Meningitis, Meningococcal
Conditions
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
Interventions
BIOLOGICALmeningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
OTHERnormal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment. * Negative urine pregnancy test for all female subjects. * Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion criteria
* History of any invasive meningococcal disease. * A previous anaphylactic or severe vaccine-associated adverse reaction. * Any clinically significant chronic disease. * A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed. * Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Before vaccination 1 up to 1 month after vaccination 2 |
| Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Before vaccination 1 up to 1 month after vaccination 3 |
| Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Vaccination 1 upto 1 Month after vaccination 3 |
| Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 | 6 month after vaccination 3 up to 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | 1 month before vaccination 1, 1 month after vaccination 2, 3 |
Other
| Measure | Time frame |
|---|---|
| Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3 |
Countries
Australia, Poland, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. | 121 |
| rLP2086 60 mcg Given on a 0, 2-, 6-month schedule in Stage 1. | 22 |
| rLP2086 120 mcg Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. | 198 |
| rLP2086 200 mcg Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. | 198 |
| Total | 539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Stage 1 (6 Months) | Adverse Event | 0 | 0 | 1 | 2 |
| Stage 1 (6 Months) | Lost to Follow-up | 1 | 0 | 1 | 0 |
| Stage 1 (6 Months) | Other | 1 | 0 | 2 | 4 |
| Stage 1 (6 Months) | Parent/legal guardian request | 0 | 1 | 1 | 3 |
| Stage 1 (6 Months) | Protocol Violation | 0 | 0 | 0 | 1 |
| Stage 1 (6 Months) | Withdrawal by Subject | 3 | 0 | 2 | 5 |
| Stage 2 (Followed up to 48 Months ) | Adverse Event | 1 | 0 | 1 | 0 |
| Stage 2 (Followed up to 48 Months ) | Death | 0 | 0 | 1 | 0 |
| Stage 2 (Followed up to 48 Months ) | Failed to return | 2 | 0 | 5 | 4 |
| Stage 2 (Followed up to 48 Months ) | Lost to Follow-up | 2 | 0 | 8 | 7 |
| Stage 2 (Followed up to 48 Months ) | Non-compliance | 0 | 0 | 1 | 0 |
| Stage 2 (Followed up to 48 Months ) | Other | 0 | 0 | 1 | 1 |
| Stage 2 (Followed up to 48 Months ) | Parent's or guardian request | 0 | 0 | 2 | 0 |
| Stage 2 (Followed up to 48 Months ) | Protocol Violation | 0 | 0 | 1 | 0 |
| Stage 2 (Followed up to 48 Months ) | Withdrawal by Subject | 6 | 0 | 9 | 11 |
Baseline characteristics
| Characteristic | Control | rLP2086 60 mcg | rLP2086 120 mcg | rLP2086 200 mcg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 13.8 Years STANDARD_DEVIATION 2.05 | 13.3 Years STANDARD_DEVIATION 1.84 | 14.3 Years STANDARD_DEVIATION 2.11 | 14.0 Years STANDARD_DEVIATION 2.01 | 14.0 Years STANDARD_DEVIATION 2.05 |
| Sex: Female, Male Female | 61 Participants | 11 Participants | 113 Participants | 103 Participants | 288 Participants |
| Sex: Female, Male Male | 60 Participants | 11 Participants | 85 Participants | 95 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 54 / 121 | 18 / 22 | 75 / 198 | 91 / 195 | 5 / 121 | 3 / 22 | 2 / 198 | 4 / 195 | 1 / 80 | 1 / 170 | 0 / 151 |
| serious Total, serious adverse events | 3 / 121 | 1 / 22 | 3 / 198 | 8 / 195 | 0 / 121 | 1 / 22 | 1 / 198 | 2 / 195 | 1 / 80 | 6 / 170 | 3 / 151 |
Outcome results
Primary
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Time frame: Before vaccination 1 up to 1 month after vaccination 2
Population: mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control-Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily A Strain A05 (N= 80, 18, 115, 106) | 1.3 Percentage of participants |
| Control-Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily B Strain B02 (N= 84, 21, 121, 114) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily B Strain B02 (N= 84, 21, 121, 114) | 71.4 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily A Strain A05 (N= 80, 18, 115, 106) | 88.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily A Strain A05 (N= 80, 18, 115, 106) | 83.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily B Strain B02 (N= 84, 21, 121, 114) | 59.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily A Strain A05 (N= 80, 18, 115, 106) | 87.7 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 | Subfamily B Strain B02 (N= 84, 21, 121, 114) | 59.6 Percentage of participants |
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: >0.9999Binomial Distribution
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: 0.0007Binomial Distribution
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: <0.0001Binomial Distribution
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: <0.0001Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: >0.9999Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: 0.0392Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: 0.0225Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: 0.0244Binomial Distribution
Primary
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Time frame: Before vaccination 1 up to 1 month after vaccination 3
Population: mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control-Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily A Strain A05 (N= 73, 19, 111,100) | 5.5 Percentage of participants |
