Phase 3
Completed N=3,590
A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
Meningococcal Vaccine
Source: ClinicalTrials.gov NCT01830855 ↗
Enrolled (actual)
3,590
Serious AEs
2.0%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 — 83.5; 83.2; 90.2; 79.8 percentage of participants
◆ Published Evidence
Established
71citations · ~8 / year
A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults.
Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Linked Publications (4)
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A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults.
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MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies.
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Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data.
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Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 |
83.5; 83.2; 90.2; 79.8; 85.9 | — |
| PRIMARY hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine |
86.8; 84.3; 85.1; 24.1; 25.3; 25.2 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination |
86.7; 47.0; 41.1; 36.5; 40.7; 9.9 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination |
77.7; 15.2; 39.4; 12.3; 33.2; 2.7 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination |
76.0; 34.0; 34.1; 23.8; 36.5; 9.9 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination |
6.4; 1.9; 4.0; 1.3; 1.9; 0.3 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination |
2.0; 1.5; 1.2; 0.7; 0.7; 0.7 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination |
2.7; 2.3; 1.8; 1.3; 0.6; 0.4 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination |
0.26; 0.33 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination |
0.23; 0.23 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination |
0.32; 0.36 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination |
0.78; 0.89 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase |
1.49; 1.90 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase |
0.44; 0.60 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period |
1.89; 2.45 | — |
| PRIMARY Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination |
5.27; 6.69 | — |
| PRIMARY Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination |
5.91; 6.51 | — |
| PRIMARY Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination |
5.81; 7.43 | — |
| PRIMARY Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination |
14.18; 16.61 | — |
| PRIMARY Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase |
25.29; 27.87 | — |
| PRIMARY Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase |
15.61; 16.92 | — |
| PRIMARY Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period |
32.38; 35.56 | — |
| PRIMARY Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination |
0.00; 0.11 | — |
| PRIMARY Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination |
0.08; 0.12 | — |
| PRIMARY Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination |
0.12; 0.00 | — |
| PRIMARY Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination |
0.19; 0.22 | — |
| PRIMARY Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase |
0.37; 0.56 | — |
| PRIMARY Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase |
0.20; 0.60 | — |
| PRIMARY Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period |
0.56; 1.11 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination |
9.51; 10.70 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination |
11.48; 12.67 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination |
9.91; 10.78 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination |
25.32; 26.76 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase |
40.74; 43.70 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination |
0.1; 0.2 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination |
0.2; 0.1 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination |
0.1; 0.0 | — |
| PRIMARY Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase |
3.9; 4.0 | — |
| SECONDARY Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 |
17.5; 98.6; 9.4; 95.7; 43.1; 96.4 | — |
| SECONDARY Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 |
19.0; 98.6; 17.5; 98.6; 16.7; 98.6 | — |
| SECONDARY hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 |
5.7; 93.5; 9.3; 78.6; 11.4; 63.5 | — |
| SECONDARY Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1 |
1.1; 54.1 | — |
| SECONDARY Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 |
73.8; 84.8; 56.2; 55.9 | — |
| SECONDARY Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination |
71.2; 74.6; 83.8; 86.0; 56.7; 56.8 | — |
| SECONDARY hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination |
12.6; 12.9; 12.2; 50.4; 47.7; 49.6 | — |
| 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 |
33.2; 34.9; 31.7; 94.3; 92.7; 94.7 | — |
| SECONDARY Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination |
36.2; 39.6; 36.7; 94.9; 93.7; 95.5 | — |
| SECONDARY Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination |
— | — |
| SECONDARY Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination |
91.43; 92.02; 93.51; 95.04; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subject aged >=10 and <19 years at the time of enrollment.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- Negative urine pregnancy test for all female subjects.
Exclusion Criteria
- Previous vaccination with any meningococcal serogroup B vaccine.
- Subjects who have received prior HAV vaccination.
- 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.
- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- 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.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Data sourced from ClinicalTrials.gov (NCT01830855) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.