severe | 0.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Moderate | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Any | 15.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Moderate | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Mild | 12.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Mild | 0.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Moderate | 2.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Severe | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Pain at injection site: Severe | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Severe | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Any | 0.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Swelling: Any | 0.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination | Redness: Mild | 0.6 percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
Time frame: Within 7 Days after third vaccination
Population: Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.Here,number of participants analyzed signifies participants with known values after third vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Moderate | 36.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Severe | 5.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Any | 76.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Mild | 34.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Any | 13.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Mild | 4.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Moderate | 6.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Severe | 2.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Any | 15.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Mild | 7.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Moderate | 6.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Severe | 0.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Moderate | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Moderate | 9.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Moderate | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Severe | 0.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Mild | 0.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Any | 34.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Severe | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Pain at injection site: Mild | 23.8 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Severe | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Any | 1.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Swelling: Any | 0.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination | Redness: Mild | 1.0 percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Here, N signifies participants with known values reporting specific characteristic.
Time frame: Within 7 Days after first vaccination
Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.Here,number of participants analyzed signifies participants with known values after the first vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Moderate(N=2681,890) | 0.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Moderate(N=2681,890) | 8.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever >=38 degrees C(N=2679, 890) | 6.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever 38 to <38.5 degreesC(N=2679, 890) | 4.0 percentage of participants |
| Group 1 rLP2086 Lot 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=2679, 890) | 1.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever 39 to 40 degrees C(N=2679, 890) | 0.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever >40 degrees C(N=2679, 890) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Any(N=2681,890) | 3.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Mild(N=2681,890) | 2.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Severe(N=2681,890) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Any(N=2681,890) | 10.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Mild(N=2681,890) | 9.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Moderate(N=2681,890) | 1.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Severe(N=2681,890) | 0.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Any(N=2681,890) | 51.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Mild(N=2681,890) | 28.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Moderate(N=2681,890) | 21.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Severe(N=2681,890) | 2.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Any(N=2681,890) | 54.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Mild(N=2681,890) | 27.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Moderate(N=2681,890) | 23.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Severe(N=2681,890) | 3.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Any(N=2681,890) | 25.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Mild(N=2681,890) | 16.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Severe(N=2681,890) | 1.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Any(N=2681,890) | 24.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Mild(N=2681,890) | 13.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Moderate(N=2681,890) | 10.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Severe(N=2681,890) | 1.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Any(N=2681,890) | 21.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Mild(N=2681,890) | 11.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Moderate(N=2681,890) | 8.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Severe(N=2681,890) | 1.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Antipyretic medication(N=2681,890) | 20.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Any(N=2681,890) | 19.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Severe(N=2681,890) | 0.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Antipyretic medication(N=2681,890) | 10.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever >=38 degrees C(N=2679, 890) | 1.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Any(N=2681,890) | 40.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever 38 to <38.5 degreesC(N=2679, 890) | 1.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Mild(N=2681,890) | 13.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever 38.5 to<39 degrees C(N=2679, 890) | 0.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Mild(N=2681,890) | 23.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever 39 to 40 degrees C(N=2679, 890) | 0.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Mild(N=2681,890) | 8.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fever >40 degrees C(N=2679, 890) | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Moderate(N=2681,890) | 15.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Any(N=2681,890) | 1.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Moderate(N=2681,890) | 5.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Mild(N=2681,890) | 1.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Mild(N=2681,890) | 13.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Moderate(N=2681,890) | 0.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Fatigue:Severe(N=2681,890) | 1.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Vomiting:Severe(N=2681,890) | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Severe(N=2681,890) | 0.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Any(N=2681,890) | 12.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Any(N=2681,890) | 17.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Mild(N=2681,890) | 10.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Muscle pain:Severe(N=2681,890) | 0.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Moderate(N=2681,890) | 1.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Moderate(N=2681,890) | 3.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Diarrhea:Severe(N=2681,890) | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Moderate(N=2681,890) | 4.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Any(N=2681,890) | 37.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Chills:Severe(N=2681,890) | 0.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Mild(N=2681,890) | 24.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Joint pain:Any(N=2681,890) | 13.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Headache:Moderate(N=2681,890) | 12.5 percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Here, N signifies participants with known values reporting specific characteristic.
