Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rLP2086 · 5 trials · 7 indications
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.
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.
| Arm | Type | Description |
|---|---|---|
| rLP2086 | EXPERIMENTAL | - |
| Control | PLACEBO_COMPARATOR | Steril normal saline solution |
| rLP2086 lot 1 | EXPERIMENTAL | - |
| rLP2086 lot 2 | EXPERIMENTAL | - |
| rLP2086 lot 3 | EXPERIMENTAL | - |
| Saline and Repevax | PLACEBO_COMPARATOR | Saline and Repevax |
| Group A | EXPERIMENTAL | 20ug Experimental |
| Group 2 | EXPERIMENTAL | 60ug Experimental |
| Group 3 | EXPERIMENTAL | 200ug Experimental |
| Group 4 | ACTIVE_COMPARATOR | Active comparator |
| Name | Type | Description |
|---|---|---|
| rLP2086 | BIOLOGICAL | 0.5 mL dose, given at 0, 2 and 6 months |
| Placebo | OTHER | 0.5 mL dose, given at 0, 2 and 6 months |
| Havrix (HAV) | BIOLOGICAL | 0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6. |
| Saline | BIOLOGICAL | 0.5 mL dose of sterile normal saline for injection. |
| Repevax | BIOLOGICAL | 0.5 mL dose, given at 0 months. |
Inclusion Criteria: 1. Male or female subject aged \>=18 and \<26 years at the time of enrollment. 2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 3. Negative urine pregnancy test for all female subjects. Exclusion Criteria: 1. Previous...
rLP2086 is an investigational vaccine being developed to prevent meningococcal disease caused by Neisseria meningitidis serogroup B. It is being studied in healthy individuals ranging from toddlers to adults, with clinical trials evaluating its use in adolescents, young adults, and laboratory workers at risk of exposure.
rLP2086 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to assess the safety, tolerability, and immunogenicity of this investigational vaccine.
rLP2086 has completed Phase 3 clinical development. A global Phase 3 safety study of the 120 mcg dose in adolescents and young adults aged 10 to 25 years has been completed, along with several Phase 2 trials. The vaccine remains investigational and is not yet approved.
rLP2086 has been studied in several completed trials, including NCT01323270, a Phase 2 trial in healthy subjects aged 11 to 19 years; NCT01352793, a Phase 3 safety study in 5,715 adolescents and young adults; NCT01768117, a Phase 2 trial in laboratory workers; and NCT02534935, a Phase 2 trial in healthy toddlers.
rLP2086 is a bivalent recombinant lipoprotein 2086 vaccine designed to target Neisseria meningitidis serogroup B. It contains two variants of the factor H binding protein, a surface protein of the bacteria, to elicit an immune response that protects against meningococcal B disease.
rLP2086 is also known as bivalent rLP2086 and is the same vaccine marketed under the brand name Trumenba. Pfizer developed this vaccine to protect against meningococcal serogroup B disease, and it has been studied across multiple age groups in clinical trials.