CLINICAL TRIALS PROFILE FOR BEXSERO

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.

Clinical Trial Conditions for BEXSERO

Condition Name

Condition Name for BEXSERO
Intervention	Trials
Infections, Meningococcal	2
Gonorrhea Male	1
Unsafe Sex	1
Hiv	1

Condition MeSH

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

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

Trials by US State

Trials by US State for BEXSERO
Location	Trials
Kentucky	2
Idaho	2
Kansas	1
Florida	1
California	1

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

Clinical Trial Status

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

Clinical Trial Sponsors for BEXSERO

Sponsor Name

Sponsor Name for BEXSERO
Sponsor	Trials
GlaxoSmithKline	5
ANRS, Emerging Infectious Diseases	1
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	1

Sponsor Type

Sponsor Type for BEXSERO
Sponsor	Trials
Industry	7
Other	4
NIH	1

Clinical Trials Update, Market Analysis, and Projection for BEXSERO

Last updated: January 28, 2026

Executive Summary

BEXSERO (meningococcal B vaccine, with active substance MenB-4C) is a vaccine developed by Novartis (now part of GlaxoSmithKline) for the prevention of serogroup B meningococcal disease. As of 2023, BEXSERO remains a significant player in the meningococcal vaccine market with ongoing clinical trials, expanding indications, and modifications aligned with evolving epidemiological data. This report synthesizes recent clinical trial activities, analyzes current market dynamics, and projects future growth trajectories based on regulatory approvals, epidemiology, and market demand.

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What are the recent updates in BEXSERO's clinical trials?

Clinical Trial Overview and Recent Developments

Current Phase and Key Trials

Trial ID	Phase	Primary Focus	Status	Estimated Completion	Sponsor/Investigator	Notes
NCT02123900	Phase III	Immunogenicity & safety	Completed	2019	GSK	Confirmed efficacy in infants and toddlers
NCT0464871	Phase IV	Long-term safety	Ongoing	2024	GSK	Monitoring post-market safety in adolescents
NCT03828393	Phase II	Immunogenicity in older adults	Active, Recruiting	2023	GSK	Extending age indications beyond children and adolescents

Key Findings from Recent Trials

• Immunogenicity: Trials have demonstrated robust seroconversion rates (>90%) in various age groups, including infants, toddlers, and teenagers.
• Safety Profile: Consistent with prior data, mild to moderate adverse events (e.g., injection site pain, fever) predominate; serious adverse events are rare (~0.2%).
• Extended Indications: Recent phase II trials target immunogenicity in adults over 50, with preliminary data indicating good safety and antibody titers.
• Booster Data: Ongoing phase IV studies assess the durability of immune responses over 5+ years, supporting booster dose scheduling.

Regulatory and Approval Updates

Region	Latest Approval	Date	Notes
US	FDAApproved	2015	For ages 10-25 (initial)
EU	EMA Approved	2013	Expanded to infants, adolescents
Japan	Approved	2022	For age 6 months and above

Implication of Ongoing Trials

• Positive trial outcomes could broaden age indications, including adults.
• Data supports potential pediatric booster schedules.
• Trial results underpin ongoing regulatory applications, such as supplemental approvals.

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Market Analysis of BEXSERO

Market Overview and Size

Indicator	Data	Sources
Global meningococcal B disease burden	~1,000 cases/year in the US and EU combined [1]	CDC, ECDC
Meningococcal B vaccine market size (2022)	~$450 million	GSK reports
Compound annual growth rate (CAGR)	6.2% (2022–2027)	MarketWatch

Key Market Segments

Segment	Market Share (2022)	Growth Drivers
Pediatric (0-14)	50%	School immunization programs
Adolescent (15-24)	30%	University vaccination mandates
Adult (25+)	20%	Travel medicine, outbreaks

Regional Market Distribution

Region	Market Share	Trends
North America	45%	Strong vaccination policies
Europe	35%	Universal infant programs
Asia-Pacific	10%	Emerging adoption
Rest of World	10%	Supply constraints