Time frame: Within 7 Days after second vaccination
Population: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Severe(N=2545, 843) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever 38 to <38.5 degreesC(N=2540, 840) | 1.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever 38.5 to<39 degrees C(N=2540, 840) | 0.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever 39 to 40 degrees C(N=2540, 840) | 0.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever >40 degrees C(N=2540, 840) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Any(N=2545, 843) | 2.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Mild(N=2545, 843) | 1.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Moderate(N=2545, 843) | 0.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever >=38 degrees C(N=2540, 840) | 2.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Any(N=2545, 843) | 7.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Mild(N=2545, 843) | 6.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Moderate(N=2545, 843) | 1.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Severe(N=2545, 843) | 0.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Any(N=2545, 843) | 37.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Mild(N=2545, 843) | 20.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Moderate(N=2545, 843) | 16.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Severe(N=2545, 843) | 1.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Any(N=2545, 843) | 38.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Mild(N=2545, 843) | 20.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Moderate(N=2545, 843) | 15.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Severe(N=2545, 843) | 1.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Any(N=2545, 843) | 16.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Mild(N=2545, 843) | 10.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Moderate(N=2545, 843) | 4.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Severe(N=2545, 843) | 0.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Any(N=2545, 843) | 17.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Mild(N=2545, 843) | 8.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Moderate(N=2545, 843) | 7.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Severe(N=2545, 843) | 1.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Any(N=2545, 843) | 16.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Mild(N=2545, 843) | 8.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Moderate(N=2545, 843) | 7.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Severe(N=2545, 843) | 0.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Antipyretic medication(N=2545, 843) | 13.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Any(N=2545, 843) | 10.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever >=38 degrees C(N=2540, 840) | 1.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Any(N=2545, 843) | 26.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever 38 to <38.5 degreesC(N=2540, 840) | 0.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Antipyretic medication(N=2545, 843) | 8.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever 38.5 to<39 degrees C(N=2540, 840) | 0.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Mild(N=2545, 843) | 13.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever 39 to 40 degrees C(N=2540, 840) | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Mild(N=2545, 843) | 5.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fever >40 degrees C(N=2540, 840) | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Moderate(N=2545, 843) | 11.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Any(N=2545, 843) | 1.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Mild(N=2545, 843) | 5.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Mild(N=2545, 843) | 1.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Fatigue:Severe(N=2545, 843) | 1.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Moderate(N=2545, 843) | 0.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Moderate(N=2545, 843) | 4.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Vomiting:Severe(N=2545, 843) | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Any(N=2545, 843) | 10.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Any(N=2545, 843) | 9.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Severe(N=2545, 843) | 0.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Mild(N=2545, 843) | 7.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Mild(N=2545, 843) | 8.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Moderate(N=2545, 843) | 1.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Muscle pain:Severe(N=2545, 843) | 0.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Diarrhea:Severe(N=2545, 843) | 0.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Moderate(N=2545, 843) | 1.8 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Any(N=2545, 843) | 28.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Moderate(N=2545, 843) | 3.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Mild(N=2545, 843) | 15.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Chills:Severe(N=2545, 843) | 0.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Moderate(N=2545, 843) | 10.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Joint pain:Any(N=2545, 843) | 9.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Headache:Severe(N=2545, 843) | 1.5 percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Here, N signifies participants with known values reporting specific characteristic.
Time frame: Within 7 Days after third vaccination
Population: Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, number of participants analyzed signifies participants with known values after third vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Severe(N=2421, 821) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Any(N=2421, 821) | 7.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Moderate(N=2421, 821) | 3.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Severe(N=2421, 821) | 0.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever >=38 degrees C(N=2414, 819) | 2.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever 38 to <38.5degreesC(N=2414, 819) | 1.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever 38.5 to<39 degrees C(N=2414, 819) | 0.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever 39 to 40 degrees C(N=2414, 819) | 0.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever >40 degrees C(N=2414, 819) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Any(N=2421, 821) | 1.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Mild(N=2421, 821) | 1.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Moderate(N=2421, 821) | 0.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Mild(N=2421, 821) | 6.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Moderate(N=2421, 821) | 1.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Severe(N=2421, 821) | 0.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Any(N=2421, 821) | 35.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Mild(N=2421, 821) | 18.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Moderate(N=2421, 821) | 15.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Severe(N=2421, 821) | 1.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Any(N=2421, 821) | 35.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Mild(N=2421, 821) | 18.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Moderate(N=2421, 821) | 15.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Severe(N=2421, 821) | 2.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Any(N=2421, 821) | 13.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Mild(N=2421, 821) | 8.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Severe(N=2421, 821) | 0.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Any(N=2421, 821) | 17.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Mild(N=2421, 821) | 9.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Moderate(N=2421, 821) | 7.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Any(N=2421, 821) | 16.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Mild(N=2421, 821) | 8.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Moderate(N=2421, 821) | 5.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Severe(N=2421, 821) | 1.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Antipyretic medication(N=2421, 821) | 12.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Any(N=2421, 821) | 8.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Severe(N=2421, 821) | 0.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Mild(N=2421, 821) | 13.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Any(N=2421, 821) | 8.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Mild(N=2421, 821) | 6.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Severe(N=2421, 821) | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Chills:Moderate(N=2421, 821) | 1.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Moderate(N=2421, 821) | 4.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Moderate(N=2421, 821) | 10.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Antipyretic medication(N=2421, 821) | 6.8 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever >=38 degrees C(N=2414, 819) | 2.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Severe(N=2421, 821) | 1.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever 38 to <38.5degreesC(N=2414, 819) | 1.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Any(N=2421, 821) | 11.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever 38.5 to<39 degrees C(N=2414, 819) | 0.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Any(N=2421, 821) | 24.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever 39 to 40 degrees C(N=2414, 819) | 0.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Mild(N=2421, 821) | 5.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fever >40 degrees C(N=2414, 819) | 0.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Mild(N=2421, 821) | 13.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Any(N=2421, 821) | 2.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Mild(N=2421, 821) | 6.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Mild(N=2421, 821) | 1.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Moderate(N=2421, 821) | 10.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Vomiting:Moderate(N=2421, 821) | 0.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Any(N=2421, 821) | 7.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Severe(N=2421, 821) | 0.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Mild(N=2421, 821) | 6.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Fatigue:Severe(N=2421, 821) | 0.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Moderate(N=2421, 821) | 1.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Muscle pain:Severe(N=2421, 821) | 0.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Diarrhea:Severe(N=2421, 821) | 0.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Joint pain:Moderate(N=2421, 821) | 3.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Headache:Any(N=2421, 821) | 24.8 percentage of participants |
Primary
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.
