Phase 2
N=396
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Meningococcal B Disease
Bottom Line
View on ClinicalTrials.gov: NCT02534935 ↗Enrolled (actual)
396
Serious AEs
3.8%
Results posted
Apr 2018
Primary outcome: Primary: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 — 88.9; 90.9; 91.1; 88.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rLP2086 vaccine (Biological); Pediatric HAV vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 |
88.9; 90.9; 91.1; 88.2; 3.2; 6.9 | — |
| PRIMARY Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 |
68.2; 50.0; 59.1; 50.9; 64.5; 57.7 | — |
| PRIMARY Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 |
45.5; 50.0; 47.7; 45.7; 60.7; 53.3 | — |
| PRIMARY Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 |
54.5; 59.1; 56.8; 51.9; 62.0; 57.1 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 |
40.9; 31.8; 36.4; 28.2; 27.3; 27.7 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 |
13.6; 9.1; 11.4; 14.3; 14.0; 14.2 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 |
4.5; 4.5; 4.5; 10.6; 14.8; 12.7 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 |
18.2; 45.5; 31.8; 38.2; 41.8; 40.0 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 |
18.2; 27.3; 22.7; 34.3; 34.3; 34.3 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 |
18.2; 40.9; 29.5; 25.0; 30.6; 27.8 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination |
36.4; 63.6; 50.0; 54.5; 61.8; 58.2 | — |
| PRIMARY Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase |
54.5; 77.3; 65.9; 68.2; 71.8; 70.0 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase |
4.5; 9.1; 6.8; 0.9; 3.7; 2.3 | — |
| PRIMARY Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3 |
4.5; 13.6; 9.1; 10.9; 6.4; 8.6 | — |
| SECONDARY Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 |
90.0; 89.6; 5.0; 10.0; 12.4; 3.4 | — |
| SECONDARY Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 |
90.0; 66.7; 78.9; 64.4; 84.0; 74.7 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains |
0.0; 0.0; 0.0; 4.3; 3.9; 4.1 | — |
| SECONDARY Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains |
8.0; 8.0; 8.0; 8.5; 8.3; 8.4 | — |
| SECONDARY Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination |
30.6; 29.3; 10.2; 22.4; 21.1; 4.8 | — |
| SECONDARY Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination |
10.2; 6.1; 3.4; 0.7; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination |
0.7; 0.7; 1.4; 4.8; 2.7; 7.5 | — |
| SECONDARY Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination |
13.6 | — |
| SECONDARY Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination |
0.0 | — |
| SECONDARY Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination |
2.9; 92.6; 15.2; 100.0; 7.2; 92.8 | — |
| SECONDARY Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination |
8.4; 112.1; 5.2; 248.3; 4.5; 48.3 | — |
Summary
The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.
Eligibility Criteria
Inclusion Criteria
- Male or female subject aged 12 to <15 months or 18 to <24 months during sentinel-cohort enrollment, Or,12 to <24 months during expanded-cohort enrollment.
- Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
- Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria
- Previous vaccination with any meningococcal serogroup B vaccine.
- Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
- Contraindication to vaccination with any HAV vaccine or known latex allergy.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- A known or suspected disorder 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 or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.
- History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
- Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
- Current chronic use of systemic antibiotics.
- Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
- Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Data sourced from ClinicalTrials.gov (NCT02534935). 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.