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Last Updated: January 2, 2025

CLINICAL TRIALS PROFILE FOR BEXSERO


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All Clinical Trials for BEXSERO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02491463 ↗ A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults Completed GlaxoSmithKline Phase 1 2015-07-23 The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.
NCT03636906 ↗ Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV Completed GlaxoSmithKline Phase 1 2019-04-08 The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV, and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.
NCT04318548 ↗ Study to Assess the Immunogenicity and Safety of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age Not yet recruiting GlaxoSmithKline Phase 3 2020-05-04 The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
NCT04502693 ↗ Study to Assess Effectiveness of GlaxoSmithKline's (GSK's) Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults. Not yet recruiting GlaxoSmithKline Phase 3 2020-08-14 The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety will also be evaluated in the study.
NCT04597424 ↗ Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP) Recruiting ANRS, Emerging Infectious Diseases Phase 3 2021-01-19 The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.
NCT04597424 ↗ Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP) Recruiting French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Phase 3 2021-01-19 The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.
NCT04645966 ↗ A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants Recruiting Pfizer Phase 2 2020-11-26 The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BEXSERO

Condition Name

Condition Name for BEXSERO
Intervention Trials
Infections, Meningococcal 2
Pneumococcal Infections 1
Respiratory Synctial Virus Infections 1
Respiratory Syncytial Virus Infections 1
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Condition MeSH

Condition MeSH for BEXSERO
Intervention Trials
Meningococcal Infections 3
Infections 3
Infection 2
Virus Diseases 2
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Clinical Trial Locations for BEXSERO

Trials by Country

Trials by Country for BEXSERO
Location Trials
United States 15
Spain 7
Canada 3
United Kingdom 2
Brazil 2
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Trials by US State

Trials by US State for BEXSERO
Location Trials
Kentucky 2
Idaho 2
California 1
Alabama 1
Maryland 1
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Clinical Trial Progress for BEXSERO

Clinical Trial Phase

Clinical Trial Phase for BEXSERO
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for BEXSERO
Clinical Trial Phase Trials
Not yet recruiting 4
Recruiting 4
Completed 2
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Clinical Trial Sponsors for BEXSERO

Sponsor Name

Sponsor Name for BEXSERO
Sponsor Trials
GlaxoSmithKline 5
National Institute of Allergy and Infectious Diseases (NIAID) 1
University of North Carolina, Chapel Hill 1
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Sponsor Type

Sponsor Type for BEXSERO
Sponsor Trials
Industry 7
Other 4
NIH 1
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BEXSERO Market Analysis and Financial Projection

BEXSERO: Clinical Trials, Market Analysis, and Projections

Introduction to BEXSERO

BEXSERO, developed by GSK, is a meningococcal group B vaccine designed to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B. It has been licensed or received regulatory approval in 55 countries, including the US and EU, and is used in 16 national immunization programs worldwide[2].

Clinical Trials Overview

Initial Approval and Post-Marketing Requirements

BEXSERO was initially approved under the FDA’s Accelerated Approval pathway in January 2015. This approval was contingent on the completion of several post-marketing studies to confirm the vaccine's effectiveness and breadth of coverage against diverse meningococcal serogroup B strains[1][3].

Key Clinical Studies

  • Study V102_16: This study aimed to assess the performance of immunologic assays for evaluating the breadth of coverage against diverse Neisseria meningitidis serogroup B strains. The study was completed in May 2015, and the final report was submitted in March 2016[1][3].
  • Study V72_72: This study was designed to confirm the effectiveness of BEXSERO against a panel of diverse Neisseria meningitidis serogroup B strains among persons aged 10 through 25 years. The study completion date was December 31, 2017, with the final report submitted by December 31, 2018[1][3].