Time frame: One month after third bivalent rLP2086 vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 | Composite hSBA response (N= 1170) | 83.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 | PMB80[A22] (N= 1225) | 83.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 | PMB2001[A56] (N= 1128) | 90.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 | PMB2948[B24] (N= 1235) | 79.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 | PMB2707[B44] (N= 1203) | 85.9 percentage of participants |
Primary
Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination | 9.51 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination | 10.70 percentage of participants |
Primary
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
Time frame: Within 30 days after second vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination | 11.48 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination | 12.67 percentage of participants |
Primary
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Population: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination | 9.91 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination | 10.78 percentage of participants |
Primary
Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase | 40.74 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase | 43.70 percentage of participants |
Primary
Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination
Time frame: Within 30 Days after any vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination | 25.32 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination | 26.76 percentage of participants |
Primary
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Population: Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase | 15.61 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase | 16.92 percentage of participants |
Primary
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase | 25.29 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase | 27.87 percentage of participants |
Primary
Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period
Time frame: From the first vaccination up to 6 month after the third vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period | 32.38 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period | 35.56 percentage of participants |
Primary
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
Time frame: Within 30 days after any vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination | 14.18 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination | 16.61 percentage of participants |
Primary
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination | 5.27 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination | 6.69 percentage of participants |
Primary
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
Time frame: Within 30 days after second vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination | 5.91 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination | 6.51 percentage of participants |
Primary
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Population: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination | 5.81 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination | 7.43 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Population: Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase | 0.20 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase | 0.60 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase | 0.37 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase | 0.56 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
Time frame: From the first vaccination up to 6 month after the third vaccination
Population: Safety population included all participants who received at least 1 dose of the investigational product and had safety information available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period | 0.56 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period | 1.11 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
Time frame: Within 30 Days After any Vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination | 0.19 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination | 0.22 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination | 0.00 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination | 0.11 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination
Time frame: 30 days after second vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination | 0.08 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination | 0.12 percentage of participants |
Primary
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Population: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination | 0.12 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination | 0.00 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Population: Safety population: all participants who had at least 1 dose investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase | 0.44 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase | 0.60 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase | 1.49 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase | 1.90 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
Time frame: From the first vaccination up to 6 month after the third vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period | 1.89 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period | 2.45 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
Time frame: Within 30 days after any vaccination
Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination | 0.78 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination | 0.89 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination | 0.26 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination | 0.33 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
Time frame: Within 30 days after second vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination | 0.23 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination | 0.23 percentage of participants |
Primary
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Population: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination | 0.32 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination | 0.36 percentage of participants |
Secondary
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination
Time frame: Before vaccination (Vac) 1, 1 Month after Vac 2
Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2001[A56]: Before Vac 1 (N=1135, 0, 0) | 8.4 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2707[B44]: 1 Month after Vac 2 (N=1204, 0, 0) | 17.1 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2948[B24]: Before Vac 1 (N=1264, 510, 486) | 4.5 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2001[A56]: 1 Month after Vac 2 (N=1222, 0, 0) | 131.2 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2707[B44]: Before Vac 1 (N=1230, 0, 0) | 4.3 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB80[A22]: 1 Month after Vac 2 (N=1263, 510, 487) | 50.4 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB80[A22]: Before Vac 1 (N=1238, 502, 479) | 12.6 titer |
| Group 1 rLP2086 Lot 1 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2948[B24]: 1 Month after Vac 2 (N=1216,499,470) | 14.3 titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2001[A56]: 1 Month after Vac 2 (N=1222, 0, 0) | NA titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB80[A22]: Before Vac 1 (N=1238, 502, 479) | 12.9 titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB80[A22]: 1 Month after Vac 2 (N=1263, 510, 487) | 47.7 titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2001[A56]: Before Vac 1 (N=1135, 0, 0) | NA titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2707[B44]: 1 Month after Vac 2 (N=1204, 0, 0) | NA titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2948[B24]: Before Vac 1 (N=1264, 510, 486) | 4.6 titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2948[B24]: 1 Month after Vac 2 (N=1216,499,470) | 14.5 titer |
| Group 2 rLP2086 Lot 2 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2707[B44]: Before Vac 1 (N=1230, 0, 0) | NA titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2948[B24]: Before Vac 1 (N=1264, 510, 486) | 4.6 titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB80[A22]: 1 Month after Vac 2 (N=1263, 510, 487) | 49.6 titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2707[B44]: Before Vac 1 (N=1230, 0, 0) | NA titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2948[B24]: 1 Month after Vac 2 (N=1216,499,470) | 15.2 titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB80[A22]: Before Vac 1 (N=1238, 502, 479) | 12.2 titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2001[A56]: 1 Month after Vac 2 (N=1222, 0, 0) | NA titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2001[A56]: Before Vac 1 (N=1135, 0, 0) | NA titer |
| Group 3 rLP2086 Lot 3 | hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination | PMB2707[B44]: 1 Month after Vac 2 (N=1204, 0, 0) | NA titer |
Secondary
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Time frame: Before first vaccination, 1 month after third vaccination
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 assay results for the given antigen or strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 rLP2086 Lot 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 for Group 1 | PMB1256[B03]:1 Month after Vaccination 3 (N= 279) | 51.7 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB866[B09]:Before Vaccination 1 (N= 277) | 5.2 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB866[B09]:1 Month after Vaccination 3 (N= 276) | 22.9 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB431[B15]:Before Vaccination 1 (N= 275) | 7.3 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB431[B15]:1 Month after Vaccination 3 (N= 281) | 47.7 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB648[B16]:Before Vaccination 1 (N= 276) | 4.7 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB648[B16]:1 Month after Vaccination 3 (N= 278) | 22.1 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB3175[A29]:Before Vaccination 1 (N= 269) | 5.7 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB3175[A29]:1 Month after Vaccination 3 (N= 278) | 93.5 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB3010[A06]:Before Vaccination 1 (N= 277) | 9.3 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB3010[A06]:1 Month after Vaccination 3 (N= 280) | 78.6 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB3040[A07]:Before Vaccination 1 (N= 269) | 11.4 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB3040[A07]:1 Month after Vaccination 3 (N= 280) | 63.5 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB824[A12]: Before Vaccination 1 (N= 280) | 8.4 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB824[A12]:1 Month after Vaccination 3 (N= 277) | 22.3 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB1672[A15]:Before Vaccination 1 (N= 270) | 5.9 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB1672[A15]:1 Month after Vaccination 3 (N= 266) | 31.0 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB1989[A19]:Before Vaccination 1 (N= 274) | 9.1 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB1989[A19]:1 Month after Vaccination 3 (N= 275) | 57.6 titer |
| Group 1 rLP2086 Lot 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 for Group 1 | PMB1256[B03]:Before Vaccination 1 (N= 280) | 4.5 titer |
Secondary
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination
Time frame: One month after third bivalent rLP2086 vaccination (Vac)
Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB80[A22]: 1 Month after Vac 3(N=1225, 501, 478) | 91.43 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2001[A56]: 1 Month after Vac 3(N=1128, 0, 0) | 95.04 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2948[B24]: 1 Month after Vac 3(N=1235, 507,472) | 81.05 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2707[B44]: 1 Month after Vac 3(N=1203, 0, 0) | 86.62 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2707[B44]: 1 Month after Vac 3(N=1203, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB80[A22]: 1 Month after Vac 3(N=1225, 501, 478) | 92.02 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2948[B24]: 1 Month after Vac 3(N=1235, 507,472) | 79.09 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2001[A56]: 1 Month after Vac 3(N=1128, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2707[B44]: 1 Month after Vac 3(N=1203, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2001[A56]: 1 Month after Vac 3(N=1128, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB2948[B24]: 1 Month after Vac 3(N=1235, 507,472) | 80.93 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination | PMB80[A22]: 1 Month after Vac 3(N=1225, 501, 478) | 93.51 percentage of participants |
Secondary
Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination
Time frame: One month after third bivalent rLP2086 vaccination
Population: Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.
