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CompletedNCT01352845B1971016Updated Feb 23, 2016Results posted

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 interventional study of rLP2086 and Placebo in Healthy, sponsored by Pfizer. Completed at 58 sites in 6 countries. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-23.

Sponsored by Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
3,301
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3,301 participants (actual)

Study arms

  • Experimental
    rLP2086

    Biological: rLP2086

  • Placebo comparator
    Control

    Steril normal saline solution

    Other: Placebo

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

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: Within 7 days after first vaccination

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

    Time frame: Within 7 days after second vaccination

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

    Time frame: Within 7 days after third vaccination

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

    Time frame: Within 7 days after first vaccination

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

    Time frame: Within 7 days after second vaccination

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

    Time frame: Within 7 days after third vaccination

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

    Time frame: Within 30 days after first vaccination

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

    Time frame: Within 30 days after second vaccination

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

    Time frame: Within 30 days after third vaccination

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

    Time frame: Within 30 days after any vaccination

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

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

    Time frame: Within 30 days after first vaccination

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

    Time frame: Within 30 days after second vaccination

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

    Time frame: Within 30 days after third vaccination

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

    Time frame: Within 30 days after any vaccination

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

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

    Time frame: Within 30 minutes after first vaccination

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

    Time frame: Within 30 minutes after second vaccination

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

    Time frame: Within 30 minutes after third vaccination

  37. 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

Secondary outcomes

  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

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

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

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

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

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

  4. 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

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

    Time frame: One month after second Bivalent rLP2086 vaccination

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

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

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

    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

  8. 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

  9. 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

  10. 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

07

Results

Posted Feb 23, 2016

Participant flow

Participant flow — Overall Study
MilestoneGroup 1 rLP2086Group 2 Saline
Started2471822
Completed1800619
Not completed671203
Withdrew: Lost to follow-up31392
Withdrew: No longer willing to participate20558
Withdrew: Withdrawal by subject4816
Withdrew: No longer meets eligibility criteria2411
Withdrew: Pregnancy277
Withdrew: Adverse event226
Withdrew: Other177
Withdrew: Protocol violation126
Withdrew: Death30