| Control-Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily B Strain B02 (N= 79, 21, 112,105) | 1.3 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily B Strain B02 (N= 79, 21, 112,105) | 81.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily A Strain A05 (N= 73, 19, 111,100) | 89.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily A Strain A05 (N= 73, 19, 111,100) | 92.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily B Strain B02 (N= 79, 21, 112,105) | 86.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily A Strain A05 (N= 73, 19, 111,100) | 94.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 | Subfamily B Strain B02 (N= 79, 21, 112,105) | 84.8 Percentage of participants |
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: >0.9999Binomial Distribution
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: 0.0004Binomial Distribution
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: <0.0001Binomial Distribution
Comparison: Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: <0.0001Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: >0.9999Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: 0.0036Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: <0.0001Binomial Distribution
Comparison: Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.p-value: <0.0001Binomial Distribution
Primary
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Time frame: Vaccination 1 upto 1 Month after vaccination 3
Population: Safety population included participants who received at least 1 dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control-Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: Vaccination phase | 44.6 Percentage of participants |
| Control-Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: 6-month follow up phase | 4.1 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: 6-month follow up phase | 18.2 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: Vaccination phase | 81.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: Vaccination phase | 38.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: 6-month follow up phase | 1.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: Vaccination phase | 47.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 | Stage 1: 6-month follow up phase | 2.6 Percentage of participants |
Primary
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Time frame: 6 month after vaccination 3 up to 48 months
Population: Safety population included participants who received at least 1 dose of study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control-Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 | 2.5 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 | 4.1 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 | 2.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
Time frame: 1 month before vaccination 1, 1 month after vaccination 2, 3
Population: mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:32 (N= 64, 15, 90, 92) | 10.9 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:64 (N= 64, 15, 90, 92) | 3.1 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:128 (N= 64, 15, 90, 92) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:32 (N= 69, 21, 115, 115) | 4.3 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:64 (N= 69, 21, 115, 115) | 1.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:128 (N= 69, 21, 115, 115) | 1.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:16 (N= 81, 21, 122, 114) | 12.3 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:32 (N= 81, 21, 122, 114) | 7.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:64 (N= 81, 21, 122, 114) | 4.9 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:128 (N= 81, 21, 122, 114) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:16 (N= 83, 18, 118, 110) | 7.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:32 (N= 83, 18, 118, 110) | 3.6 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:64 (N= 83, 18, 118, 110) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:128 (N= 83, 18, 118, 110) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:16 (N= 76, 20, 114, 104) | 11.8 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:32 (N= 76, 20, 114, 104) | 7.9 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:64 (N= 76, 20, 114, 104) | 3.9 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:128 (N= 76, 20, 114, 104) | 1.3 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:16 (N= 80, 21, 119, 115) | 10.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:32 (N= 80, 21, 119, 115) | 7.5 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:64 (N= 80, 21, 119, 115) | 2.5 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:128 (N= 80, 21, 119, 115) | 1.3 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:16 (N= 81, 20, 117, 107) | 12.3 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:32 (N= 81, 20, 117, 107) | 11.1 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:64 (N= 81, 20, 117, 107) | 9.9 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:128 (N= 81, 20, 117, 107) | 2.5 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:16 (N= 78, 21, 114, 112) | 11.5 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:32 (N= 78, 21, 114, 112) | 9.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:64 (n= 78, 21, 114, 112) | 3.8 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3;1:128 (N= 78, 21, 114, 112) | 2.6 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:16 (N= 84, 22, 124, 118) | 3.6 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:32 (N= 84, 22, 124, 118) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:64 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:128 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:16 (N= 84, 21, 122, 114) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:32 (N= 84, 21, 122, 114) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:64 (N= 84, 21, 122, 114) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2;1:128 (N= 84, 21, 122, 114) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:16 (N= 79, 21, 113, 105) | 3.8 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:32 (N= 79, 21, 113, 105) | 1.3 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:64 (N= 79, 21, 113, 105) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3;1:128 (N= 79, 21, 113, 105) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:16 (N= 83, 22, 118, 117) | 2.