A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01352845

Acronym

B1971016

Enrollment

3301

Registered

2011-05-12

Start date

2013-05-31

Completion date

2015-02-28

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Interventions

BIOLOGICALrLP2086

0.5 mL dose, given at 0, 2 and 6 months

OTHERPlacebo

0.5 mL dose, given at 0, 2 and 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

1. Male or female subject aged \>=18 and \<26 years at the time of enrollment. 2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 3. Negative urine pregnancy test for all female subjects.

Exclusion criteria

1. Previous vaccination with any meningococcal serogroup B vaccine. 2. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination. 3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 4. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study. 5. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 6. Current chronic use of systemic antibiotics. 7. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination. 8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Design outcomes

Primary

Measure	Time frame	Description
Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase	From the first vaccination up to 1 month after the third vaccination	—
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase	From 1 month after third vaccination up to 6 months after the third vaccination	—
Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period	From the first vaccination up to 6 month after the third vaccination	—
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination	Within 30 days after first vaccination	—
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination	Within 30 days after any vaccination	—
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase	From the first vaccination up to 1 month after the third vaccination	—
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase	From 1 month after third vaccination up to 6 months after the third vaccination	—
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period	From the first vaccination up to 6 month after the third vaccination the third vaccination	—
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination	Within 30 minutes after first vaccination	—
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination	Within 30 minutes after second vaccination	—
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination	Within 30 minutes after third vaccination	—
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination	Within 30 days after third vaccination	—
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	One month after third bivalent rLP2086 vaccination	Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Within 7 days after first vaccination	—
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Within 7 days after second vaccination	—
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Within 7 days after third vaccination	—
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Within 7 days after first vaccination	—
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Within 7 days after second vaccination	—
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Within 7 days after third vaccination	—
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination	Within 30 days after first vaccination	—
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination	Within 30 days after second vaccination	—
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination	Within 30 days after third vaccination	—
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination	Within 30 days after any vaccination	—
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase	From the first vaccination up to 1 month after the third vaccination	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination	Within 30 days after first vaccination	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination	Within 30 days after second vaccination	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination	Within 30 days after third vaccination	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination	Within 30 days after any vaccination	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase	From 1 month after third vaccination up to 6 months after the third vaccination	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase	From the first vaccination up to 1 month after the third vaccination	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period	From the first vaccination up to 6 month after the third vaccination	—
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination	Within 30 days after first vaccination	—
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination	Within 30 days after second vaccination	—
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination	Within 30 days after second vaccination	—
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination	Within 30 days after third vaccination	—
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination	Within 30 days after any vaccination	—
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase	From the first vaccination up to 1 month after the third vaccination	—

Secondary

Measure	Time frame	Description
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before first vaccination, 1 month after third vaccination (Vac)	—
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before first vaccination, 1 month after third vaccination	—
Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1	Before vaccination 1, 1 Month after Vaccination 2	—
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1	One month after second Bivalent rLP2086 vaccination	—
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination (Vac) 1, 1 Month after Vac 2, 3	—
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination (Vac) 1, 1 Month after Vac 2, 3	Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary endpoint 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1'.
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination (Vac) 1, 1 Month after Vac 2, 3	—
Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination	One month after third bivalent rLP2086 vaccination	—
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	One month after third bivalent rLP2086 vaccination	—
Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	Before first vaccination, 1 month after third vaccination	—

Countries

Canada, Denmark, Finland, Poland, Spain, United States

Participant flow

Pre-assignment details

A total of 3304 participants were randomized in this study, out of which 3293 participants received vaccination.

Participants by arm

Arm	Count
Group 1 rLP2086 Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	2,471
Group 2 Saline Saline on a 0-, 2-, 6- month schedule.	822
Total	3,293

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	22	6
Overall Study	Death	3	0
Overall Study	Lost to Follow-up	313	92
Overall Study	No Longer Meets Eligibility Criteria	24	11
Overall Study	No Longer Willing to Participate	205	58
Overall Study	Other	17	7
Overall Study	Pregnancy	27	7
Overall Study	Protocol Violation	12	6
Overall Study	Withdrawal by Subject	48	16