Outcome measures

PrimaryPercentage 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
Reported as:
Number · Percentage of participants
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
Percentage of participantsGroup 1 rLP2086
Composite hSBA response (N=1664)84.9 (83.1 to 86.6)
PMB80 [A22] (N=1695)80.5 (78.6 to 82.4)
PMB2001 [A56] (N=1642)90.0 (88.4 to 91.4)
PMB2948 [B24] (N=1675)79.3 (77.3 to 81.2)
PMB2707 [B44] (N=1696)79.6 (77.6 to 81.5)
PrimaryPercentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Time frame:
Within 7 days after first vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Pain at injection site: Any84.2 (82.7 to 85.6)11.8 (9.6 to 14.2)
Pain at injection site: Mild42.3 (40.3 to 44.3)10.7 (8.6 to 13.0)
Pain at injection site: Moderate37.1 (35.1 to 39.0)1.1 (0.5 to 2.1)
Pain at injection site: Severe4.8 (4.0 to 5.8)0.0 (0.0 to 0.5)
Redness: Any13.8 (12.5 to 15.3)0.6 (0.2 to 1.5)
Redness: Mild5.8 (4.9 to 6.8)0.5 (0.1 to 1.3)
Redness: Moderate7.1 (6.1 to 8.2)0.0 (0.0 to 0.5)
Redness: Severe0.9 (0.6 to 1.4)0.1 (0.0 to 0.7)
Swelling: Any15.5 (14.1 to 17.1)0.6 (0.2 to 1.5)
Swelling: Mild8.5 (7.4 to 9.7)0.3 (0.0 to 0.9)
Swelling: Moderate6.8 (5.8 to 7.9)0.3 (0.0 to 0.9)
Swelling: Severe0.2 (0.1 to 0.5)0.1 (0.0 to 0.7)
PrimaryPercentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Time frame:
Within 7 days after second vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Pain at injection site: Any79.3 (77.5 to 81.1)7.8 (5.9 to 10.0)
Pain at injection site: Mild42.2 (40.1 to 44.4)6.8 (5.1 to 8.9)
Pain at injection site: Moderate32.7 (30.7 to 34.8)1.0 (0.4 to 2.0)
Pain at injection site: Severe4.4 (3.6 to 5.4)0.0 (0.0 to 0.5)
Redness: Any11.8 (10.4 to 13.3)0.3 (0.0 to 1.0)
Redness: Mild4.6 (3.7 to 5.6)0.1 (0.0 to 0.8)
Redness: Moderate6.3 (5.3 to 7.4)0.0 (0.0 to 0.5)
Redness: Severe0.9 (0.6 to 1.4)0.1 (0.0 to 0.8)
Swelling: Any14.0 (12.6 to 15.6)0.4 (0.1 to 1.2)
Swelling: Mild7.7 (6.6 to 8.9)0.3 (0.0 to 1.0)
Swelling: Moderate6.0 (5.0 to 7.1)0.1 (0.0 to 0.8)
Swelling: Severe0.3 (0.1 to 0.7)0.0 (0.0 to 0.5)
PrimaryPercentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Time frame:
Within 7 days after third vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Pain at injection site: Any80.4 (78.5 to 82.2)6.7 (4.9 to 9.0)
Pain at injection site: Mild36.1 (33.9 to 38.4)6.4 (4.6 to 8.6)
Pain at injection site: Moderate38.9 (36.6 to 41.2)0.3 (0.0 to 1.2)
Pain at injection site: Severe5.3 (4.3 to 6.5)0.0 (0.0 to 0.6)
Redness: Any17.1 (15.4 to 18.9)0.2 (0.0 to 0.9)
Redness: Mild6.2 (5.1 to 7.4)0.2 (0.0 to 0.9)
Redness: Moderate8.6 (7.3 to 9.9)0.0 (0.0 to 0.6)
Redness: Severe2.3 (1.7 to 3.1)0.0 (0.0 to 0.6)
Swelling: Any16.6 (14.9 to 18.4)0.3 (0.0 to 1.2)
Swelling: Mild8.8 (7.6 to 10.2)0.0 (0.0 to 0.6)
Swelling: Moderate7.2 (6.1 to 8.5)0.3 (0.0 to 1.2)
Swelling: Severe0.5 (0.2 to 0.9)0.0 (0.0 to 0.6)
PrimaryPercentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Time frame:
Within 7 days after first vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Fever >=38 degrees C(N=2415, 796)2.4 (1.8 to 3.0)0.6 (0.2 to 1.5)
Fever 38 to <38.5 degreesC(N=2415, 796)1.6 (1.1 to 2.2)0.4 (0.1 to 1.1)
Fever 38.5 to<39 degrees C(N=2415, 796)0.7 (0.4 to 1.2)0.0 (0.0 to 0.5)
Fever 39 to 40 degrees C (N=2415, 796)0.0 (0.0 to 0.2)0.3 (0.0 to 0.9)
Fever >40 degrees C(N=2415, 796)0.0 (0.0 to 0.2)0.0 (0.0 to 0.5)
Vomiting:Any(N=2425, 798)2.6 (2.0 to 3.3)2.1 (1.2 to 3.4)
Vomiting:Mild(N=2425, 798)2.2 (1.6 to 2.8)2.1 (1.2 to 3.4)
Vomiting:Moderate(N=2425, 798)0.4 (0.2 to 0.8)0.0 (0.0 to 0.5)
Vomiting:Severe(N=2425, 798)0.0 (0.0 to 0.2)0.0 (0.0 to 0.5)
Diarrhea:Any(N=2425, 798)12.7 (11.4 to 14.1)11.8 (9.6 to 14.2)
Diarrhea:Mild(N=2425, 798)10.2 (9.0 to 11.5)9.8 (7.8 to 12.0)
Diarrhea:Moderate(N=2425, 798)2.4 (1.8 to 3.0)1.9 (1.1 to 3.1)
Diarrhea:Severe(N=2425, 798)0.2 (0.1 to 0.5)0.1 (0.0 to 0.7)
Headache:Any(N=2425, 798)43.9 (41.9 to 45.9)36.2 (32.9 to 39.7)
Headache:Mild(N=2425, 798)24.3 (22.6 to 26.1)22.1 (19.2 to 25.1)
Headache:Moderate(N=2425, 798)17.9 (16.4 to 19.5)13.5 (11.2 to 16.1)
Headache:Severe(N=2425, 798)1.6 (1.2 to 2.2)0.6 (0.2 to 1.5)
Fatigue:Any(N=2425, 798)50.9 (48.9 to 52.9)39.8 (36.4 to 43.3)
Fatigue:Mild(N=2425, 798)25.4 (23.7 to 27.2)23.2 (20.3 to 26.3)
Fatigue:Moderate(N=2425, 798)22.1 (20.5 to 23.8)15.8 (13.3 to 18.5)
Fatigue:Severe(N=2425, 798)3.4 (2.7 to 4.2)0.9 (0.4 to 1.8)
Chills:Any(N=2425, 798)18.1 (16.5 to 19.7)9.8 (7.8 to 12.0)
Chills:Mild(N=2425, 798)12.0 (10.8 to 13.4)8.1 (6.3 to 10.3)
Chills:Moderate(N=2425, 798)4.9 (4.1 to 5.8)1.6 (0.9 to 2.8)
Chills: Severe(N=2425, 798)1.1 (0.7 to 1.6)0.0 (0.0 to 0.5)
Muscle pain:Any(N=2425,798)25.9 (24.1 to 27.6)14.5 (12.2 to 17.2)
Muscle pain:Mild(N=2425,798)13.0 (11.7 to 14.4)9.6 (7.7 to 11.9)
Muscle pain:Moderate(N=2425,798)11.3 (10.0 to 12.6)4.4 (3.1 to 6.0)
Muscle pain:Severe(N=2425,798)1.6 (1.1 to 2.2)0.5 (0.1 to 1.3)
Joint pain:Any(N=2425,798)19.6 (18.1 to 21.3)10.9 (8.8 to 13.3)
Joint pain:Mild(N=2425,798)10.3 (9.1 to 11.6)6.9 (5.2 to 8.9)
Joint pain:Moderate(N=2425,798)7.9 (6.8 to 9.0)3.5 (2.3 to 5.0)
Joint pain: Severe(N=2425,798)1.4 (1.0 to 2.0)0.5 (0.1 to 1.3)
Antipyretic medication(N=2425,798)13.4 (12.1 to 14.8)8.9 (7.0 to 11.1)
PrimaryPercentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Time frame:
Within 7 days after second vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Fever >=38 degrees C(N=2067, 705)1.2 (0.7 to 1.7)1.0 (0.4 to 2.0)
Fever 38 to <38.5 degreesC(N=2067, 705)0.7 (0.4 to 1.1)0.6 (0.2 to 1.4)
Fever 38.5 to<39 degrees C(N=2067, 705)0.4 (0.2 to 0.8)0.3 (0.0 to 1.0)
Fever 39 to 40 degrees C (N=2067, 705)0.1 (0.0 to 0.3)0.1 (0.0 to 0.8)
Fever >40 degrees C(N=2067, 705)0.0 (0.0 to 0.2)0.0 (0.0 to 0.5)
Vomiting:Any(N=2076, 706)2.1 (1.5 to 2.8)1.6 (0.8 to 2.8)
Vomiting:Mild(N=2076, 706)1.6 (1.1 to 2.3)1.3 (0.6 to 2.4)
Vomiting:Moderate(N=2076, 706)0.5 (0.2 to 0.9)0.3 (0.0 to 1.0)
Vomiting:Severe(N=2076, 706)0.0 (0.0 to 0.2)0.0 (0.0 to 0.5)
Diarrhea:Any(N=2076, 706)8.6 (7.4 to 9.9)8.1 (6.2 to 10.3)
Diarrhea:Mild(N=2076, 706)6.4 (5.3 to 7.5)4.7 (3.2 to 6.5)
Diarrhea:Moderate(N=2076, 706)1.7 (1.2 to 2.4)2.8 (1.7 to 4.3)
Diarrhea:Severe(N=2076, 706)0.5 (0.3 to 0.9)0.6 (0.2 to 1.4)
Headache:Any(N=2076, 706)33.1 (31.1 to 35.2)24.9 (21.8 to 28.3)
Headache:Mild(N=2076, 706)18.4 (16.8 to 20.1)13.6 (11.2 to 16.3)
Headache:Moderate(N=2076, 706)13.3 (11.9 to 14.8)10.1 (7.9 to 12.5)