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:32 (N= 83, 22, 118, 117) | 2.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:64 (N= 83, 22, 118, 117) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:128 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:16 (N= 84, 19, 102, 96) | 2.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:32 (N= 84, 19, 102, 96) | 2.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:64 (N= 84, 19, 102, 96) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:128 (N= 84, 19, 102, 96) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:16 (N= 68, 15, 86, 81) | 5.9 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:32 (N= 68, 15, 86, 81) | 4.4 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:64 (N= 68, 15, 86, 81) | 1.5 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:128 (N= 68, 15, 86, 81) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:8 (N= 81, 22, 120, 116) | 2.5 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:16 (N= 81, 22, 120, 116) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:32 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:64 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:128 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:8 (n= 81, 21, 115, 106) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:16 (N= 81, 21, 115, 106) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:32 (N= 81, 21, 115, 106) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:64 (N= 81, 21, 115, 106) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:128 (N= 81, 21, 115, 106) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:8 (N= 83, 21, 115, 111) | 4.8 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3; 1:16 (N= 83, 21, 115, 111) | 1.2 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:32 (N= 83, 21, 115, 111) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:64 (N= 83, 21, 115, 111) | 0.0 Percentage of participants |
| Control-Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:128 (N= 83, 21, 115, 111) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:32 (N= 83, 18, 118, 110) | 88.9 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:32 (N= 68, 15, 86, 81) | 53.3 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:32 (N= 80, 21, 119, 115) | 4.8 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:32 (N= 84, 21, 122, 114) | 57.1 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:32 (N= 81, 20, 117, 107) | 85.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:16 (N= 68, 15, 86, 81) | 53.3 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:8 (N= 83, 21, 115, 111) | 76.2 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:64 (N= 84, 21, 122, 114) | 42.9 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:128 (N= 76, 20, 114, 104) | 40.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:128 (N= 84, 19, 102, 96) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:16 (N= 83, 18, 118, 110) | 88.9 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2;1:128 (N= 84, 21, 122, 114) | 14.3 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:8 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:64 (N= 84, 19, 102, 96) | 5.3 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:32 (N= 81, 21, 115, 106) | 47.6 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:16 (N= 79, 21, 113, 105) | 85.7 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:64 (N= 81, 20, 117, 107) | 80.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:32 (N= 84, 19, 102, 96) | 21.1 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:16 (N= 80, 21, 119, 115) | 4.8 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:32 (N= 79, 21, 113, 105) | 81.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:128 (N= 81, 21, 122, 114) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:16 (N= 84, 19, 102, 96) | 21.1 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:128 (N= 81, 21, 115, 106) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:64 (N= 79, 21, 113, 105) | 57.1 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:32 (N= 83, 21, 115, 111) | 76.2 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:128 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:64 (N= 83, 21, 115, 111) | 47.6 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3;1:128 (N= 79, 21, 113, 105) | 42.9 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:128 (N= 81, 20, 117, 107) | 45.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:64 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:64 (N= 81, 21, 115, 106) | 23.8 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:16 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:16 (N= 76, 20, 114, 104) | 90.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:32 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3; 1:16 (N= 83, 21, 115, 111) | 76.2 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:128 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:16 (N= 78, 21, 114, 112) | 95.2 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:16 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:64 (N= 81, 21, 122, 114) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:64 (N= 80, 21, 119, 115) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:32 (N= 78, 21, 114, 112) | 85.7 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:64 (N= 76, 20, 114, 104) | 85.