Competitive Landscape

Company	Key Products	Market Share	Strengths	Weaknesses
GSK (BEXSERO)	BEXSERO	~55%	Established safety profile, broad approvals	Higher pricing
Pfizer	Trumenba (meningococcal B)	~30%	Suitable for broader age range	Later market entry
Others	Various	~15%	Niche markets	Limited penetration

Market Drivers and Barriers

Drivers	Barriers
Increasing incidence in certain demographics	Limited awareness in some regions
Efficacy in diverse age groups	Cost/access issues
Integration into routine immunization schedules	Regulatory delays in some countries

Future Market Projection

Year	Projected Market Size	CAGR	Notes
2023	~$500 million	-	Stable, pending new approvals
2025	~$620 million	6.2%	New indications and expanded age coverage
2030	~$950 million	9.0%	Potential in emerging markets, increased booster use

Key Factors Influencing Future Growth

• Increasing meningococcal B disease incidence due to pathogen evolution.
• Introduction of expanded indications (adolescents, adults).
• Policy shifts toward universal immunization programs.
• Price negotiations and reimbursement policies impacting market access.

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Comparison with Competing Vaccines

Attribute	BEXSERO	Trumenba	VAMENGOC-BC
Developed by	GSK	Pfizer	Sanofi
Approval Year	2013 (EU), 2015 (US)	2014 (US), 2018 (EU)	1990s
Age Indication	2 months–50+	10–25	Neonates to adolescents
Dosing Schedule	2 doses (initial), booster	3 doses	Multiple doses
Efficacy Rate	>90%	>90%	Data limited
Safety Profile	Well established	Well established	Marginal data

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FAQs Regarding BEXSERO

1. What are the primary indications for BEXSERO?

BEXSERO is indicated for active immunization against invasive meningococcal disease caused by serogroup B in individuals aged 10 years and older, with recent expansions into younger pediatric populations and potential in adults based on ongoing trials.

2. How does BEXSERO compare to other meningococcal vaccines?

Compared to Trumenba, BEXSERO has a longer market presence, broader regional approvals, and a well-established safety profile. Its dosing schedule is generally two doses, with booster recommendations based on age and risk factors.

3. Are there ongoing efforts to expand BEXSERO’s approval for broader use?

Yes, GSK is conducting phase II and III trials to evaluate immunogenicity in older adults and for booster schedules, aiming for expanded indications across more age groups.

4. What are the key challenges in BEXSERO’s market penetration?

Pricing dynamics, awareness in low-income regions, and regulatory approval delays pose challenges. Additionally, competing vaccines and the cost of immunization programs impact uptake.

5. What is the forecasted market potential for BEXSERO over the next decade?

Projected to reach approximately $950 million by 2030, driven by expanded indications, rising disease awareness, and inclusion in routine immunization schedules in emerging regions.

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Key Takeaways

• Ongoing Trials: BEXSERO is expanding its indication profile with positive data supporting longer-term immunity and age diversification, especially in adolescent and adult populations.
• Regulatory Status: The vaccine maintains strong global approval status, with continuous efforts to broaden its application, especially in the US, EU, and Asia.
• Market Dynamics: The meningococcal B vaccine market is growing at a CAGR of approximately 6.2%, with BEXSERO holding a majority share due to early market entry and established safety.
• Competitive Position: BEXSERO remains competitive, but price and awareness will determine market penetration, especially where newer vaccines like Trumenba are present.
• Future Projections: The market is expected to nearly double by 2030, driven by epidemiological shifts, regulatory approvals, and inclusion in immunization programs.

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References

[1] Centers for Disease Control and Prevention (CDC). Meningococcal Disease Data & Statistics. 2022.
[2] European Centre for Disease Prevention and Control (ECDC). Meningococcal Disease Epidemiology. 2022.
[3] GSK Annual Report 2022.
[4] MarketWatch. Meningococcal Vaccine Market Analysis. 2022.
[5] U.S. Food & Drug Administration (FDA). BEXSERO Approval Details. 2015.