Secondary
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination
Time frame: One month after second, third vaccination
Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB80[A22]:1Month after Vaccination 2 (N=493, 473) | 71.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB80[A22]:1Month after Vaccination 3 (N=501, 478) | 83.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB2948[B24]:1Month after Vaccination 2(N=490,463) | 56.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB2948[B24]:1Month after Vaccination 3(N=507,472) | 76.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB2948[B24]:1Month after Vaccination 3(N=507,472) | 78.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB80[A22]:1Month after Vaccination 2 (N=493, 473) | 74.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB2948[B24]:1Month after Vaccination 2(N=490,463) | 56.8 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination | PMB80[A22]:1Month after Vaccination 3 (N=501, 478) | 86.0 percentage of participants |
Secondary
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Time frame: One month after second Bivalent rLP2086 vaccination
Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 | PMB80[A22] (N=1223) | 73.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 | PMB2001[A56] (N=1122) | 84.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 | PMB2948[B24] (N=1201) | 56.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 | PMB2707[B44] (N=1197) | 55.9 percentage of participants |
Secondary
Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Time frame: Before vaccination 1, 1 Month after Vaccination 2
Population: Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1 | Before First Vaccination (N= 1088) | 1.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1 | 1 Month after Vaccination 2 (N= 1122) | 54.1 percentage of participants |
Secondary
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3175[A29] 1:32 (N=269) | 10.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3010[A06] 1:32 (N=277) | 6.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1989[A19] 1:32 (N=275) | 85.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3175[A29] 1:4 (N=269) | 19.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3175[A29] 1:4 (N=278) | 98.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3175[A29] 1:8 (N=269) | 17.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3175[A29] 1:8 (N=278) | 98.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3175[A29] 1:16 (N=269) | 16.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3175[A29] 1:16 (N=278) | 98.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3175[A29] 1:32 (N=278) | 97.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3175[A29] 1:64 (N=269) | 4.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3175[A29] 1:64 (N=278) | 86.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3175[A29] 1:128 (N=269) | 1.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3175[A29] 1:128 (N=278) | 52.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3010[A06] 1:4 (N=277) | 9.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3010[A06] 1:4 (N=280) | 96.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3010[A06] 1:8 (N=277) | 9.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3010[A06] 1:8 (N=280) | 96.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3010[A06] 1:16 (N=277) | 9.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3010[A06] 1:16 (N=280) | 95.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3010 [A06] 1:32 (N=280) | 93.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3010[A06] 1:64 (N=277) | 2.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3010[A06] 1:64 (N=280) | 78.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3010[A06] 1:128 (N=277) | 1.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3010[A06] 1:128 (N=280) | 44.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3040[A07] 1:4 (N=269) | 43.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3040[A07] 1:4 (N=280) | 96.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3040[A07] 1:8 (N=269) | 43.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3040[A07] 1:8 (N=280) | 96.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3040[A07] 1:16 (N=269) | 42.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3040[A07] 1:16 (N=280) | 96.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3040[A07] 1:32 (N=269) | 37.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3040[A07] 1:32 (N=280) | 93.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3040[A07] 1:64 (N=269) | 21.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3040[A07] 1:64 (N=280) | 78.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB3040[A07] 1:128 (N=269) | 5.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB3040[A07] 1:128 (N=280) | 30.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB824[A12] 1:4 (N=280) | 5.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB824[A12] 1:4 (N=277) | 77.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB824[A12] 1:8 (N=280) | 4.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB824[A12] 1:8 (N=277) | 77.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB824[A12] 1:16 (N=280) | 3.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB824[A12] 1:16 (N=277) | 75.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB824[A12] 1:32 (N=280) | 2.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB824[A12] 1:32 (N=277) | 51.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB824[A12] 1:64 (N=280) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB824[A12] 1:64 (N=277) | 19.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB824[A12] 1:128 (N=280) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB824[A12] 1:128 (N=277) | 1.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1672[A15] 1:4 (N=270) | 22.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1672[A15] 1:4 (N=266) | 87.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1672[A15] 1:8 (N=270) | 20.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1672[A15] 1:8 (N=266) | 87.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1672[A15] 1:16 (N=270) | 17.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1672[A15] 1:16 (N=266) | 85.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1672[A15] 1:32 (N=270) | 13.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1672[A15] 1:32 (N=266) | 71.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1672[A15] 1:64 (N=270) | 3.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1672[A15] 1:64 (N=266) | 40.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1672[A15] 1:128 (N=270) | 0.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1672[A15] 1:128 (N=266) | 10.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1989[A19] 1:4 (N=274) | 20.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1989[A19] 1:4 (N=275) | 93.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1989[A19] 1:8 (N=274) | 18.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1989[A19] 1:8 (N=275) | 93.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1989[A19] 1:16 (N=274) | 11.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1989[A19] 1:16 (N=275) | 92.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1989[A19] 1:32 (N=274) | 5.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1989[A19] 1:64 (N=274) | 1.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1989[A19] 1:64 (N=275) | 60.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1989[A19] 1:128 (N=274) | 0.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1989[A19] 1:128 (N=275) | 33.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1256[B03] 1:4 (N=280) | 5.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1256[B03] 1:4 (N=279) | 92.