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:32 (N= 81, 21, 122, 114) | 4.8 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:16 (N= 81, 21, 122, 114) | 4.8 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:64 (n= 78, 21, 114, 112) | 71.4 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:128 (N= 83, 18, 118, 110) | 33.3 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:128 (N= 68, 15, 86, 81) | 26.7 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:128 (N= 83, 21, 115, 111) | 9.5 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3;1:128 (N= 78, 21, 114, 112) | 61.9 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:128 (N= 80, 21, 119, 115) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:128 (N= 69, 21, 115, 115) | 52.4 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:8 (n= 81, 21, 115, 106) | 61.9 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:16 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:32 (N= 76, 20, 114, 104) | 90.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:64 (N= 69, 21, 115, 115) | 85.7 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:64 (N= 83, 18, 118, 110) | 83.3 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:32 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:64 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:32 (N= 69, 21, 115, 115) | 95.2 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:128 (N= 64, 15, 90, 92) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:64 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:16 (N= 81, 20, 117, 107) | 85.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:64 (N= 68, 15, 86, 81) | 46.7 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:64 (N= 64, 15, 90, 92) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:128 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:32 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:32 (N= 64, 15, 90, 92) | 0.0 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:16 (N= 81, 21, 115, 106) | 61.9 Percentage of participants |
| rLP2086 60 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:16 (N= 84, 21, 122, 114) | 76.2 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:32 (N= 81, 20, 117, 107) | 90.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:128 (N= 76, 20, 114, 104) | 68.4 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:16 (N= 80, 21, 119, 115) | 7.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:32 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:32 (N= 80, 21, 119, 115) | 5.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:64 (N= 80, 21, 119, 115) | 0.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:128 (N= 80, 21, 119, 115) | 0.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:16 (N= 81, 20, 117, 107) | 94.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:64 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:64 (N= 81, 20, 117, 107) | 80.3 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:128 (N= 81, 20, 117, 107) | 39.3 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:16 (N= 78, 21, 114, 112) | 97.4 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:128 (N= 81, 22, 120, 116) | 0.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:32 (N= 78, 21, 114, 112) | 93.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:64 (n= 78, 21, 114, 112) | 91.2 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:32 (N= 83, 21, 115, 111) | 80.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3;1:128 (N= 78, 21, 114, 112) | 74.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:16 (N= 84, 22, 124, 118) | 1.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:8 (n= 81, 21, 115, 106) | 68.7 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:32 (N= 84, 22, 124, 118) | 0.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:64 (N= 84, 22, 124, 118) | 0.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:128 (N= 84, 22, 124, 118) | 0.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:16 (N= 84, 21, 122, 114) | 68.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:16 (N= 81, 21, 115, 106) | 60.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:32 (N= 84, 21, 122, 114) | 45.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:64 (N= 84, 21, 122, 114) | 25.4 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:128 (N= 83, 21, 115, 111) | 22.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2;1:128 (N= 84, 21, 122, 114) | 7.4 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:16 (N= 79, 21, 113, 105) | 90.3 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:32 (N= 81, 21, 115, 106) | 43.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:32 (N= 79, 21, 113, 105) | 78.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:64 (N= 79, 21, 113, 105) | 52.2 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3;1:128 (N= 79, 21, 113, 105) | 19.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:16 (N= 83, 22, 118, 117) | 2.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:64 (N= 81, 21, 115, 106) | 22.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:32 (N= 83, 22, 118, 117) | 2.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:64 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:64 (N= 83, 21, 115, 111) | 53.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:128 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:16 (N= 84, 19, 102, 96) | 32.4 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:128 (N= 81, 21, 115, 106) | 6.1 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:32 (N= 84, 19, 102, 96) | 30.4 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:64 (N= 84, 19, 102, 96) | 22.