Baseline characteristics

Characteristic	Group 1 rLP2086	Group 2 Saline	Total
Age, Continuous	21.47 Years STANDARD_DEVIATION 2.14	21.52 Years STANDARD_DEVIATION 2.2	21.48 Years STANDARD_DEVIATION 2.15
Sex: Female, Male Female	1452 Participants	482 Participants	1934 Participants
Sex: Female, Male Male	1019 Participants	340 Participants	1359 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2,193 / 2,471	567 / 822
serious Total, serious adverse events	33 / 2,471	11 / 822

Outcome results

Primary

Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. Here, number of participants analyzed signifies subjects that were evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Group 1 rLP2086	Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase	5.6 Days	Standard Deviation 10.75
Group 2 Saline	Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase	5.6 Days	Standard Deviation 13.26

Primary

Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination

Time frame: Within 30 minutes after first vaccination

Population: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination	0.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination	0.6 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination

Time frame: Within 30 minutes after second vaccination

Population: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination	0.4 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination

Time frame: Within 30 minutes after third vaccination

Population: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination	0.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination	0.0 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period

Time frame: From the first vaccination up to 6 month after the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period	21.89 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period	21.17 Percentage of participants

Primary

Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination

Time frame: Within 7 days after first vaccination

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Any	84.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Mild	42.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Moderate	37.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Severe	4.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Any	13.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Mild	5.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Moderate	7.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Severe	0.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Any	15.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Mild	8.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Moderate	6.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Severe	0.2 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Moderate	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Any	11.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Moderate	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Mild	10.7 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Mild	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Moderate	1.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Severe	0.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Pain at injection site: Severe	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Severe	0.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Any	0.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Swelling: Any	0.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination	Redness: Mild	0.5 Percentage of participants

Primary

Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination

Time frame: Within 7 days after second vaccination

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Any	79.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Mild	42.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Moderate	32.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Severe	4.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Any	11.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Mild	4.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Moderate	6.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Severe	0.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Any	14.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Mild	7.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Moderate	6.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Severe	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Moderate	0.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Any	7.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Moderate	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Mild	6.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Mild	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Moderate	1.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Severe	0.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Pain at injection site: Severe	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Severe	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Any	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Swelling: Any	0.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination	Redness: Mild	0.1 Percentage of participants

Primary

Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination

Time frame: Within 7 days after third vaccination

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Any	80.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Mild	36.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Moderate	38.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Severe	5.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Any	17.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Mild	6.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Moderate	8.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Severe	2.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Any	16.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Mild	8.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Moderate	7.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Severe	0.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Moderate	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Any	6.7 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Moderate	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Mild	6.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Mild	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Moderate	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Severe	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Pain at injection site: Severe	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Severe	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Any	0.2 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Swelling: Any	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination	Redness: Mild	0.2 Percentage of participants

Primary

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination

Time frame: Within 7 days after first vaccination

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Severe(N=2425, 798)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever 38 to <38.5 degreesC(N=2415, 796)	1.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever 38.5 to<39 degrees C(N=2415, 796)	0.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever 39 to 40 degrees C (N=2415, 796)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever >40 degrees C(N=2415, 796)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Any(N=2425, 798)	2.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Mild(N=2425, 798)	2.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Moderate(N=2425, 798)	0.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever >=38 degrees C(N=2415, 796)	2.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Any(N=2425, 798)	12.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Mild(N=2425, 798)	10.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Moderate(N=2425, 798)	2.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Severe(N=2425, 798)	0.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Any(N=2425, 798)	43.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Mild(N=2425, 798)	24.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Moderate(N=2425, 798)	17.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Severe(N=2425, 798)	1.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Any(N=2425, 798)	50.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Mild(N=2425, 798)	25.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Moderate(N=2425, 798)	22.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Severe(N=2425, 798)	3.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills:Any(N=2425, 798)	18.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills:Mild(N=2425, 798)	12.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills:Moderate(N=2425, 798)	4.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills: Severe(N=2425, 798)	1.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Any(N=2425,798)	25.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Mild(N=2425,798)	13.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Moderate(N=2425,798)	11.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Severe(N=2425,798)	1.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain:Any(N=2425,798)	19.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain:Mild(N=2425,798)	10.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain:Moderate(N=2425,798)	7.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain: Severe(N=2425,798)	1.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Antipyretic medication(N=2425,798)	13.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Any(N=2425,798)	14.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever >=38 degrees C(N=2415, 796)	0.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Any(N=2425, 798)	39.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever 38 to <38.5 degreesC(N=2415, 796)	0.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Antipyretic medication(N=2425,798)	8.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever 38.5 to<39 degrees C(N=2415, 796)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Mild(N=2425, 798)	23.2 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever 39 to 40 degrees C (N=2415, 796)	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Mild(N=2425,798)	9.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fever >40 degrees C(N=2415, 796)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Moderate(N=2425, 798)	15.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Any(N=2425, 798)	2.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain:Mild(N=2425,798)	6.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Mild(N=2425, 798)	2.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Fatigue:Severe(N=2425, 798)	0.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Moderate(N=2425, 798)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Moderate(N=2425,798)	4.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Vomiting:Severe(N=2425, 798)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills:Any(N=2425, 798)	9.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Any(N=2425, 798)	11.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain: Severe(N=2425,798)	0.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Mild(N=2425, 798)	9.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills:Mild(N=2425, 798)	8.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Moderate(N=2425, 798)	1.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Muscle pain:Severe(N=2425,798)	0.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Diarrhea:Severe(N=2425, 798)	0.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills:Moderate(N=2425, 798)	1.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Any(N=2425, 798)	36.2 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain:Moderate(N=2425,798)	3.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Mild(N=2425, 798)	22.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Chills: Severe(N=2425, 798)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Moderate(N=2425, 798)	13.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Joint pain:Any(N=2425,798)	10.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Headache:Severe(N=2425, 798)	0.6 Percentage of participants