Headache:Severe(N=2076, 706)1.4 (1.0 to 2.1)1.3 (0.6 to 2.4)
Fatigue:Any(N=2076, 706)39.2 (37.1 to 41.3)27.3 (24.1 to 30.8)
Fatigue:Mild(N=2076, 706)20.6 (18.8 to 22.4)13.9 (11.4 to 16.7)
Fatigue:Moderate(N=2076, 706)16.4 (14.8 to 18.0)11.5 (9.2 to 14.1)
Fatigue:Severe(N=2076, 706)2.2 (1.6 to 2.9)2.0 (1.1 to 3.3)
Chills:Any(N=2076, 706)12.4 (11.0 to 13.9)8.5 (6.5 to 10.8)
Chills:Mild(N=2076, 706)8.1 (7.0 to 9.4)6.9 (5.2 to 9.1)
Chills:Moderate(N=2076, 706)3.5 (2.8 to 4.4)1.6 (0.8 to 2.8)
Chills: Severe(N=2076, 706)0.8 (0.4 to 1.2)0.0 (0.0 to 0.5)
Muscle pain:Any(N=2076, 706)15.6 (14.0 to 17.2)8.5 (6.5 to 10.8)
Muscle pain:Mild(N=2076, 706)7.6 (6.5 to 8.8)5.8 (4.2 to 7.8)
Muscle pain:Moderate(N=2076, 706)7.1 (6.1 to 8.3)2.3 (1.3 to 3.7)
Muscle pain:Severe(N=2076, 706)0.8 (0.5 to 1.3)0.4 (0.1 to 1.2)
Joint pain:Any(N=2076, 706)15.1 (13.6 to 16.7)6.5 (4.8 to 8.6)
Joint pain:Mild(N=2076, 706)8.1 (7.0 to 9.3)3.7 (2.4 to 5.3)
Joint pain:Moderate(N=2076, 706)6.2 (5.2 to 7.3)2.5 (1.5 to 4.0)
Joint pain: Severe(N=2076, 706)0.9 (0.5 to 1.4)0.3 (0.0 to 1.0)
Antipyretic medication(N=2076, 706)12.3 (10.9 to 13.8)7.6 (5.8 to 9.9)
PrimaryPercentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Time frame:
Within 7 days after third vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Fever >=38 degrees C(N=1814, 621)2.0 (1.4 to 2.7)0.6 (0.2 to 1.6)
Fever 38 to <38.5 degreesC(N=1814, 621)1.4 (0.9 to 2.0)0.5 (0.1 to 1.4)
Fever 38.5 to<39 degrees C(N=1814, 621)0.4 (0.2 to 0.9)0.2 (0.0 to 0.9)
Fever 39 to 40 degrees C (N=1814, 621)0.1 (0.0 to 0.4)0.0 (0.0 to 0.6)
Fever >40 degrees C(N=1814, 621)0.1 (0.0 to 0.3)0.0 (0.0 to 0.6)
Vomiting:Any(N=1823, 624)2.0 (1.4 to 2.7)1.4 (0.7 to 2.7)
Vomiting:Mild(N=1823, 624)1.8 (1.2 to 2.5)1.1 (0.5 to 2.3)
Vomiting:Moderate(N=1823, 624)0.2 (0.1 to 0.6)0.3 (0.0 to 1.2)
Vomiting:Severe(N=1823, 624)0.0 (0.0 to 0.2)0.0 (0.0 to 0.6)
Diarrhea:Any(N=1823, 624)7.5 (6.3 to 8.8)6.9 (5.0 to 9.2)
Diarrhea:Mild(N=1823, 624)6.1 (5.0 to 7.3)5.3 (3.7 to 7.3)
Diarrhea:Moderate(N=1823, 624)1.2 (0.8 to 1.8)1.3 (0.6 to 2.5)
Diarrhea:Severe(N=1823, 624)0.2 (0.0 to 0.5)0.3 (0.0 to 1.2)
Headache:Any(N=1823, 624)32.5 (30.4 to 34.7)21.6 (18.5 to 25.1)
Headache:Mild(N=1823, 624)17.6 (15.9 to 19.4)12.5 (10.0 to 15.4)
Headache:Moderate(N=1823, 624)13.3 (11.8 to 15.0)8.3 (6.3 to 10.8)
Headache:Severe(N=1823, 624)1.6 (1.1 to 2.3)0.8 (0.3 to 1.9)
Fatigue:Any(N=1823, 624)39.3 (37.1 to 41.6)24.5 (21.2 to 28.1)
Fatigue:Mild(N=1823, 624)18.9 (17.2 to 20.8)13.1 (10.6 to 16.0)
Fatigue:Moderate(N=1823, 624)18.8 (17.0 to 20.6)9.6 (7.4 to 12.2)
Fatigue:Severe(N=1823, 624)1.6 (1.1 to 2.3)1.8 (0.9 to 3.1)
Chills:Any(N=1823, 624)12.6 (11.1 to 14.2)6.4 (4.6 to 8.6)
Chills:Mild(N=1823, 624)7.7 (6.5 to 9.0)4.3 (2.9 to 6.2)
Chills:Moderate(N=1823, 624)4.2 (3.3 to 5.2)2.1 (1.1 to 3.5)
Chills: Severe(N=1823, 624)0.8 (0.4 to 1.3)0.0 (0.0 to 0.6)
Muscle pain:Any(N=1823, 624)16.9 (15.2 to 18.7)7.5 (5.6 to 9.9)
Muscle pain:Mild(N=1823, 624)8.9 (7.7 to 10.3)4.5 (3.0 to 6.4)
Muscle pain:Moderate(N=1823, 624)6.8 (5.7 to 8.1)2.9 (1.7 to 4.5)
Muscle pain:Severe(N=1823, 624)1.2 (0.7 to 1.8)0.2 (0.0 to 0.9)
Joint pain:Any(N=1823, 624)12.6 (11.1 to 14.2)5.3 (3.7 to 7.3)
Joint pain:Mild(N=1823, 624)6.6 (5.5 to 7.9)2.9 (1.7 to 4.5)
Joint pain:Moderate(N=1823, 624)5.4 (4.4 to 6.5)2.4 (1.4 to 3.9)
Joint pain: Severe(N=1823, 624)0.6 (0.3 to 1.1)0.0 (0.0 to 0.6)
Antipyretic medication(N=1823, 624)12.8 (11.3 to 14.5)6.6 (4.8 to 8.8)
PrimaryPercentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination
Time frame:
Within 30 days after first vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination8.62 (7.5 to 9.8)7.30 (5.6 to 9.3)
PrimaryPercentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
Time frame:
Within 30 days after second vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination10.10 (8.9 to 11.4)10.10 (8.0 to 12.5)
PrimaryPercentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
Time frame:
Within 30 days after third vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination9.26 (8.0 to 10.7)7.24 (5.4 to 9.5)
PrimaryPercentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
Time frame:
Within 30 days after any vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination21.17 (19.6 to 22.8)18.86 (16.2 to 21.7)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase31.20 (29.4 to 33.1)31.14 (28.0 to 34.4)
PrimaryPercentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
Time frame:
Within 30 days after first vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination0.24 (0.1 to 0.5)0.12 (0.0 to 0.7)
PrimaryPercentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
Time frame:
Within 30 days after second vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination0.23 (0.1 to 0.5)0.00 (0.0 to 0.5)
PrimaryPercentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
Time frame:
Within 30 days after third vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination0.11 (0.0 to 0.4)0.15 (0.0 to 0.9)
PrimaryPercentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
Time frame:
Within 30 days after any vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination0.53 (0.3 to 0.9)0.24 (0.0 to 0.9)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase0.63 (0.3 to 1.1)0.71 (0.2 to 1.6)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase0.85 (0.5 to 1.3)0.73 (0.3 to 1.6)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period1.34 (0.9 to 1.9)1.34 (0.7 to 2.4)
PrimaryPercentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
Time frame:
Within 30 days after first vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination3.89 (3.2 to 4.7)3.77 (2.6 to 5.3)
PrimaryPercentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
Time frame:
Within 30 days after second vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination4.66 (3.8 to 5.6)4.91 (3.5 to 6.7)
PrimaryPercentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
Time frame:
Within 30 days after third vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination5.03 (4.1 to 6.1)3.85 (2.5 to 5.6)
PrimaryPercentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
Time frame:
Within 30 days after any vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination10.93 (9.7 to 12.2)10.22 (8.2 to 12.5)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase19.22 (17.7 to 20.8)17.76 (15.2 to 20.5)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase6.97 (5.9 to 8.2)6.68 (4.9 to 8.8)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period21.89 (20.3 to 23.6)21.17 (18.4 to 24.1)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination0.00 (0.0 to 0.1)0.00 (0.0 to 0.4)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination0.23 (0.1 to 0.5)0.00 (0.0 to 0.5)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination0.00 (0.0 to 0.2)0.15 (0.0 to 0.9)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination0.20 (0.1 to 0.5)0.12 (0.0 to 0.7)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase0.32 (0.1 to 0.6)0.24 (0.0 to 0.9)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase0.10 (0.0 to 0.3)0.00 (0.0 to 0.5)
PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period0.40 (0.2 to 0.7)0.24 (0.0 to 0.9)
PrimaryPercentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination
Time frame:
Within 30 minutes after first vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination0.4 (0.2 to 0.7)0.6 (0.2 to 1.4)
PrimaryPercentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination
Time frame:
Within 30 minutes after second vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination0.0 (0.0 to 0.3)0.4 (0.1 to 1.2)
PrimaryPercentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination
Time frame:
Within 30 minutes after third vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination
Percentage of participantsGroup 1 rLP2086Group 2 Saline
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination0.1 (0.0 to 0.3)0.0 (0.0 to 0.6)
PrimaryNumber 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
Reported as:
Mean · Days
Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase
DaysGroup 1 rLP2086Group 2 Saline
Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase5.6 ± 10.755.6 ± 13.26
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
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
Percentage of participantsGroup 1 rLP2086
PMB3175[A29]:Before Vaccination 1 (N=280)31.1 (25.7 to 36.9)
PMB3175[A29]:1 Month after Vaccination 3 (N=283)99.3 (97.5 to 99.9)
PMB3010[A06]:Before Vaccination 1 (N=275)16.0 (11.9 to 20.9)
PMB3010[A06]:1 Month after Vaccination 3 (N=275)92.0 (88.1 to 94.9)
PMB3040[A07]:Before Vaccination 1 (N=274)55.8 (49.7 to 61.8)
PMB3040[A07]:1 Month after Vaccination 3 (N=277)95.7 (92.6 to 97.7)
PMB824[A12]: Before Vaccination 1 (N=278)5.0 (2.8 to 8.3)
PMB824[A12]:1 Month after Vaccination 3 (N=275)71.3 (65.5 to 76.5)
PMB1672[A15]:Before Vaccination 1 (N=279)37.3 (31.6 to 43.2)
PMB1672[A15]:1 Month after Vaccination 3 (N=279)91.8 (87.9 to 94.7)
PMB1989[A19]:Before Vaccination 1 (N=278)28.8 (23.5 to 34.5)
PMB1989[A19]:1 Month after Vaccination 3 (N=284)95.8 (92.7 to 97.8)
PMB1256[B03]:Before Vaccination 1 (N=277)11.2 (7.7 to 15.5)
PMB1256[B03]:1 Month after Vaccination 3 (N=273)86.4 (81.8 to 90.3)
PMB866[B09]:Before Vaccination 1 (N=277)23.5 (18.6 to 28.9)
PMB866[B09]:1 Month after Vaccination 3 (N=274)77.0 (71.6 to 81.9)
PMB431[B15]:Before Vaccination 1 (N=274)43.8 (37.8 to 49.9)
PMB431[B15]:1 Month after Vaccination 3 (N=276)96.7 (93.9 to 98.5)
PMB648[B16]:Before Vaccination 1 (N=270)21.9 (17.1 to 27.3)
PMB648[B16]:1 Month after Vaccination 3 (N=273)78.0 (72.6 to 82.8)
SecondaryPercentage of 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)
Reported as:
Number · Percentage of participants
Percentage of 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 participantsGroup 1 rLP2086
Before Vaccination 1: PMB3175[A29] 1:4 (N=280)32.9 (27.4 to 38.7)
1 month after Vac 3: PMB3175[A29] 1:4 (N=283)99.3 (97.5 to 99.9)
Before Vaccination 1: PMB3175[A29] 1:8 (N=280)31.1 (25.7 to 36.9)
1 month after Vac 3: PMB3175[A29] 1:8 (N=283)99.3 (97.5 to 99.9)
Before Vaccination 1: PMB3175[A29] 1:16 (N=280)27.9 (22.7 to 33.5)
1 month after Vac 3: PMB3175[A29] 1:16 (N=283)98.9 (96.9 to 99.8)
Before Vaccination 1: PMB3175[A29] 1:32 (N=280)16.1 (12.0 to 20.9)
1 month after Vac 3: PMB3175[A29] 1:32 (N=283)96.8 (94.0 to 98.5)
Before Vaccination 1: PMB3175[A29] 1:64 (N=280)5.7 (3.3 to 9.1)
1 month after Vac 3: PMB3175[A29] 1:64 (N=283)80.9 (75.8 to 85.3)
Before Vaccination 1: PMB3175[A29] 1:128 (N=280)2.1 (0.8 to 4.6)
1 month after Vac 3: PMB3175[A29] 1:128 (N=283)53.0 (47.0 to 58.9)
Before Vaccination 1: PMB3010[A06] 1:4 (N=275)18.9 (14.5 to 24.0)
1 month after Vac 3: PMB3010[A06] 1:4 (N=275)92.4 (88.6 to 95.2)
Before Vaccination 1: PMB3010[A06] 1:8 (N=275)17.5 (13.2 to 22.5)
1 month after Vac 3: PMB3010[A06] 1:8 (N=275)92.4 (88.6 to 95.2)
Before Vaccination 1: PMB3010[A06] 1:16 (N=275)16.0 (11.9 to 20.9)
1 month after Vac 3: PMB3010[A06] 1:16 (N=275)92.0 (88.1 to 94.9)
Before Vaccination 1: PMB3010[A06] 1:32 (N=275)10.5 (7.2 to 14.8)
1 month after Vac 3: PMB3010 [A06] 1:32 (N=275)86.2 (81.5 to 90.0)
Before Vaccination 1: PMB3010[A06] 1:64 (N=275)6.5 (3.9 to 10.1)
1 month after Vac 3: PMB3010[A06] 1:64 (N=275)70.5 (64.8 to 75.9)
Before Vaccination 1: PMB3010[A06] 1:128 (N=275)2.5 (1.0 to 5.2)
1 month after Vac 3: PMB3010[A06] 1:128 (N=275)41.8 (35.9 to 47.9)
Before Vaccination 1: PMB3040[A07] 1:4 (N=274)55.8 (49.7 to 61.8)
1 month after Vac 3: PMB3040[A07] 1:4 (N=277)95.7 (92.6 to 97.7)
Before Vaccination 1: PMB3040[A07] 1:8 (N=274)55.8 (49.7 to 61.8)
1 month after Vac 3: PMB3040[A07] 1:8 (N=277)95.7 (92.6 to 97.7)
Before Vaccination 1: PMB3040[A07] 1:16 (N=274)55.5 (49.4 to 61.5)
1 month after Vac 3: PMB3040[A07] 1:16 (N=277)95.7 (92.6 to 97.7)
Before Vaccination 1: PMB3040[A07] 1:32 (N=274)42.7 (36.8 to 48.8)
1 month after Vac 3: PMB3040[A07] 1:32 (N=277)92.4 (88.6 to 95.2)
Before Vaccination 1: PMB3040[A07] 1:64 (N=274)21.2 (16.5 to 26.5)
1 month after Vac 3: PMB3040[A07] 1:64 (N=277)72.9 (67.3 to 78.1)
Before Vaccination 1: PMB3040[A07] 1:128 (N=274)4.0 (2.0 to 7.1)
1 month after Vac 3: PMB3040[A07] 1:128 (N=277)29.2 (24.0 to 35.0)
Before Vaccination 1: PMB824[A12] 1:4 (N=278)10.4 (7.1 to 14.6)
1 month after Vac 3: PMB824[A12] 1:4 (N=275)73.8 (68.2 to 78.9)
Before Vaccination 1: PMB824[A12] 1:8 (N=278)8.3 (5.3 to 12.2)
1 month after Vac 3: PMB824[A12] 1:8 (N=275)73.5 (67.8 to 78.6)
Before Vaccination 1: PMB824[A12] 1:16 (N=278)5.0 (2.8 to 8.3)
1 month after Vac 3: PMB824[A12] 1:16 (N=275)71.3 (65.5 to 76.5)
Before Vaccination 1: PMB824[A12] 1:32 (N=278)2.2 (0.8 to 4.6)
1 month after Vac 3: PMB824[A12] 1:32 (N=275)46.5 (40.5 to 52.6)