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:128 (N= 84, 19, 102, 96) | 10.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:16 (N= 68, 15, 86, 81) | 75.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:8 (N= 83, 21, 115, 111) | 88.7 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:32 (N= 68, 15, 86, 81) | 75.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:32 (N= 64, 15, 90, 92) | 10.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:64 (N= 64, 15, 90, 92) | 7.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:128 (N= 64, 15, 90, 92) | 1.1 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:64 (N= 68, 15, 86, 81) | 60.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:32 (N= 69, 21, 115, 115) | 98.3 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:64 (N= 69, 21, 115, 115) | 82.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:128 (N= 69, 21, 115, 115) | 44.3 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:16 (N= 81, 21, 122, 114) | 9.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:128 (N= 68, 15, 86, 81) | 27.9 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:32 (N= 81, 21, 122, 114) | 5.7 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:64 (N= 81, 21, 122, 114) | 2.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:128 (N= 81, 21, 122, 114) | 0.8 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:16 (N= 83, 18, 118, 110) | 89.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:8 (N= 81, 22, 120, 116) | 3.3 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:32 (N= 83, 18, 118, 110) | 85.6 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:64 (N= 83, 18, 118, 110) | 59.3 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3; 1:16 (N= 83, 21, 115, 111) | 86.1 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:128 (N= 83, 18, 118, 110) | 28.0 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:16 (N= 76, 20, 114, 104) | 96.5 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:16 (N= 81, 22, 120, 116) | 1.7 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:32 (N= 76, 20, 114, 104) | 94.7 Percentage of participants |
| rLP2086 120 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:64 (N= 76, 20, 114, 104) | 89.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:32 (N= 68, 15, 86, 81) | 66.7 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:128 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:32 (N= 83, 18, 118, 110) | 81.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:32 (N= 64, 15, 90, 92) | 12.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:8 (N= 83, 21, 115, 111) | 86.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:32 (N= 83, 21, 115, 111) | 80.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:8 (N= 81, 22, 120, 116) | 2.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:64 (N= 64, 15, 90, 92) | 5.4 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:64 (N= 84, 22, 124, 118) | 0.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:8 (n= 81, 21, 115, 106) | 70.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:128 (N= 80, 21, 119, 115) | 0.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 Predose 1;1:128 (N= 64, 15, 90, 92) | 0.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:64 (N= 76, 20, 114, 104) | 87.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:32 (N= 84, 22, 124, 118) | 1.7 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:64 (N= 83, 18, 118, 110) | 64.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:32 (N= 69, 21, 115, 115) | 91.3 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:64 (N= 68, 15, 86, 81) | 58.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 postdose 1;1:16 (N= 84, 22, 124, 118) | 2.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:32 (N= 76, 20, 114, 104) | 95.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:64 (N= 69, 21, 115, 115) | 72.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:128 (N= 83, 21, 115, 111) | 19.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3;1:128 (N= 78, 21, 114, 112) | 67.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:64 (N= 80, 21, 119, 115) | 3.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A04 1-month postdose 2;1:128 (N= 69, 21, 115, 115) | 42.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:64 (n= 78, 21, 114, 112) | 84.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:128 (N= 81, 22, 120, 116) | 0.9 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:16 (N= 81, 22, 120, 116) | 2.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:16 (N= 81, 21, 122, 114) | 6.1 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:128 (N= 83, 18, 118, 110) | 40.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:32 (N= 78, 21, 114, 112) | 93.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:32 (N= 81, 22, 120, 116) | 1.7 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:32 (N= 81, 21, 122, 114) | 4.4 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:128 (N= 68, 15, 86, 81) | 24.7 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 3 ;1:16 (N= 78, 21, 114, 112) | 95.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:32 (N= 80, 21, 119, 115) | 4.3 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:16 (N= 83, 22, 118, 117) | 2.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:64 (N= 81, 21, 122, 114) | 1.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:32 (N= 83, 22, 118, 117) | 2.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:64 (N= 81, 21, 115, 106) | 25.