Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rLP2086 and Gardasil · 2 trials · 2 indications
Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.
Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.
Antibody hSBA GMTs of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
| Arm | Type | Description |
|---|---|---|
| MCV4 + Tdap+ rLP2086 | ACTIVE_COMPARATOR | Group 1 - MCV4 + Tdap + rLP2086 |
| MCV4 + Tdap + saline | ACTIVE_COMPARATOR | Group 2, MCV4 + Tdap+ saline |
| Saline + saline + rLP2086 | PLACEBO_COMPARATOR | Group 3- rLP2086 + saline |
| Group 1 | ACTIVE_COMPARATOR | rLP2086 + Gardasil |
| Group 2 | PLACEBO_COMPARATOR | rLP2086 and saline |
| Group 3 | ACTIVE_COMPARATOR | Saline + Gardasil |
| Name | Type | Description |
|---|---|---|
| rLP2086 + MCV4 + Tdap | BIOLOGICAL | At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086. |
| MCV4 + Tdap + saline | BIOLOGICAL | At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only. |
| rLP2086 + saline | BIOLOGICAL | At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6). |
| rLP2086 and Gardasil | BIOLOGICAL | Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6. |
| rLP2086 | BIOLOGICAL | Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6. |
| Gardasil | BIOLOGICAL | Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6. |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study. * Parent /legally authorized representative and subjects who are willing and...
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.