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1256[B03] 1:8 (N=280) | 4.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1256[B03] 1:8 (N=279) | 92.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1256[B03] 1:16 (N=280) | 4.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1256[B03] 1:16 (N=279) | 92.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1256[B03] 1:32 (N=280) | 3.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1256[B03] 1:32 (N=279) | 81.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1256[B03] 1:64 (N=280) | 2.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1256[B03] 1:64 (N=279) | 60.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB1256[B03] 1:128 (N=280) | 0.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB1256[B03] 1:128 (N=279) | 29.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB866[B09] 1:4 (N=277) | 15.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB866[B09] 1:4 (N=276) | 86.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB866[B09] 1:8 (N=277) | 15.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB866[B09] 1:8 (N=276) | 86.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB866[B09] 1:16 (N=277) | 13.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB866[B09] 1:16 (N=276) | 83.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB866[B09] 1:32 (N=277) | 8.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB866[B09] 1:32 (N=276) | 54.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB866[B09] 1:64 (N=277) | 0.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB866[B09] 1:64 (N=276) | 21.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB866[B09] 1:128 (N=277) | 0.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB866[B09] 1:128 (N=276) | 4.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB431[B15] 1:4 (N=275) | 30.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB431[B15] 1:4 (N=281) | 98.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB431[B15] 1:8 (N=275) | 28.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB431[B15] 1:8 (N=281) | 98.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB431[B15] 1:16 (N=275) | 27.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB431[B15] 1:16 (N=281) | 97.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB431[B15] 1:32 (N=275) | 21.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB431[B15] 1:32 (N=281) | 85.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB431[B15] 1:64 (N=275) | 8.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB431[B15] 1:64 (N=281) | 56.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB431[B15] 1:128 (N=275) | 0.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB431[B15] 1:128 (N=281) | 19.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB648[B16] 1:4 (N=276) | 8.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB648[B16] 1:4 (N=278) | 82.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB648[B16] 1:8 (N=276) | 7.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB648[B16] 1:8 (N=278) | 81.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB648[B16] 1:16 (N=276) | 7.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB648[B16] 1:16 (N=278) | 79.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB648[B16] 1:32 (N=276) | 6.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB648[B16] 1:32 (N=278) | 54.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB648[B16] 1:64 (N=276) | 1.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB648[B16] 1:64 (N=278) | 24.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | Before Vaccination 1: PMB648[B16] 1:128 (N=276) | 0.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 | 1 month after Vac 3: PMB648[B16] 1:128 (N=278) | 5.8 percentage of participants |
Secondary
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:128(N=1210,0,0) | 35.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:4(N=1229, 0, 0) | 99.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:32(N=1210,0,0) | 71.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:32(N=1250,516,479) | 52.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:16(N=1135, 0, 0) | 27.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2948[B24]1:32(N=1216,499,470) | 33.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:16(N=1222,0,0) | 99.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:4(N=1266, 518, 492) | 97.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:32(N=1264, 510, 486) | 2.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:16(N=1229,0,0) | 99.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:4(N=1135, 0, 0) | 29.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:16(N=1250,516,479) | 82.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] ] 1:32(N=1135, 0, 0) | 25.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56] 1:32(N=1222,0,0) | 97.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:32(N=1230, 0, 0) | 1.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2948[B24]1:16(N=1216,499,470) | 60.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:32(N=1229,0,0) | 98.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:8(N=1238, 502, 479) | 34.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:16(N=1264, 510, 486) | 5.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:64(N=1135, 0, 0) | 17.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:64(N=1210,0,0) | 54.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2948[B24]1:4(N=1250,516,479) | 88.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2001[A56]1:64(N=1222,0,0) | 89.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2707[B44]1:16(N=1210,0, 0) | 86.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:4(N=1264, 510, 486) | 6.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:8(N=1263, 510, 487) | 94.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2001[A56]1:128(N=1229,0,0) | 82.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:128(N=1135, 0, 0) | 6.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:64(N=1229,0,0) | 94.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:128(N=1222,0,0) | 63.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:16(N=1204,0,0) | 57.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:8(N=1266, 518, 492) | 97.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2948[B24]1:4(N=1216,499,470) | 69.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:16(N=1230, 0, 0) | 3.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:32(N=1238, 502, 479) | 20.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:128(N=1204,0,0) | 13.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:4(N=1210, 0,0) | 90.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:32(N=1263, 510,487) | 81.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:64(N=1204,0,0) | 23.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:4(N=1204, 0,0) | 66.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:32(N=1266,518,492) | 93.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:4(N=1222, 0, 0) | 99.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:4(N=1230, 0, 0) | 4.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:64(N=1238, 502, 479) | 8.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:64(N=1250,516,479) | 22.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac3:PMB2948[B24]1:128(N=1250,516,479) | 8.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:64(N=1263,510,487) | 51.8 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:32(N=1204,0,0) | 39.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:128(N=1216,499,470) | 6.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:64(N=1266,518,492) | 75.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB80[A22] 1:4(N=1238, 502, 479) | 36.