Before Vaccination 1: PMB824[A12] 1:64 (N=278)0.0 (0.0 to 1.3)
1 month after Vac 3: PMB824[A12] 1:64 (N=275)15.6 (11.6 to 20.5)
Before Vaccination 1: PMB824[A12] 1:128 (N=278)0.0 (0.0 to 1.3)
1 month after Vac 3: PMB824[A12] 1:128 (N=275)3.3 (1.5 to 6.1)
Before Vaccination 1: PMB1672[A15] 1:4 (N=279)39.4 (33.7 to 45.4)
1 month after Vac 3: PMB1672[A15] 1:4 (N=279)91.8 (87.9 to 94.7)
Before Vaccination 1: PMB1672[A15] 1:8 (N=279)37.3 (31.6 to 43.2)
1 month after Vac 3: PMB1672[A15] 1:8 (N=279)91.8 (87.9 to 94.7)
Before Vaccination 1: PMB1672[A15] 1:16 (N=279)33.3 (27.8 to 39.2)
1 month after Vac 3: PMB1672[A15] 1:16 (N=279)91.4 (87.5 to 94.4)
Before Vaccination 1: PMB1672[A15] 1:32 (N=279)20.4 (15.9 to 25.6)
1 month after Vac 3: PMB1672[A15] 1:32 (N=279)82.4 (77.5 to 86.7)
Before Vaccination 1: PMB1672[A15] 1:64 (N=279)7.2 (4.4 to 10.9)
1 month after Vac 3: PMB1672[A15] 1:64 (N=279)54.5 (48.4 to 60.4)
Before Vaccination 1: PMB1672[A15] 1:128 (N=279)1.8 (0.6 to 4.1)
1 month after Vac 3: PMB1672[A15] 1:128 (N=279)19.0 (14.6 to 24.1)
Before Vaccination 1: PMB1989[A19] 1:4 (N=278)39.2 (33.4 to 45.2)
1 month after Vac 3: PMB1989[A19] 1:4 (N=284)96.1 (93.2 to 98.1)
Before Vaccination 1: PMB1989[A19] 1:8 (N=278)37.1 (31.4 to 43.0)
1 month after Vac 3: PMB1989[A19] 1:8 (N=284)96.1 (93.2 to 98.1)
Before Vaccination 1: PMB1989[A19] 1:16 (N=278)28.8 (23.5 to 34.5)
1 month after Vac 3: PMB1989[A19] 1:16 (N=284)95.8 (92.7 to 97.8)
Before Vaccination 1: PMB1989[A19] 1:32 (N=278)18.3 (14.0 to 23.4)
1 month after Vac 3: PMB1989[A19] 1:32 (N=284)92.3 (88.5 to 95.1)
Before Vaccination 1: PMB1989[A19] 1:64 (N=278)9.0 (5.9 to 13.0)
1 month after Vac 3: PMB1989[A19] 1:64 (N=284)77.5 (72.2 to 82.2)
Before Vaccination 1: PMB1989[A19] 1:128 (N=278)9.0 (5.9 to 13.0)
1 month after Vac 3: PMB1989[A19] 1:128 (N=284)49.6 (43.7 to 55.6)
Before Vaccination 1: PMB1256[B03] 1:4 (N=277)13.0 (9.3 to 17.5)
1 month after Vac 3: PMB1256[B03] 1:4 (N=273)86.8 (82.2 to 90.6)
Before Vaccination 1: PMB1256[B03] 1:8 (N=277)11.2 (7.7 to 15.5)
1 month after Vac 3: PMB1256[B03] 1:8 (N=273)86.4 (81.8 to 90.3)
Before Vaccination 1: PMB1256[B03] 1:16 (N=277)10.1 (6.8 to 14.3)
1 month after Vac 3: PMB1256[B03] 1:16 (N=273)85.3 (80.6 to 89.3)
Before Vaccination 1: PMB1256[B03] 1:32 (N=277)7.6 (4.8 to 11.4)
1 month after Vac 3: PMB1256[B03] 1:32 (N=273)78.4 (73.0 to 83.1)
Before Vaccination 1: PMB1256[B03] 1:64 (N=277)4.7 (2.5 to 7.9)
1 month after Vac 3: PMB1256[B03] 1:64 (N=273)56.4 (50.3 to 62.4)
Before Vaccination 1: PMB1256[B03] 1:128 (N=277)1.1 (0.2 to 3.1)
1 month after Vac 3: PMB1256[B03] 1:128 (N=273)30.8 (25.3 to 36.6)
Before Vaccination 1: PMB866[B09] 1:4 (N=277)24.5 (19.6 to 30.1)
1 month after Vac 3: PMB866[B09] 1:4 (N=274)78.5 (73.1 to 83.2)
Before Vaccination 1: PMB866[B09] 1:8 (N=277)23.5 (18.6 to 28.9)
1 month after Vac 3: PMB866[B09] 1:8 (N=274)77.0 (71.6 to 81.9)
Before Vaccination 1: PMB866[B09] 1:16 (N=277)18.8 (14.3 to 23.9)
1 month after Vac 3: PMB866[B09] 1:16 (N=274)73.4 (67.7 to 78.5)
Before Vaccination 1: PMB866[B09] 1:32 (N=277)11.9 (8.3 to 16.3)
1 month after Vac 3: PMB866[B09] 1:32 (N=274)52.6 (46.5 to 58.6)
Before Vaccination 1: PMB866[B09] 1:64 (N=277)4.7 (2.5 to 7.9)
1 month after Vac 3: PMB866[B09] 1:64 (N=274)27.7 (22.5 to 33.4)
Before Vaccination 1: PMB866[B09] 1:128 (N=277)1.1 (0.2 to 3.1)
1 month after Vac 3: PMB866[B09] 1:128 (N=274)12.8 (9.1 to 17.3)
Before Vaccination 1: PMB431[B15] 1:4 (N=274)44.9 (38.9 to 51.0)
1 month after Vac 3: PMB431[B15] 1:4 (N=276)97.1 (94.4 to 98.7)
Before Vaccination 1: PMB431[B15] 1:8 (N=274)43.8 (37.8 to 49.9)
1 month after Vac 3: PMB431[B15] 1:8 (N=276)96.7 (93.9 to 98.5)
Before Vaccination 1: PMB431[B15] 1:16 (N=274)41.2 (35.4 to 47.3)
1 month after Vac 3: PMB431[B15] 1:16 (N=276)96.7 (93.9 to 98.5)
Before Vaccination 1: PMB431[B15] 1:32 (N=274)23.7 (18.8 to 29.2)
1 month after Vac 3: PMB431[B15] 1:32 (N=276)84.4 (79.6 to 88.5)
Before Vaccination 1: PMB431[B15] 1:64 (N=274)8.0 (5.1 to 11.9)
1 month after Vac 3: PMB431[B15] 1:64 (N=276)56.5 (50.4 to 62.5)
Before Vaccination 1: PMB431[B15] 1:128 (N=274)1.5 (0.4 to 3.7)
1 month after Vac 3: PMB431[B15] 1:128 (N=276)22.5 (17.7 to 27.9)
Before Vaccination 1: PMB648[B16] 1:4 (N=270)24.4 (19.4 to 30.0)
1 month after Vac 3: PMB648[B16] 1:4 (N=273)79.1 (73.8 to 83.8)
Before Vaccination 1: PMB648[B16] 1:8 (N=270)21.9 (17.1 to 27.3)
1 month after Vac 3: PMB648[B16] 1:8 (N=273)78.0 (72.6 to 82.8)
Before Vaccination 1: PMB648[B16] 1:16 (N=270)18.9 (14.4 to 24.1)
1 month after Vac 3: PMB648[B16] 1:16 (N=273)76.6 (71.1 to 81.5)
Before Vaccination 1: PMB648[B16] 1:32 (N=270)11.9 (8.2 to 16.3)
1 month after Vac 3: PMB648[B16] 1:32 (N=273)61.2 (55.1 to 67.0)
Before Vaccination 1: PMB648[B16] 1:64 (N=270)7.4 (4.6 to 11.2)
1 month after Vac 3: PMB648[B16] 1:64 (N=273)34.4 (28.8 to 40.4)
Before Vaccination 1: PMB648[B16] 1:128 (N=270)1.9 (0.6 to 4.3)
1 month after Vac 3: PMB648[B16] 1:128 (N=273)16.8 (12.6 to 21.8)
SecondaryhSBA 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
Reported as:
Geometric mean · Titers
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
TitersGroup 1 rLP2086
PMB3175[A29]:Before Vaccination 1 (N=280)7.1 (6.4 to 8.0)
PMB3175[A29]:1 Month after Vaccination 3 (N=283)96.3 (86.9 to 106.9)
PMB3010[A06]:Before Vaccination 1 (N=275)10.3 (9.5 to 11.2)
PMB3010[A06]:1 Month after Vaccination 3 (N=275)69.9 (61.8 to 79.1)
PMB3040[A07]:Before Vaccination 1 (N=274)13.9 (12.0 to 16.0)
PMB3040[A07]:1 Month after Vaccination 3 (N=277)60.4 (54.6 to 66.8)
PMB824[A12]: Before Vaccination 1 (N=278)8.4 (8.2 to 8.6)
PMB824[A12]:1 Month after Vaccination 3 (N=275)20.6 (18.8 to 22.6)
PMB1672[A15]:Before Vaccination 1 (N=279)8.0 (7.1 to 9.0)
PMB1672[A15]:1 Month after Vaccination 3 (N=279)43.1 (38.4 to 48.4)
PMB1989[A19]:Before Vaccination 1 (N=278)12.1 (11.1 to 13.3)
PMB1989[A19]:1 Month after Vaccination 3 (N=284)87.3 (77.7 to 98.0)
PMB1256[B03]:Before Vaccination 1 (N=277)5.1 (4.7 to 5.6)
PMB1256[B03]:1 Month after Vaccination 3 (N=273)49.8 (42.2 to 58.7)
PMB866[B09]:Before Vaccination 1 (N=277)6.1 (5.5 to 6.7)
PMB866[B09]:1 Month after Vaccination 3 (N=274)23.3 (19.9 to 27.1)
PMB431[B15]:Before Vaccination 1 (N=274)9.1 (8.1 to 10.3)
PMB431[B15]:1 Month after Vaccination 3 (N=276)49.4 (44.6 to 54.8)
PMB648[B16]:Before Vaccination 1 (N=270)6.2 (5.5 to 6.9)
PMB648[B16]:1 Month after Vaccination 3 (N=273)26.5 (22.8 to 30.8)
