Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) / GSK - LARVOL DELTA

Penmenvy - a second pentavalent meningococcal vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Meningococcal Infections

PENMENVY, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY (Businesswire) - "GSK plc...today announced that the US Food and Drug Administration (FDA) has approved PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD)...The regulatory application was supported by positive results from two phase III trials [NCT04502693; NCT04707391], which evaluated the vaccine’s safety, tolerability, and immune response in over 4,800 participants aged 10-25 years. The safety data demonstrated that the vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines."

FDA approval • Immunology • Meningococcal Infections

Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults who had Previously Received a Meningococcal ACWY Vaccine: Phase 3, Randomized, Controlled Clinical Study. (PubMed, Clin Infect Dis) - P3 | "Immune responses against serogroups ACWY following one and two doses of investigational MenABCWY vaccine are non-inferior to those following MenACWY-CRM in MenACWY-primed adolescents and young adults. Robust immune responses were observed against MenB indicator strains after two MenABCWY doses administered 6 months apart."

Journal • P3 data • Infectious Disease • Meningococcal Infections

Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial. (PubMed, Lancet Infect Dis) - P3 | "This study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0-6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB. This investigational vaccine could provide broad meningococcal serogroup coverage in a simplified immunisation schedule, thus aiding the public health attempt in preventing invasive meningococcal disease due to five Neisseria meningitidis serogroups in adolescents and young adults."

Journal • P3 data • Infectious Disease • Meningococcal Infections

Public Health Impact of Introducing a Pentavalent Vaccine Against Invasive Meningococcal Disease in the United States. (PubMed, Pharmacoeconomics) - "A routinely recommended two-dose pentavalent vaccine, with doses administered 6 months apart at 16 years of age, alongside the routinely recommended MenACWY vaccine at 11 years of age, would improve the PHI and benefits of IMD vaccination to society."

Journal • Infectious Disease • Meningococcal Infections

4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults. (PubMed, Open Forum Infect Dis) - "In a phase 3 trial, 3651 healthy 10- to 25-year-old participants were randomized 5:5:9:1 to receive 4CMenB (0-6 schedule), 4CMenB (0-2-6 schedule), investigational MenABCWY vaccine, or control MenACWY-CRM vaccine...The 2-dose (0-2, 0-6) 4CMenB schedules met predefined criteria for success for both breadth of immune response endpoints against a diverse MenB strain panel, had comparable immunogenicity, and safety in line with the established 4CMenB safety profile. The 3-dose schedule provided no additional immunological benefit, supporting use of the 4CMenB 0-2 schedule."

Clinical • Journal • P3 data • Infectious Disease • Meningococcal Infections

Clinical Profile of GSK's Pentavalent Meningococcal ABCWY Vaccine: An Overview (IDWeek 2024) - No abstract available

Clinical • Infectious Disease • Meningococcal Infections

NARRATIVE REVIEW OF EXPERIENCE OF GSK MENINGOCOCCAL VACCINES IN THE US (ESPID 2024) - P3 | "A recent clinical trial assessed the performance of GSK's MenB and candidate MenABCWY vaccine against diverse strains in circulation. Funding: GlaxoSmithKline Biologicals SA."

Review • Infectious Disease • Meningococcal Infections

METHODS TO EVALUATE THE PERFORMANCE OF A MULTICOMPONENT MENINGOCOCCAL SEROGROUP B (MENB) VACCINE: THE ROLE OF IMMUNOLOGICAL VACCINE EFFECTIVENESS (ESPID 2024) - "In phase 3 trials, traditional hSBA against antigen-specific MenB strains was used to assess the immunogenicity of 4CMenB and MenB-FHbp, and the pentavalent MenABCWY vaccines...Funding: GlaxoSmithKline Biologicals SA. Acknowledgements: Business & Decision Life Sciences Medical Communication Service Center (Writer: J.Knowles)."

Infectious Disease • Meningococcal Infections

MenABCWY – 019: Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (clinicaltrials.gov) - P3 | N=1250 | Completed | Sponsor: GlaxoSmithKline | Trial completion date: May 2023 ➔ Sep 2023

Trial completion date • CNS Disorders • Infectious Disease • Meningococcal Infections

MenABCWY – 019: Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (clinicaltrials.gov) - P3 | N=1250 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Infectious Disease • Meningococcal Infections

Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents (clinicaltrials.gov) - P2b | N=300 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Infectious Disease • Meningococcal Infections

Public health perspective of a pentavalent meningococcal vaccine combining antigens of MenACWY-CRM and 4CMenB. (PubMed, J Infect) - "A pentavalent MenABCWY has the potential to provide further public health benefits through practical, broad IMD protection programmes encompassing serogroups A, B, C, W and Y, and is currently in late-stage development."