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2948[B24] 1:128(N=1264, 510,486) | 0.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:128(N=1238, 502,479) | 2.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2707[B44] 1:128(N=1230, 0, 0) | 0.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:64(N=1216,499,470) | 15.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:128(N=1263,510,487) | 24.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2707[B44] 1:64(N=1230, 0, 0) | 0.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2948[B24] 1:64(N=1264, 510, 486) | 1.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:128(N=1266,518,492) | 48.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:4(N=1263, 510, 487) | 94.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:64(N=1238, 502, 479) | 9.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:16(N=1135, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] ] 1:32(N=1135, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2948[B24]1:4(N=1216,499,470) | 72.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2948[B24] 1:64(N=1264, 510, 486) | 1.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB80[A22] 1:4(N=1238, 502, 479) | 39.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:4(N=1263, 510, 487) | 93.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:4(N=1266, 518, 492) | 98.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:8(N=1238, 502, 479) | 39.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:8(N=1263, 510, 487) | 93.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:8(N=1266, 518, 492) | 98.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:32(N=1238, 502, 479) | 21.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:32(N=1263, 510,487) | 79.4 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:32(N=1266,518,492) | 92.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:128(N=1266,518,492) | 46.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:64(N=1263,510,487) | 49.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:64(N=1266,518,492) | 75.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:128(N=1238, 502,479) | 2.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:128(N=1263,510,487) | 23.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:4(N=1135, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:4(N=1222, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:4(N=1229, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:16(N=1222,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:16(N=1229,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56] 1:32(N=1222,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:32(N=1229,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:64(N=1135, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2001[A56]1:64(N=1222,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:64(N=1229,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:128(N=1135, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:128(N=1222,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2001[A56]1:128(N=1229,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:4(N=1264, 510, 486) | 10.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2948[B24]1:4(N=1250,516,479) | 89.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:16(N=1264, 510, 486) | 7.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2948[B24]1:16(N=1216,499,470) | 61.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:16(N=1250,516,479) | 81.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:32(N=1264, 510, 486) | 3.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2948[B24]1:32(N=1216,499,470) | 34.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:32(N=1250,516,479) | 54.8 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:64(N=1216,499,470) | 13.0 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:64(N=1250,516,479) | 27.5 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2948[B24] 1:128(N=1264, 510,486) | 0.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:128(N=1216,499,470) | 5.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac3:PMB2948[B24]1:128(N=1250,516,479) | 11.2 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:4(N=1230, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:4(N=1204, 0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:4(N=1210, 0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:16(N=1230, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:16(N=1204,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2707[B44]1:16(N=1210,0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:32(N=1230, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:32(N=1204,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:32(N=1210,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2707[B44] 1:64(N=1230, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:64(N=1204,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:64(N=1210,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2707[B44] 1:128(N=1230, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:128(N=1204,0,0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:128(N=1210,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:128(N=1263,510,487) | 24.4 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2948[B24] 1:64(N=1264, 510, 486) | 1.9 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:128(N=1238, 502,479) | 2.5 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2707[B44] 1:128(N=1230, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:64(N=1216,499,470) | 15.3 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:32(N=1210,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:64(N=1250,516,479) | 25.3 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:64(N=1266,518,492) | 73.6 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB80[A22] 1:4(N=1238, 502, 479) | 36.7 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2948[B24] 1:128(N=1264, 510,486) | 0.4 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:64(N=1263,510,487) | 51.5 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:4(N=1135, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:128(N=1216,499,470) | 7.0 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:64(N=1238, 502, 479) | 5.4 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1:PMB2707[B44] 1:64(N=1230, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac3:PMB2948[B24]1:128(N=1250,516,479) | 8.6 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:32(N=1266,518,492) | 93.1 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:16(N=1250,516,479) | 83.1 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:4(N=1230, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:32(N=1263, 510,487) | 80.7 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:128(N=1210,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:4(N=1204, 0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:32(N=1238, 502, 479) | 19.8 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:64(N=1204,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:4(N=1210, 0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:8(N=1266, 518, 492) | 98.4 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] ] 1:32(N=1135, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:16(N=1230, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:8(N=1263, 510, 487) | 95.5 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:128(N=1204,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:128(N=1135, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:16(N=1204,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:128(N=1222,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:64(N=1229,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:8(N=1238, 