Primary

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination

Time frame: Within 7 days after second vaccination

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Moderate(N=2076, 706)	1.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Any(N=2076, 706)	39.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever >=38 degrees C(N=2067, 705)	1.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever 38 to <38.5 degreesC(N=2067, 705)	0.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever 38.5 to<39 degrees C(N=2067, 705)	0.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever 39 to 40 degrees C (N=2067, 705)	0.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever >40 degrees C(N=2067, 705)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Any(N=2076, 706)	2.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Severe(N=2076, 706)	1.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Mild(N=2076, 706)	1.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Moderate(N=2076, 706)	0.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Severe(N=2076, 706)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Any(N=2076, 706)	8.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Mild(N=2076, 706)	6.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Severe(N=2076, 706)	0.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Any(N=2076, 706)	33.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Mild(N=2076, 706)	18.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Moderate(N=2076, 706)	13.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Mild(N=2076, 706)	20.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Moderate(N=2076, 706)	16.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Severe(N=2076, 706)	2.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills:Any(N=2076, 706)	12.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills:Mild(N=2076, 706)	8.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills:Moderate(N=2076, 706)	3.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills: Severe(N=2076, 706)	0.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Any(N=2076, 706)	15.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Mild(N=2076, 706)	7.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Moderate(N=2076, 706)	7.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Severe(N=2076, 706)	0.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain:Any(N=2076, 706)	15.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain:Mild(N=2076, 706)	8.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain:Moderate(N=2076, 706)	6.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain: Severe(N=2076, 706)	0.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Antipyretic medication(N=2076, 706)	12.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Any(N=2076, 706)	8.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Severe(N=2076, 706)	1.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Moderate(N=2076, 706)	10.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Any(N=2076, 706)	27.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Antipyretic medication(N=2076, 706)	7.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever >=38 degrees C(N=2067, 705)	1.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Mild(N=2076, 706)	13.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever 38 to <38.5 degreesC(N=2067, 705)	0.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Mild(N=2076, 706)	5.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever 38.5 to<39 degrees C(N=2067, 705)	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Moderate(N=2076, 706)	11.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever 39 to 40 degrees C (N=2067, 705)	0.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain:Mild(N=2076, 706)	3.7 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fever >40 degrees C(N=2067, 705)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Fatigue:Severe(N=2076, 706)	2.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Any(N=2076, 706)	1.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Moderate(N=2076, 706)	2.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills:Any(N=2076, 706)	8.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Mild(N=2076, 706)	1.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain: Severe(N=2076, 706)	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Moderate(N=2076, 706)	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills:Mild(N=2076, 706)	6.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Vomiting:Severe(N=2076, 706)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Muscle pain:Severe(N=2076, 706)	0.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Any(N=2076, 706)	8.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills:Moderate(N=2076, 706)	1.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Mild(N=2076, 706)	4.7 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Moderate(N=2076, 706)	2.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain:Moderate(N=2076, 706)	2.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Diarrhea:Severe(N=2076, 706)	0.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Chills: Severe(N=2076, 706)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Any(N=2076, 706)	24.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Joint pain:Any(N=2076, 706)	6.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Headache:Mild(N=2076, 706)	13.6 Percentage of participants