Pediatric Studies

Under the Pediatric Research Equity Act (PREA), GSK conducted several studies to evaluate the safety and immunogenicity of BEXSERO in younger populations:

  • Study V72_57: This study evaluated BEXSERO in infants 6 weeks through 12 months of age. The study completion date was revised to August 31, 2025, with the final report submission deferred until June 30, 2026[1][3].
  • Study V72_28: This study assessed BEXSERO in infants 2.5 months through 11 months of age and in children 2 years through 10 years of age. The study was completed, and the final report was submitted by December 30, 2015[3].

Safety and Adverse Reactions

The safety of BEXSERO was evaluated in five clinical studies involving 4,861 participants aged 10 through 25 years. Common adverse reactions included headache, nausea, erythema, myalgia, and swelling. Serious adverse events were reported in 2.1% of participants, with none considered related to the vaccine in the controlled trials[4].

Post-Marketing Safety Experience

In response to meningococcal disease outbreaks at two US universities, BEXSERO was administered to 15,351 individuals aged 16 through 65 years. Serious adverse events were reported in 0.3% of the participants, including one case of anaphylaxis considered related to the vaccination[4].

Market Analysis and Projections

Market Growth

The meningococcal vaccines market, driven in part by BEXSERO, is projected to grow at a compound annual growth rate (CAGR) of 5.4% to reach $1.8 billion by 2025, up from $1.1 billion in 2015. This growth is attributed to changes in national immunization schedules and the introduction of more inclusive vaccination schedules for infants and adolescents[5].

GSK's Market Position

GSK is expected to become the leading provider of meningococcal vaccines by the end of the forecast period, surpassing Sanofi. BEXSERO is anticipated to contribute significantly to this growth, with projected sales of over $570 million in 2025. Additionally, GSK's novel pentavalent vaccine, MenABCWY, is expected to launch in the US and several European countries, further boosting market share[5].

Regulatory Acceptance

GSK's 5-in-1 meningococcal ABCWY vaccine candidate has been accepted for regulatory review by the US FDA, which could further solidify GSK's position in the market[2].

Global Impact and Adoption

BEXSERO has been integrated into national immunization programs in 16 countries worldwide, highlighting its global acceptance and the critical role it plays in preventing IMD caused by Neisseria meningitidis serogroup B[2].

Key Takeaways

  • BEXSERO has undergone extensive clinical trials to confirm its effectiveness and safety.
  • Post-marketing studies have been completed or are ongoing to fulfill FDA requirements.
  • The vaccine has a favorable safety profile with common adverse reactions being mild.
  • The meningococcal vaccines market is projected to grow significantly, driven by changes in immunization schedules and new vaccine launches.
  • GSK is expected to lead the market with BEXSERO and its upcoming pentavalent vaccine.

Frequently Asked Questions (FAQs)

What is BEXSERO used for?

BEXSERO is used for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years.

What were the key clinical studies for BEXSERO?

Key studies included V102_16 to assess immunologic assays and V72_72 to confirm effectiveness against diverse serogroup B strains.

What are the common adverse reactions to BEXSERO?

Common adverse reactions include headache, nausea, erythema, myalgia, and swelling.

How is the market for meningococcal vaccines projected to grow?

The market is projected to grow at a CAGR of 5.4% to reach $1.8 billion by 2025, driven by changes in national immunization schedules.

What is GSK's expected market position by 2025?

GSK is expected to become the leading provider of meningococcal vaccines, surpassing Sanofi, driven by the success of BEXSERO and the launch of its pentavalent vaccine.

Cited Sources:

  1. FDA Approval Letter - BEXSERO - August 19, 2024
  2. GSK's 5-in-1 Meningococcal ABCWY Vaccine Candidate - GSK Press Release, April 16, 2024
  3. Bexsero; Meningococcal Group B Vaccine Memorandum - FDA, March 1, 2016
  4. BEXSERO (Meningococcal Group B Vaccine) injectable - FDA
  5. Meningococcal Vaccines Market Report - Clinical Trials Arena, June 9, 2016

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