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
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 participantsGroup 1 rLP2086
Before First Vaccination (N=1612)7.3 (6.0 to 8.6)
1 Month after Vaccination 2 (N=1620)64.5 (62.1 to 66.8)
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
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 participantsGroup 1 rLP2086
PMB80[A22] (N=1679)66.9 (64.6 to 69.2)
PMB2001[A56] (N=1637)85.9 (84.1 to 87.5)
PMB2948[B24] (N=1658)67.9 (65.6 to 70.2)
PMB2707[B44] (N=1686)55.5 (53.1 to 57.9)
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
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 participantsGroup 1 rLP2086
Before Vac 1: PMB80[A22] 1:16 (N=1704)33.6 (31.3 to 35.9)
1 month after Vac 2: PMB80[A22] 1:16 (N=1697)84.7 (82.9 to 86.4)
1 month after Vac 3: PMB80[A22] 1:16 (N=1714)93.5 (92.2 to 94.6)
Before Vac 1: PMB2001[A56] 1:8 (N=1657)32.2 (29.9 to 34.5)
1 month after Vac 2: PMB2001[A56] 1:8) (N=1701)97.4 (96.5 to 98.1)
1 month after Vac 3: PMB2001[A56] 1:8 (N=1708)99.4 (98.9 to 99.7)
Before Vac 1: PMB2948[B24] 1:8 (N=1696)33.1 (30.9 to 35.4)
1 month after Vac 2: PMB2948[B24] 1:8 (N=1685)86.5 (84.7 to 88.1)
1 month after Vac 3:PMB2948[B24] 1:8 (N=1702)95.1 (93.9 to 96.0)
Before Vac 1: PMB2707[B44] 1:8 (N=1716)11.0 (9.6 to 12.6)
1 month after Vac 2: PMB2707[B44] 1:8 (N=1693)68.3 (66.1 to 70.6)
1 month after Vac 3: PMB2707[B44] 1:8 (N=1703)87.4 (85.8 to 89.0)
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
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 participantsGroup 1 rLP2086
Before Vac 1: PMB80[A22] 1:4 (N=1704)42.1 (39.7 to 44.5)
1 month after Vac 2: PMB80[A22] 1:4 (N=1697)86.2 (84.5 to 87.8)
1 month after Vac 3: PMB80[A22] 1:4 (N=1714)94.3 (93.1 to 95.3)
Before Vac 1: PMB80[A22] 1:8 (N=1704)38.8 (36.5 to 41.2)
1 month after Vac 2: PMB80[A22] 1:8 (N=1697)85.7 (83.9 to 87.3)
1 month after Vac 3: PMB80[A22] 1:8 (N=1714)94.1 (92.9 to 95.2)
Before Vac 1: PMB80[A22] 1:32 (N=1704)19.7 (17.8 to 21.6)
1 month after Vac 2: PMB80[A22] 1:32 (N=1697)71.2 (69.0 to 73.3)
1 month after Vac 3: PMB80[A22] 1:32 (N=1714)85.5 (83.8 to 87.2)
Before Vac 1: PMB80[A22] 1:64 (N=1704)9.6 (8.3 to 11.1)
1 month after Vac 2: PMB80[A22] 1:64 (N=1697)49.9 (47.4 to 52.3)
1 month after Vac 3: PMB80[A22] 1:64 (N=1714)64.4 (62.1 to 66.7)
Before Vac 1: PMB80[A22] 1:128 (N=1704)3.4 (2.6 to 4.4)
1 month after Vac 2: PMB80[A22] 1:128 (N=1697)29.9 (27.8 to 32.2)
1 month after Vac 3: PMB80[A22] 1:128 (N=1714)41.7 (39.4 to 44.1)
Before Vac 1: PMB2001[A56] 1:4 (N=1657)35.9 (33.6 to 38.3)
1 month after Vac 2: PMB2001[A56] 1:4 (N=1701)97.8 (97.0 to 98.5)
1 month after Vac 3: PMB2001[A56] 1:4 (N=1708)99.4 (98.9 to 99.7)
Before Vac 1: PMB2001[A56] 1:16 (N=1657)30.4 (28.2 to 32.7)
1 month after Vac 2: PMB2001[A56] 1:16 (N=1701)97.1 (96.1 to 97.8)
1 month after Vac 3: PMB2001[A56] 1:16 (N=1708)99.2 (98.7 to 99.6)
Before Vac 1: PMB2001[A56] ] 1:32 (N=1657)24.4 (22.3 to 26.5)
1 month after Vac 2: PMB2001[A56] 1:32 (N=1701)92.8 (91.4 to 94.0)
1 month after Vac 3: PMB2001[A56] 1:32 (N=1708)97.2 (96.4 to 98.0)
Before Vac 1: PMB2001[A56] 1:64 (N=1657)16.4 (14.6 to 18.2)
1 month after Vac 2 :PMB2001[A56] 1:64 (N=1701)80.8 (78.9 to 82.7)
1 month after Vac 3 :PMB2001[A56] 1:64 (N=1708)90.5 (89.0 to 91.9)
Before Vac 1: PMB2001[A56] 1:128 (N=1657)7.1 (5.9 to 8.5)
1 month after Vac 2: PMB2001[A56] 1:128 (N=1701)56.6 (54.2 to 58.9)
1 month after Vac 3: PMB2001[A56] 1:128 (N=1708)73.7 (71.5 to 75.7)
Before Vac 1: PMB2948[B24] 1:4 (N=1696)35.0 (32.7 to 37.3)
1 month after Vac 2: PMB2948[B24] 1:4 (N=1685)87.2 (85.5 to 88.7)
1 month after Vac 3: PMB2948[B24] 1:4 (N=1702)95.8 (94.8 to 96.7)
Before Vac 1: PMB2948[B24] 1:16 (N=1696)29.5 (27.3 to 31.7)
1 month after Vac 2: PMB2948[B24] 1:16 (N=1685)83.7 (81.9 to 85.5)
1 month after Vac 3: PMB2948[B24] 1:16 (N=1702)93.2 (91.9 to 94.3)
Before Vac 1: PMB2948[B24] 1:32 (N=1696)18.1 (16.3 to 20.0)
1 month after Vac 2: PMB2948[B24] 1:32 (N=1685)65.6 (63.3 to 67.8)
1 month after Vac 3: PMB2948[B24] 1:32 (N=1702)75.1 (73.0 to 77.2)
Before Vac 1: PMB2948[B24] 1:64 (N=1696)8.4 (7.1 to 9.8)
1 month after Vac 2: PMB2948[B24] 1:64 (N=1685)40.4 (38.0 to 42.7)
1 month after Vac 3: PMB2948[B24] 1:64 (N=1702)48.8 (46.4 to 51.2)
Before Vac 1: PMB2948[B24] 1:128 (N=1696)3.3 (2.5 to 4.3)
1 month after Vac 2: PMB2948[B24] 1:128 (N=1685)22.8 (20.9 to 24.9)
1 month after Vac 3: PMB2948[B24] 1:128 (N=1702)27.8 (25.7 to 30.0)
Before Vac 1: PMB2707[B44] 1:4 (N=1716)14.5 (12.8 to 16.2)
1 month after Vac 2: PMB2707[B44] 1:4 (N=1693)71.5 (69.3 to 73.7)
1 month after Vac 3: PMB2707[B44] 1:4 (N=1703)89.7 (88.1 to 91.1)
Before Vac 1: PMB2707[B44] 1:16 (N=1716)7.8 (6.5 to 9.1)
1 month after Vac 2: PMB2707[B44] 1:16 (N=1693)61.0 (58.6 to 63.3)
1 month after Vac 3: PMB2707[B44] 1:16 (N=1703)83.3 (81.4 to 85.0)
Before Vac 1: PMB2707[B44] 1:32 (N=1716)4.3 (3.4 to 5.4)
1 month after Vac 2: PMB2707[B44] 1:32 (N=1693)41.9 (39.6 to 44.3)
1 month after Vac 3: PMB2707[B44] 1:32 (N=1703)67.1 (64.8 to 69.3)
Before Vac 1: PMB2707[B44] 1:64 (N=1716)2.3 (1.6 to 3.1)
1 month after Vac 2: PMB2707[B44] 1:64 (N=1693)30.3 (28.1 to 32.6)
1 month after Vac 3: PMB2707[B44] 1:64 (N=1703)49.8 (47.4 to 52.2)
Before Vac 1: PMB2707[B44] 1:128 (N=1716)0.8 (0.4 to 1.3)
1 month after Vac 2: PMB2707[B44] 1:128 (N=1693)21.0 (19.1 to 23.0)
1 month after Vac 3: PMB2707[B44] 1:128 (N=1703)32.1 (29.9 to 34.4)
SecondaryhSBA 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
Reported as:
Geometric mean · Titer
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
TiterGroup 1 rLP2086
PMB80[A22]: Before Vac 1 (N=1704)12.8 (12.3 to 13.3)
PMB80[A22]: 1 Month after Vac 2 (N=1697)49.0 (46.2 to 52.1)
PMB80[A22]: 1 Month after Vac 3 (N=1714)74.3 (70.2 to 78.6)
PMB2001[A56]: Before Vac 1 (N=1657)8.8 (8.3 to 9.3)
PMB2001[A56]: 1 Month after Vac 2 (N=1701)114.3 (107.9 to 121.0)
PMB2001[A56]: 1 Month after Vac 3 (N=1708)176.7 (167.8 to 186.1)
PMB2948[B24]: Before Vac 1 (N=1696)7.6 (7.3 to 8.0)
PMB2948[B24]: 1 Month after Vac 2 (N=1685)35.8 (33.7 to 38.2)
PMB2948[B24]: 1 Month after Vac 3 (N=1702)49.5 (46.8 to 52.4)
PMB2707[B44]: Before Vac 1 (N=1716)4.8 (4.7 to 4.9)
PMB2707[B44]: 1 Month after Vac 2 (N=1693)22.6 (20.9 to 24.4)
PMB2707[B44]: 1 Month after Vac 3 (N=1703)47.6 (44.2 to 51.3)
SecondaryPercentage 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