Primary

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination

Time frame: Within 7 days after third vaccination

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Severe(N=1823, 624)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever 38 to <38.5 degreesC(N=1814, 621)	1.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever 38.5 to<39 degrees C(N=1814, 621)	0.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever 39 to 40 degrees C (N=1814, 621)	0.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever >40 degrees C(N=1814, 621)	0.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Any(N=1823, 624)	2.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Mild(N=1823, 624)	1.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Moderate(N=1823, 624)	0.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever >=38 degrees C(N=1814, 621)	2.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Any(N=1823, 624)	7.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Mild(N=1823, 624)	6.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Moderate(N=1823, 624)	1.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Severe(N=1823, 624)	0.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Any(N=1823, 624)	32.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Mild(N=1823, 624)	17.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Moderate(N=1823, 624)	13.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Severe(N=1823, 624)	1.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Any(N=1823, 624)	39.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Mild(N=1823, 624)	18.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Moderate(N=1823, 624)	18.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Severe(N=1823, 624)	1.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills:Any(N=1823, 624)	12.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills:Mild(N=1823, 624)	7.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills:Moderate(N=1823, 624)	4.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills: Severe(N=1823, 624)	0.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Any(N=1823, 624)	16.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Mild(N=1823, 624)	8.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Moderate(N=1823, 624)	6.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Severe(N=1823, 624)	1.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain:Any(N=1823, 624)	12.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain:Mild(N=1823, 624)	6.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain:Moderate(N=1823, 624)	5.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain: Severe(N=1823, 624)	0.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Antipyretic medication(N=1823, 624)	12.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Any(N=1823, 624)	7.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever >=38 degrees C(N=1814, 621)	0.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Any(N=1823, 624)	24.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever 38 to <38.5 degreesC(N=1814, 621)	0.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Antipyretic medication(N=1823, 624)	6.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever 38.5 to<39 degrees C(N=1814, 621)	0.2 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Mild(N=1823, 624)	13.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever 39 to 40 degrees C (N=1814, 621)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Mild(N=1823, 624)	4.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fever >40 degrees C(N=1814, 621)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Moderate(N=1823, 624)	9.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Any(N=1823, 624)	1.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain:Mild(N=1823, 624)	2.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Mild(N=1823, 624)	1.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Fatigue:Severe(N=1823, 624)	1.8 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Moderate(N=1823, 624)	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Moderate(N=1823, 624)	2.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Vomiting:Severe(N=1823, 624)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills:Any(N=1823, 624)	6.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Any(N=1823, 624)	6.9 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain: Severe(N=1823, 624)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Mild(N=1823, 624)	5.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills:Mild(N=1823, 624)	4.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Moderate(N=1823, 624)	1.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Muscle pain:Severe(N=1823, 624)	0.2 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Diarrhea:Severe(N=1823, 624)	0.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills:Moderate(N=1823, 624)	2.1 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Any(N=1823, 624)	21.6 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain:Moderate(N=1823, 624)	2.4 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Mild(N=1823, 624)	12.5 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Chills: Severe(N=1823, 624)	0.0 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Moderate(N=1823, 624)	8.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Joint pain:Any(N=1823, 624)	5.3 Percentage of participants
Group 2 Saline	Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Headache:Severe(N=1823, 624)	0.8 Percentage of participants

Primary

Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase	31.20 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase	31.14 Percentage of participants

Primary

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination

Time frame: Within 30 days after any vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination	21.17 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination	18.86 Percentage of participants

Primary

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination	8.62 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination	7.30 Percentage of participants

Primary

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination

Time frame: Within 30 days after second vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination	10.10 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination	10.10 Percentage of participants

Primary

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination	9.26 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination	7.24 Percentage of participants

Primary

Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase

Time frame: From 1 month after third vaccination up to 6 months after the third vaccination

Population: Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase	6.97 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase	6.68 Percentage of participants

Primary

Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase	19.22 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase	17.76 Percentage of participants

Primary

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination

Time frame: Within 30 days after any vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination	10.93 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination	10.22 Percentage of participants

Primary

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination	3.89 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination	3.77 Percentage of participants

Primary

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination

Time frame: Within 30 days after second vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination	4.66 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination	4.91 Percentage of participants