Journal • Review • CNS Disorders • Infectious Disease • Meningococcal Infections

MenABCWY – 019: Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (clinicaltrials.gov) - P3 | N=1206 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Infectious Disease • Meningococcal Infections

PUBLIC HEALTH PERSPECTIVE OF A PENTAVALENT MENINGOCOCCAL ABCWY VACCINE COMBINING ANTIGENIC COMPONENTS OF MENACWY-CRM AND 4CMENB VACCINES: PROGRESSING TOWARDS A MENINGOCOCCAL-FREE WORLD (ESPID 2022) - P3 | "Here, we discuss the potential public health impact of a pentavalent MenABCWY vaccine that combines the antigenic components of two established vaccines – MenACWY-CRM (Menveo®) and 4CMenB (Bexsero®), which were developed to help control the spread of meningococcal disease and help improve immunisation rates. Direct broad invasive meningococcal disease (IMD) protection of high-risk groups is important for effective routine immunisation programmes. There are potential advantages in combining the most prevalent serogroup antigens in a single vaccine. Since the introduction of combined quadrivalent vaccines, there has been a positive impact demonstrated over time on public health regarding IMD, with a decline in the incidence of combined IMD serogroups and an increase in immunisation rates."

Infectious Disease • Meningococcal Infections

Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents (clinicaltrials.gov) - P2b | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Aug 2026 ➔ Nov 2026 | Trial primary completion date: Aug 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • CNS Disorders • Infectious Disease • Meningococcal Infections

Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents (clinicaltrials.gov) - P2b | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study of Adolescents and Young Adults. (PubMed, mSphere) - P2 | "A licensed vaccine, MenACWY (Menveo), targets four of these meningococcal serogroups, and another vaccine, 4CMenB (Bexsero), targets serogroup B. A combined vaccine (MenABCWY) that targets all five serogroups is under development to simplify the vaccination schedule. Immunogenicity results for serogroup B across study groups suggest no major interference between the MenB and MenACWY vaccine components. This supports further development of the combined MenABCWY vaccine."

Clinical • Journal • P2 data • CNS Disorders • Immunology • Infectious Disease • Meningococcal Infections

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (clinicaltrials.gov) - P3; N=1206; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Oct 2022 ➔ Apr 2023; Trial primary completion date: Oct 2022 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Infectious Disease • Meningococcal Infections

Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents (clinicaltrials.gov) - P2b; N=300; Not yet recruiting; Sponsor: GlaxoSmithKline

Clinical • New P2b trial • CNS Disorders • Infectious Disease • Meningococcal Infections

Immunogenicity and safety of different schedules of the meningococcal ABCWY vaccine, with assessment of long-term antibody persistence and booster responses - results from two phase 2b randomized trials in adolescents. (PubMed, Hum Vaccin Immunother) - P2b | "Two phase 2b, randomized, multicenter studies were conducted (NCT02212457, NCT02946385) to assess the immunogenicity and safety of the MenABCWY vaccine as well as antibody persistence and response to a booster dose 2 years after the last vaccination, compared to 4CMenB vaccination. Antibodies persisted up to 2 years post-MenABCWY vaccination and a booster dose induced an anamnestic response as higher titers were observed in follow-on participants compared to the first-dose response in vaccine-naïve participants. MenABCWY had a clinically-acceptable safety profile, not different from that of 4CMenB."

Clinical • Journal • P2b data • Hepatology • Infectious Disease • Inflammation • Meningococcal Infections

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (clinicaltrials.gov) - P3; N=1206; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Jul 2022 ➔ Oct 2022; Trial primary completion date: Jul 2022 ➔ Oct 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Infectious Disease • Meningococcal Infections

Study to evaluate safety and immunogenicity of GSK’s meningococcal ABCWY vaccine when given to healthy adolescents and adults, previously vaccinated with meningococcal ACWY vaccine (clinicaltrialsregister.eu) - P3; N=1206; Sponsor: GlaxoSmithKline Biologics SA (GSK)

Clinical • New P3 trial • CNS Disorders • Dermatology • Infectious Disease

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (clinicaltrials.gov) - P3; N=1206; Recruiting; Sponsor: GlaxoSmithKline; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Infectious Disease

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (clinicaltrials.gov) - P3; N=1206; Not yet recruiting; Sponsor: GlaxoSmithKline

Clinical • New P3 trial • CNS Disorders • Infectious Disease