502, 479) | 34.7 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2001[A56]1:128(N=1229,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2001[A56]1:64(N=1222,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:64(N=1210,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:4(N=1264, 510, 486) | 9.5 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2948[B24]1:4(N=1216,499,470) | 74.0 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:64(N=1135, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2707[B44]1:16(N=1210,0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2948[B24]1:4(N=1250,516,479) | 91.6 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:32(N=1229,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:4(N=1266, 518, 492) | 98.4 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:16(N=1264, 510, 486) | 7.0 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56] 1:32(N=1222,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:4(N=1222, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2948[B24]1:16(N=1216,499,470) | 62.1 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:16(N=1229,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:32(N=1230, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:16(N=1222,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:128(N=1266,518,492) | 49.2 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24] 1:32(N=1264, 510, 486) | 3.7 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:16(N=1135, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:32(N=1204,0,0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB2948[B24]1:32(N=1216,499,470) | 35.5 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:4(N=1229, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB80[A22]1:4(N=1263, 510, 487) | 95.5 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac3:PMB2948[B24]1:32(N=1250,516,479) | 54.1 percentage of participants |
Secondary
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Time frame: Before first vaccination, 1 month after third vaccination
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB824[A12]:1 Month after Vaccination 3 (N= 277) | 75.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB1989[A19]:1 Month after Vaccination 3 (N= 275) | 92.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB3175[A29]:Before Vaccination 1 (N= 269) | 17.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB3175[A29]:1 Month after Vaccination 3 (N= 278) | 98.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB3010[A06]:Before Vaccination 1 (N= 277) | 9.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB3010[A06]:1 Month after Vaccination 3 (N= 280) | 95.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB3040[A07]:Before Vaccination 1 (N= 269) | 43.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB3040[A07]:1 Month after Vaccination 3 (N= 280) | 96.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB824[A12]: Before Vaccination 1 (N= 280) | 3.9 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB1672[A15]:Before Vaccination 1 (N= 270) | 20.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB1672[A15]:1 Month after Vaccination 3 (N= 266) | 87.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB1989[A19]:Before Vaccination 1 (N= 274) | 11.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB1256[B03]:Before Vaccination 1 (N= 280) | 4.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB1256[B03]:1 Month after Vaccination 3 (N= 279) | 92.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB866[B09]:Before Vaccination 1 (N= 277) | 15.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB866[B09]:1 Month after Vaccination 3 (N= 276) | 86.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB431[B15]:Before Vaccination 1 (N= 275) | 28.7 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB431[B15]:1 Month after Vaccination 3 (N= 281) | 98.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB648[B16]:Before Vaccination 1 (N= 276) | 7.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 | PMB648[B16]:1 Month after Vaccination 3 (N= 278) | 81.7 percentage of participants |
Secondary
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Population: Evaluable immunogenicity population. Here N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 rLP2086 Lot 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 | Before Vac 1: PMB80[A22] 1:16(N=1238, 502, 479) | 33.2 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB80[A22]1:16(N=1263,510,487) | 94.3 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:16(N=1266, 518,492) | 97.8 percentage of participants |
| Group 1 rLP2086 Lot 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 | Before Vac 1: PMB2001[A56] 1:8(N=1135, 0, 0) | 27.5 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:8(N=1222, 0, 0) | 99.1 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:8(N=1229, 0, 0) | 99.5 percentage of participants |
| Group 1 rLP2086 Lot 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 | Before Vac 1: PMB2948[B24]1:8(N=1264, 510, 486) | 6.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:8(N=1216,499,470) | 66.4 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac3:PMB2948[B24]1:8(N=1250,516,479) | 87.1 percentage of participants |
| Group 1 rLP2086 Lot 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 | Before Vac 1: PMB2707[B44] 1:8(N=1230, 0, 0) | 3.6 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:8(N=1204, 0, 0) | 64.0 percentage of participants |
| Group 1 rLP2086 Lot 1 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:8(N=1210, 0, 0) | 89.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:8(N=1210, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:16(N=1238, 502, 479) | 34.9 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24]1:8(N=1264, 510, 486) | 8.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac3:PMB2948[B24]1:8(N=1250,516,479) | 87.6 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB80[A22]1:16(N=1263,510,487) | 92.7 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:8(N=1229, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:8(N=1204, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:16(N=1266, 518,492) | 97.3 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:8(N=1216,499,470) | 70.1 percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:8(N=1222, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:8(N=1135, 0, 0) | NA percentage of participants |
| Group 2 rLP2086 Lot 2 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:8(N=1230, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2001[A56] 1:8(N=1135, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2001[A56]1:8(N=1222, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2707[B44] 1:8(N=1230, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2001[A56]1:8(N=1229, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB2948[B24]1:8(N=1264, 510, 486) | 8.4 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac2:PMB2948[B24]1:8(N=1216,499,470) | 70.2 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac2:PMB2707[B44]1:8(N=1204, 0, 0) | NA percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | Before Vac 1: PMB80[A22] 1:16(N=1238, 502, 479) | 31.7 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month afterVac2:PMB80[A22]1:16(N=1263,510,487) | 94.7 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 monthafterVac3:PMB2948[B24]1:8(N=1250,516,479) | 90.0 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB80[A22]1:16(N=1266, 518,492) | 98.2 percentage of participants |
| Group 3 rLP2086 Lot 3 | Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination | 1 month after Vac3:PMB2707[B44]1:8(N=1210, 0, 0) | NA percentage of participants |