Primary

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination	5.03 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination	3.85 Percentage of participants

Primary

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase

Time frame: From 1 month after third vaccination up to 6 months after the third vaccination

Population: Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase	0.10 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase	0.00 Percentage of participants

Primary

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase	0.32 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase	0.24 Percentage of participants

Primary

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period

Time frame: From the first vaccination up to 6 month after the third vaccination the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period	0.40 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period	0.24 Percentage of participants

Primary

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination

Time frame: Within 30 days after any vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination	0.20 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination	0.12 Percentage of participants

Primary

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination	0.00 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination	0.00 Percentage of participants

Primary

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination

Time frame: Within 30 days after second vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination	0.23 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination	0.00 Percentage of participants

Primary

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination	0.00 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination	0.15 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase

Time frame: From 1 month after third vaccination up to 6 months after the third vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase	0.63 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase	0.71 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase	0.85 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase	0.73 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period

Time frame: From the first vaccination up to 6 month after the third vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period	1.34 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period	1.34 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination

Time frame: Within 30 days after any vaccination

Population: Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination	0.53 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination	0.24 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination	0.24 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination	0.12 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination

Time frame: Within 30 days after second vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination	0.23 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination	0.00 Percentage of participants

Primary

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Arm	Measure	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination	0.11 Percentage of participants
Group 2 Saline	Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination	0.15 Percentage of participants

Primary

Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1

Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.

Time frame: One month after third bivalent rLP2086 vaccination

Population: Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	Composite hSBA response (N=1664)	84.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	PMB80 [A22] (N=1695)	80.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	PMB2001 [A56] (N=1642)	90.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	PMB2948 [B24] (N=1675)	79.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	PMB2707 [B44] (N=1696)	79.6 Percentage of participants

Secondary

hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1

Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3

Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB80[A22]: Before Vac 1 (N=1704)	12.8 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB80[A22]: 1 Month after Vac 2 (N=1697)	49.0 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB80[A22]: 1 Month after Vac 3 (N=1714)	74.3 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2001[A56]: Before Vac 1 (N=1657)	8.8 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2001[A56]: 1 Month after Vac 2 (N=1701)	114.3 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2001[A56]: 1 Month after Vac 3 (N=1708)	176.7 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2948[B24]: Before Vac 1 (N=1696)	7.6 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2948[B24]: 1 Month after Vac 2 (N=1685)	35.8 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2948[B24]: 1 Month after Vac 3 (N=1702)	49.5 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2707[B44]: Before Vac 1 (N=1716)	4.8 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2707[B44]: 1 Month after Vac 2 (N=1693)	22.6 Titer
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	PMB2707[B44]: 1 Month after Vac 3 (N=1703)	47.6 Titer

Secondary

hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1

Time frame: Before first vaccination, 1 month after third vaccination

Population: Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain. This outcome measure was planned to be analyzed for Group 1 only.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB3175[A29]:Before Vaccination 1 (N=280)	7.1 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB3175[A29]:1 Month after Vaccination 3 (N=283)	96.3 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB3010[A06]:Before Vaccination 1 (N=275)	10.3 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB3010[A06]:1 Month after Vaccination 3 (N=275)	69.9 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB3040[A07]:Before Vaccination 1 (N=274)	13.9 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB3040[A07]:1 Month after Vaccination 3 (N=277)	60.4 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB824[A12]: Before Vaccination 1 (N=278)	8.4 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB824[A12]:1 Month after Vaccination 3 (N=275)	20.6 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB1672[A15]:Before Vaccination 1 (N=279)	8.0 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB1672[A15]:1 Month after Vaccination 3 (N=279)	43.1 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB1989[A19]:Before Vaccination 1 (N=278)	12.1 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB1989[A19]:1 Month after Vaccination 3 (N=284)	87.3 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB1256[B03]:Before Vaccination 1 (N=277)	5.1 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB1256[B03]:1 Month after Vaccination 3 (N=273)	49.8 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB866[B09]:Before Vaccination 1 (N=277)	6.1 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB866[B09]:1 Month after Vaccination 3 (N=274)	23.3 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB431[B15]:Before Vaccination 1 (N=274)	9.1 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB431[B15]:1 Month after Vaccination 3 (N=276)	49.4 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB648[B16]:Before Vaccination 1 (N=270)	6.2 Titers
Group 1 rLP2086	hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB648[B16]:1 Month after Vaccination 3 (N=273)	26.5 Titers

Secondary

Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1

Time frame: One month after third bivalent rLP2086 vaccination

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB2948[B24]: 1 Month after Vac 3 (N=1675)	87.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB80[A22]: 1 Month after Vac 3 (N=1695)	89.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB2001[A56]: 1 Month after Vac 3 (N=1642)	95.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	PMB2707[B44]: 1 Month after Vac 3(N=1696)	81.8 Percentage of participants

Secondary

Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination

Time frame: One month after third bivalent rLP2086 vaccination

Population: Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.