No measurements were reported for this outcome.

SecondaryPercentage 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
Reported as:
Number · Percentage of participants
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 participantsGroup 1 rLP2086
PMB80[A22]: 1 Month after Vac 3 (N=1695)89.0 (87.4 to 90.4)
PMB2001[A56]: 1 Month after Vac 3 (N=1642)95.3 (94.2 to 96.3)
PMB2948[B24]: 1 Month after Vac 3 (N=1675)87.1 (85.4 to 88.7)
PMB2707[B44]: 1 Month after Vac 3(N=1696)81.8 (79.9 to 83.6)

Adverse events

Collected over AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1 rLP2086—33/2,471 (1.3%)2,193/2,471 (88.7%)
Group 2 Saline—11/822 (1.3%)567/822 (69%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventGroup 1 rLP2086Group 2 Saline
MigraineNervous system disorders0/24712/822
Abortion spontaneousPregnancy, puerperium and perinatal conditions4/24711/822
Sudden hearing lossEar and labyrinth disorders0/24711/822
Abdominal pain upperGastrointestinal disorders0/24711/822
GastritisGastrointestinal disorders0/24711/822
Cholecystitis acuteHepatobiliary disorders0/24711/822
AppendicitisInfections and infestations2/24711/822
CystitisInfections and infestations1/24711/822
SyncopeNervous system disorders0/24711/822
DepressionPsychiatric disorders0/24711/822
Most frequent other events
Showing 10 of 23
Most frequent other events
EventGroup 1 rLP2086Group 2 Saline
Pain at injection site - Any (reactogenicity event)Skin and subcutaneous tissue disorders2184/2438147/808
Fatigue -Any (reactogenicity event)General disorders1576/2438411/808
Headache - Any (reactogenicity event)General disorders1440/2438391/808
Muscle pain -Any (reactogenicity event)General disorders916/2438170/808
Joint pain -Any (reactogenicity event)General disorders723/2438136/808
Chills - Any (reactogenicity event)General disorders697/2438133/808
Swelling -Any (reactogenicity event)Skin and subcutaneous tissue disorders612/24388/808
Redness -Any (reactogenicity event)Skin and subcutaneous tissue disorders537/24388/808
Diarrhea-Any (reactogenicity event)General disorders497/2438158/808
Vomiting - Any (reactogenicity event)General disorders130/243837/808