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3;1:128 (N= 79, 21, 113, 105) | 19.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:128 (N= 81, 20, 117, 107) | 45.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:64 (N= 83, 22, 118, 117) | 0.9 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:64 (N= 81, 20, 117, 107) | 71.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:64 (N= 79, 21, 113, 105) | 60.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:128 (N= 76, 20, 114, 104) | 60.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 Predose 1;1:128 (N= 83, 22, 118, 117) | 0.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:32 (N= 81, 21, 115, 106) | 42.5 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:32 (N= 79, 21, 113, 105) | 79.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 Predose 1;1:128 (N= 81, 21, 122, 114) | 0.0 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:16 (N= 84, 19, 102, 96) | 30.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 Predose 1 ;1:64 (N= 81, 22, 120, 116) | 0.9 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 3 ;1:16 (N= 79, 21, 113, 105) | 85.7 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:32 (N= 81, 20, 117, 107) | 88.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:32 (N= 84, 19, 102, 96) | 28.1 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:128 (N= 81, 21, 115, 106) | 11.3 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2;1:128 (N= 84, 21, 122, 114) | 8.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 3;1:16 (N= 76, 20, 114, 104) | 96.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:64 (N= 84, 19, 102, 96) | 19.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3;1:64 (N= 83, 21, 115, 111) | 61.3 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:64 (N= 84, 21, 122, 114) | 21.9 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A05 1-month postdose 2;1:16 (N= 83, 18, 118, 110) | 90.9 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 2;1:128 (N= 84, 19, 102, 96) | 2.3 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 2;1:16 (N= 81, 21, 115, 106) | 64.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:32 (N= 84, 21, 122, 114) | 48.2 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B44 1-month postdose 3; 1:16 (N= 83, 21, 115, 111) | 85.6 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B03 1-month postdose 3;1:16 (N= 68, 15, 86, 81) | 67.9 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 1-month postdose 2;1:16 (N= 81, 20, 117, 107) | 96.3 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | B02 1-month postdose 2 ;1:16 (N= 84, 21, 122, 114) | 65.8 Percentage of participants |
| rLP2086 200 mcg- Stage 1 | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level | A56 Predose 1;1:16 (N= 80, 21, 119, 115) | 6.1 Percentage of participants |
Other Pre-specified
Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B
Time frame: Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3
Population: mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Control-Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 3(N=98,20,158,148) | 4.1 Titer |
| Control-Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B Predose 1(N= 106,22,155,172) | 3.5 Titer |
| Control-Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 2(N=104, 22,168,166) | 4.9 Titer |
| Control-Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 3(N=98,20, 158,148) | 5.8 Titer |
| Control-Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 2(N=104, 22,168,166) | 3.7 Titer |
| Control-Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Subfamily(Sf) A Predose 1(N=106,22,156,173) | 3.6 Titer |
| rLP2086 60 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 2(N=104, 22,168,166) | 405.8 Titer |
| rLP2086 60 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 3(N=98,20,158,148) | 3264.2 Titer |
| rLP2086 60 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 2(N=104, 22,168,166) | 984.6 Titer |
| rLP2086 60 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Subfamily(Sf) A Predose 1(N=106,22,156,173) | 4.3 Titer |
| rLP2086 60 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 3(N=98,20, 158,148) | 3120.3 Titer |
| rLP2086 60 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B Predose 1(N= 106,22,155,172) | 4.2 Titer |
| rLP2086 120 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Subfamily(Sf) A Predose 1(N=106,22,156,173) | 7.2 Titer |
| rLP2086 120 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 2(N=104, 22,168,166) | 1115.5 Titer |
| rLP2086 120 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 2(N=104, 22,168,166) | 816.5 Titer |
| rLP2086 120 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B Predose 1(N= 106,22,155,172) | 5.4 Titer |
| rLP2086 120 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 3(N=98,20,158,148) | 2246.8 Titer |
| rLP2086 120 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 3(N=98,20, 158,148) | 2289.5 Titer |
| rLP2086 200 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 3(N=98,20,158,148) | 2553.3 Titer |
| rLP2086 200 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Subfamily(Sf) A Predose 1(N=106,22,156,173) | 4.9 Titer |
| rLP2086 200 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 2(N=104, 22,168,166) | 1285.8 Titer |
| rLP2086 200 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf A 1-month postdose 3(N=98,20, 158,148) | 2342.6 Titer |
| rLP2086 200 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B Predose 1(N= 106,22,155,172) | 3.9 Titer |
| rLP2086 200 mcg- Stage 1 | Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B | Sf B 1-month postdose 2(N=104, 22,168,166) | 852.0 Titer |