Secondary

Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1

Time frame: One month after second Bivalent rLP2086 vaccination

Population: Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point. This outcome measure was planned to be analyzed for Group 1 only.

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1	PMB80[A22] (N=1679)	66.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1	PMB2001[A56] (N=1637)	85.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1	PMB2948[B24] (N=1658)	67.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1	PMB2707[B44] (N=1686)	55.5 Percentage of participants

Secondary

Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1

Time frame: Before vaccination 1, 1 Month after Vaccination 2

Population: Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point. This outcome measure was planned to be analyzed for Group 1 only.

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1	Before First Vaccination (N=1612)	7.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1	1 Month after Vaccination 2 (N=1620)	64.5 Percentage of participants

Secondary

Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1

Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary endpoint 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1'.

Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB80[A22] 1:4 (N=1704)	42.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB80[A22] 1:4 (N=1697)	86.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB80[A22] 1:4 (N=1714)	94.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB80[A22] 1:8 (N=1704)	38.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB80[A22] 1:8 (N=1697)	85.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB80[A22] 1:8 (N=1714)	94.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB80[A22] 1:32 (N=1704)	19.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB80[A22] 1:32 (N=1697)	71.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB80[A22] 1:32 (N=1714)	85.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB80[A22] 1:64 (N=1704)	9.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB80[A22] 1:64 (N=1697)	49.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB80[A22] 1:64 (N=1714)	64.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB80[A22] 1:128 (N=1704)	3.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB80[A22] 1:128 (N=1697)	29.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB80[A22] 1:128 (N=1714)	41.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2001[A56] 1:4 (N=1657)	35.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2001[A56] 1:4 (N=1701)	97.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2001[A56] 1:4 (N=1708)	99.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2001[A56] 1:16 (N=1657)	30.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2001[A56] 1:16 (N=1701)	97.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2001[A56] 1:16 (N=1708)	99.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2001[A56] ] 1:32 (N=1657)	24.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2001[A56] 1:32 (N=1701)	92.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2001[A56] 1:32 (N=1708)	97.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2001[A56] 1:64 (N=1657)	16.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2 :PMB2001[A56] 1:64 (N=1701)	80.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3 :PMB2001[A56] 1:64 (N=1708)	90.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2001[A56] 1:128 (N=1657)	7.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2001[A56] 1:128 (N=1701)	56.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2001[A56] 1:128 (N=1708)	73.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2948[B24] 1:4 (N=1696)	35.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2948[B24] 1:4 (N=1685)	87.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2948[B24] 1:4 (N=1702)	95.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2948[B24] 1:16 (N=1696)	29.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2948[B24] 1:16 (N=1685)	83.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2948[B24] 1:16 (N=1702)	93.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2948[B24] 1:32 (N=1696)	18.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2948[B24] 1:32 (N=1685)	65.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2948[B24] 1:32 (N=1702)	75.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2948[B24] 1:64 (N=1696)	8.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2948[B24] 1:64 (N=1685)	40.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2948[B24] 1:64 (N=1702)	48.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2948[B24] 1:128 (N=1696)	3.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2948[B24] 1:128 (N=1685)	22.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2948[B24] 1:128 (N=1702)	27.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2707[B44] 1:4 (N=1716)	14.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2707[B44] 1:4 (N=1693)	71.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2707[B44] 1:4 (N=1703)	89.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2707[B44] 1:16 (N=1716)	7.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2707[B44] 1:16 (N=1693)	61.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2707[B44] 1:16 (N=1703)	83.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2707[B44] 1:32 (N=1716)	4.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2707[B44] 1:32 (N=1693)	41.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2707[B44] 1:32 (N=1703)	67.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2707[B44] 1:64 (N=1716)	2.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2707[B44] 1:64 (N=1693)	30.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2707[B44] 1:64 (N=1703)	49.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2707[B44] 1:128 (N=1716)	0.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2707[B44] 1:128 (N=1693)	21.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2707[B44] 1:128 (N=1703)	32.1 Percentage of participants