Baseline characteristics

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

Age, Continuous
Age, Continuous(Years)Group 1 rLP2086Group 2 SalineTotal
Mean21.47 ± 2.1421.52 ± 2.2021.48 ± 2.15
Sex: Female, Male
Sex: Female, Male(Participants)Group 1 rLP2086Group 2 SalineTotal
Female14524821934
Male10193401359
08

Study locations

58 sites
  • Coastal Clinical Research, Inc.
    Mobile, Alabama 36608, United States
  • Clinical Research Advantage, Inc./Desert Clinical Research, LLC
    Mesa, Arizona 85213, United States
  • Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
    Tempe, Arizona 85282, United States
  • Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
    Tempe, Arizona 85283, United States
  • Anaheim Clinical Trials LLC
    Anaheim, California 92801, United States
  • eStudySite
    La Mesa, California 91942, United States
  • Benchmark Research
    Sacramento, California 95822, United States
  • Broward Research Group
    Hollyood, Florida 33024, United States
  • Altus Research Inc.
    Lake Worth, Florida 33461, United States
  • Miami Research Associates
    South Miami, Florida 33143, United States
  • Palm Beach Research Center
    West Palm Beach, Florida 33409, United States
  • Johnson County Clin-Trials, Inc.
    Lenexa, Kansas 66219, United States
  • Benchmark Research
    Metairie, Louisiana 70006, United States
  • Milford Emergency Associates, Inc.
    Milford, Massachusetts 01757, United States
  • The Center for Pharmaceutical Research
    Kansas City, Missouri 64114, United States
  • Bellevue Urgent Care
    Bellevue, Nebraska 68005, United States
  • Meridian Clinical Research
    Bellevue, Nebraska 68005, United States
  • Pioneer Clinical Research, LLC
    Bellevue, Nebraska 68005, United States
  • Meridian Clinical Research,
    Omaha, Nebraska 68134, United States
  • Central New York Clinical Research
    Manlius, New York 13104, United States
  • PMG Research of Raleigh, LLC
    Raleigh, North Carolina 27609, United States
  • Community Research
    Cincinnati, Ohio 45227, United States
  • Rapid Medical Research, Inc.
    Cleveland, Ohio 44122, United States
  • Rapid Medical Research
    Cleveland, Ohio 44122, United States
  • PEAK Research, LLC
    Upper St. Clair, Pennsylvania 15241, United States
  • Coastal Medical
    East Greenwich, Rhode Island 02818, United States
  • Omega Medical Research
    Warwick, Rhode Island 02886, United States
  • Coastal Carolina Research Center
    Mt. Pleasant, South Carolina 29464, United States
  • Meridian Clinical Research
    Dakota Dunes, South Dakota 57049, United States
  • Clinical Research Associates, Inc.
    Nashville, Tennessee 37203, United States
  • Research Across America
    Dallas, Texas 75234, United States
  • Texas Center for Drug Development, Inc.
    Houston, Texas 77081, United States
  • Research Across America
    Katy, Texas 77450, United States
  • Advanced Clinical Research
    West Jordan, Utah 84088, United States
  • Premier Clinical Research
    Spokane, Washington 99204-4880, United States
  • Dr. Calvin Powell Professional Medical Corporation
    Bay Roberts, Newfoundland and Labrador A0A 1G0, Canada
  • Canadian Center for Vaccinology - IWK Health Centre
    Halifax, Nova Scotia B3K 6R8, Canada
  • Milestone Research
    London, Ontario N5W 6A2, Canada
  • London Road Diagnostic Clinic and Medical Centre
    Sarnia, Ontario N7T 4X3, Canada
  • Devonshire Clinical Research Inc.
    Woodstock, Ontario N4S 5P5, Canada
  • McGill University Health Centre - Vaccine Study Centre
    Pierrefonds, Quebec H9H 4Y6, Canada
  • Clinique Medicale St-Louis Inc.
    Sainte-Foy, Québec, Quebec G1W 4R4, Canada
  • Pro-Recherche Inc.
    St-Romuald, Quebec G6W 5M6, Canada
  • Centre hospitalier universitaire de Québec
    Quebec, G1E 7G9, Canada
  • Aarhus Universitetshospital Skejby
    Aarhus N, 8200, Denmark
  • Espoo Vaccine Research Clinic
    Espoo, 02230, Finland
  • Helsinki South Vaccine Research Clinic
    Helsinki, 00100, Finland
  • Kokkola Vaccine Research Clinic
    Kokkola, 67100, Finland
  • Seinäjoki Vaccine Research Clinic
    Seinäjoki, 60100, Finland
  • NZOZ Centrum Medyczne Graniczna Sp. z o.o.
    Katowice, 40-018, Poland
  • Specjalistyczna Poradnia Medyczna Przyladek Zdrowia
    Krakow, 30-438, Poland
  • NZOZ Salmed s.c.
    Leczna, 21-010, Poland
  • CAP Balenya
    Balenya, Barcelona 08550, Spain
  • CAP Centelles
    Centelles, Barcelona 08540, Spain
  • Hospital Universitari de Bellvitge
    Hospitalet de Llobregat, Barcelona 08907, Spain
  • CAP El Remei
    Vic, Barcelona 08500, Spain
  • Hospital Clinic de Barcelona
    Barcelona, 08036, Spain
  • FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO
    Valencia, 46015, Spain
09

References and documents

Publications

  • Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11. PubMed 35164991 ↗
  • Beeslaar J, Absalon J, Anderson AS, Eiden JJ, Balmer P, Harris SL, Jones TR, O'Neill RE, Pregaldien JL, Radley D, Maansson R, Ginis J, Srivastava A, Perez JL. MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies. Infect Dis Ther. 2020 Sep;9(3):641-656. doi: 10.1007/s40121-020-00319-0. Epub 2020 Jul 22. PubMed 32700260 ↗
  • Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17. PubMed 32681472 ↗
  • Ostergaard L, Vesikari T, Absalon J, Beeslaar J, Ward BJ, Senders S, Eiden JJ, Jansen KU, Anderson AS, York LJ, Jones TR, Harris SL, O'Neill R, Radley D, Maansson R, Pregaldien JL, Ginis J, Staerke NB, Perez JL; B1971009 and B1971016 Trial Investigators. A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults. N Engl J Med. 2017 Dec 14;377(24):2349-2362. doi: 10.1056/NEJMoa1614474. PubMed 29236639 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01352845
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 12, 2011
Start date
May 2013
Primary completion
Feb 2015
Completion
Feb 2015
Results posted
Feb 23, 2016
Last update
Feb 23, 2016

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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