Secondary

Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1

Time frame: Before first vaccination, 1 month after third vaccination (Vac)

Population: Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3175[A29] 1:4 (N=280)	32.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3175[A29] 1:4 (N=283)	99.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3175[A29] 1:8 (N=280)	31.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3175[A29] 1:8 (N=283)	99.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3175[A29] 1:16 (N=280)	27.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3175[A29] 1:16 (N=283)	98.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3175[A29] 1:32 (N=280)	16.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3175[A29] 1:32 (N=283)	96.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3175[A29] 1:64 (N=280)	5.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3175[A29] 1:64 (N=283)	80.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3175[A29] 1:128 (N=280)	2.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3175[A29] 1:128 (N=283)	53.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3010[A06] 1:4 (N=275)	18.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3010[A06] 1:4 (N=275)	92.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3010[A06] 1:8 (N=275)	17.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3010[A06] 1:8 (N=275)	92.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3010[A06] 1:16 (N=275)	16.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3010[A06] 1:16 (N=275)	92.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3010[A06] 1:32 (N=275)	10.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3010 [A06] 1:32 (N=275)	86.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3010[A06] 1:64 (N=275)	6.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3010[A06] 1:64 (N=275)	70.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3010[A06] 1:128 (N=275)	2.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3010[A06] 1:128 (N=275)	41.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3040[A07] 1:4 (N=274)	55.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3040[A07] 1:4 (N=277)	95.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3040[A07] 1:8 (N=274)	55.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3040[A07] 1:8 (N=277)	95.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3040[A07] 1:16 (N=274)	55.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3040[A07] 1:16 (N=277)	95.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3040[A07] 1:32 (N=274)	42.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3040[A07] 1:32 (N=277)	92.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3040[A07] 1:64 (N=274)	21.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3040[A07] 1:64 (N=277)	72.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB3040[A07] 1:128 (N=274)	4.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB3040[A07] 1:128 (N=277)	29.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB824[A12] 1:4 (N=278)	10.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB824[A12] 1:4 (N=275)	73.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB824[A12] 1:8 (N=278)	8.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB824[A12] 1:8 (N=275)	73.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB824[A12] 1:16 (N=278)	5.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB824[A12] 1:16 (N=275)	71.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB824[A12] 1:32 (N=278)	2.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB824[A12] 1:32 (N=275)	46.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB824[A12] 1:64 (N=278)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB824[A12] 1:64 (N=275)	15.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB824[A12] 1:128 (N=278)	0.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB824[A12] 1:128 (N=275)	3.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1672[A15] 1:4 (N=279)	39.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1672[A15] 1:4 (N=279)	91.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1672[A15] 1:8 (N=279)	37.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1672[A15] 1:8 (N=279)	91.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1672[A15] 1:16 (N=279)	33.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1672[A15] 1:16 (N=279)	91.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1672[A15] 1:32 (N=279)	20.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1672[A15] 1:32 (N=279)	82.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1672[A15] 1:64 (N=279)	7.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1672[A15] 1:64 (N=279)	54.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1672[A15] 1:128 (N=279)	1.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1672[A15] 1:128 (N=279)	19.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1989[A19] 1:4 (N=278)	39.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1989[A19] 1:4 (N=284)	96.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1989[A19] 1:8 (N=278)	37.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1989[A19] 1:8 (N=284)	96.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1989[A19] 1:16 (N=278)	28.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1989[A19] 1:16 (N=284)	95.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1989[A19] 1:32 (N=278)	18.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1989[A19] 1:32 (N=284)	92.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1989[A19] 1:64 (N=278)	9.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1989[A19] 1:64 (N=284)	77.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1989[A19] 1:128 (N=278)	9.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1989[A19] 1:128 (N=284)	49.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1256[B03] 1:4 (N=277)	13.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1256[B03] 1:4 (N=273)	86.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1256[B03] 1:8 (N=277)	11.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1256[B03] 1:8 (N=273)	86.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1256[B03] 1:16 (N=277)	10.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1256[B03] 1:16 (N=273)	85.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1256[B03] 1:32 (N=277)	7.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1256[B03] 1:32 (N=273)	78.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1256[B03] 1:64 (N=277)	4.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1256[B03] 1:64 (N=273)	56.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB1256[B03] 1:128 (N=277)	1.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB1256[B03] 1:128 (N=273)	30.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB866[B09] 1:4 (N=277)	24.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB866[B09] 1:4 (N=274)	78.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB866[B09] 1:8 (N=277)	23.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB866[B09] 1:8 (N=274)	77.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB866[B09] 1:16 (N=277)	18.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB866[B09] 1:16 (N=274)	73.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB866[B09] 1:32 (N=277)	11.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB866[B09] 1:32 (N=274)	52.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB866[B09] 1:64 (N=277)	4.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB866[B09] 1:64 (N=274)	27.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB866[B09] 1:128 (N=277)	1.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB866[B09] 1:128 (N=274)	12.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB431[B15] 1:4 (N=274)	44.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB431[B15] 1:4 (N=276)	97.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB431[B15] 1:8 (N=274)	43.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB431[B15] 1:8 (N=276)	96.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB431[B15] 1:16 (N=274)	41.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB431[B15] 1:16 (N=276)	96.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB431[B15] 1:32 (N=274)	23.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB431[B15] 1:32 (N=276)	84.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB431[B15] 1:64 (N=274)	8.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB431[B15] 1:64 (N=276)	56.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB431[B15] 1:128 (N=274)	1.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB431[B15] 1:128 (N=276)	22.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB648[B16] 1:4 (N=270)	24.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB648[B16] 1:4 (N=273)	79.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB648[B16] 1:8 (N=270)	21.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB648[B16] 1:8 (N=273)	78.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB648[B16] 1:16 (N=270)	18.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB648[B16] 1:16 (N=273)	76.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB648[B16] 1:32 (N=270)	11.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB648[B16] 1:32 (N=273)	61.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB648[B16] 1:64 (N=270)	7.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB648[B16] 1:64 (N=273)	34.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	Before Vaccination 1: PMB648[B16] 1:128 (N=270)	1.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB648[B16] 1:128 (N=273)	16.8 Percentage of participants

Secondary

Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1

Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB80[A22] 1:16 (N=1704)	33.6 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB80[A22] 1:16 (N=1697)	84.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB80[A22] 1:16 (N=1714)	93.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2001[A56] 1:8 (N=1657)	32.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2001[A56] 1:8) (N=1701)	97.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2001[A56] 1:8 (N=1708)	99.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2948[B24] 1:8 (N=1696)	33.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2948[B24] 1:8 (N=1685)	86.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3:PMB2948[B24] 1:8 (N=1702)	95.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Before Vac 1: PMB2707[B44] 1:8 (N=1716)	11.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 2: PMB2707[B44] 1:8 (N=1693)	68.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	1 month after Vac 3: PMB2707[B44] 1:8 (N=1703)	87.4 Percentage of participants

Secondary

Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1

Time frame: Before first vaccination, 1 month after third vaccination

Population: Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.

Arm	Measure	Group	Value (NUMBER)
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB3175[A29]:Before Vaccination 1 (N=280)	31.1 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB3175[A29]:1 Month after Vaccination 3 (N=283)	99.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB3010[A06]:Before Vaccination 1 (N=275)	16.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB3010[A06]:1 Month after Vaccination 3 (N=275)	92.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB3040[A07]:Before Vaccination 1 (N=274)	55.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB3040[A07]:1 Month after Vaccination 3 (N=277)	95.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB824[A12]: Before Vaccination 1 (N=278)	5.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB824[A12]:1 Month after Vaccination 3 (N=275)	71.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB1672[A15]:Before Vaccination 1 (N=279)	37.3 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB1672[A15]:1 Month after Vaccination 3 (N=279)	91.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB1989[A19]:Before Vaccination 1 (N=278)	28.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB1989[A19]:1 Month after Vaccination 3 (N=284)	95.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB1256[B03]:Before Vaccination 1 (N=277)	11.2 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB1256[B03]:1 Month after Vaccination 3 (N=273)	86.4 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB866[B09]:Before Vaccination 1 (N=277)	23.5 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB866[B09]:1 Month after Vaccination 3 (N=274)	77.0 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB431[B15]:Before Vaccination 1 (N=274)	43.8 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB431[B15]:1 Month after Vaccination 3 (N=276)	96.7 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB648[B16]:Before Vaccination 1 (N=270)	21.9 Percentage of participants
Group 1 rLP2086	Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1	PMB648[B16]:1 Month after Vaccination 3 (N=273)	78.0 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026

A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase

Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination

Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination

Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination

Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period

Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination

Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination

Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination

Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination

Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase

Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination

Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1

hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1

hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1

Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1

Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination

Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1

Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1

Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1

Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1

Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1

Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1