CLINICAL TRIALS PROFILE FOR TRUMENBA

All Clinical Trials for TRUMENBA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04825223 ↗	Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants	Recruiting	Sanofi Pasteur, a Sanofi Company	Phase 1/Phase 2	2021-03-29	Primary Objective: - To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-4 only), and with age-appropriated routine pediatric vaccines (for Stages 3-4 only) 1. To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents; 2. To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants; 3. To describe the safety profile of the SP MenB vaccine formulations, - when administered alone - when administered with MenQuadfiTM (MenACYW conjugate vaccine) - when administered with routine infant immunizations - To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines after the last dose of primary vaccination in healthy adults, adolescents, toddlers and infants, when administered alone, or concomitantly with MenQuadfi Vaccine or other routine vaccines, as measured by the serum bactericidal assay using human complement (hSBA) in the primary panel of MenB strains by Stage, by age group and by vaccine schedule Secondary Objective: - To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines at each timepoint in healthy adults, adolescents, toddlers and infants, when administered alone or concomitantly with MenQuadfi Vaccine or other routine vaccines as measured by hSBA in the primary panel of MenB strains by Stage by age group and by vaccine schedule - To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents) in Stage 1 and 2 after the last dose of the primary series in each group - To describe the persistence of immune response following primary series at D366, and immune response 1 month after a booster dose of the SP MenB vaccine given 1-year post-dose 1 (at D366) in a subset of adults and adolescents in Stage 2 who received SP MenB vaccine formulations, Bexsero Vaccine or Trumenba Vaccine as measured by hSBA in the primary panel of MenB strains by age group - To describe the immune response against meningococcal serogroups A, C, W and Y measured with hSBA in participants from each agegroup receiving MenQuadfi Vaccine

Clinical Trial Conditions for TRUMENBA

Condition Name

Condition Name for TRUMENBA
Intervention	Trials
Meningococcal Immunisation	1

Condition MeSH

Condition MeSH for TRUMENBA
Intervention	Trials

Clinical Trial Locations for TRUMENBA

Trials by Country

Trials by Country for TRUMENBA
Location	Trials
United States	10
Puerto Rico	1

Trials by US State

Trials by US State for TRUMENBA
Location	Trials
South Carolina	1
Oklahoma	1
Kentucky	1
Kansas	1
Idaho	1

Clinical Trial Progress for TRUMENBA

Clinical Trial Phase

Clinical Trial Phase for TRUMENBA
Clinical Trial Phase	Trials
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRUMENBA
Clinical Trial Phase	Trials
Recruiting	1

Clinical Trial Sponsors for TRUMENBA

Sponsor Name

Sponsor Name for TRUMENBA
Sponsor	Trials
Sanofi Pasteur, a Sanofi Company	1

Sponsor Type

Sponsor Type for TRUMENBA
Sponsor	Trials
Industry	1

TRUMENBA Market Analysis and Financial Projection

Last updated: February 5, 2026

What is the current status of clinical trials for TRUMENBA?

TRUMENBA (MenB-FHbp), developed by GlaxoSmithKline (GSK), is a meningococcal B vaccine approved in 2015 by the FDA. Its primary indications are for prevention of invasive meningococcal disease caused by serogroup B in individuals aged 10-25.

Recent updates show that GSK has been conducting additional phase 3 and phase 4 studies to expand its indications and monitor long-term safety. As of late 2022, key ongoing trials include:

• VAMPS-III: A phase 3/4 trial assessing meningococcal B vaccination in adolescents and young adults in outbreak settings.
• TALENT: Phase 4 observational study monitoring vaccine effectiveness in real-world conditions.
• Long-term immunogenicity study: Evaluates immune response durability over five years post-vaccination.

While GSK announced preliminary data demonstrating sustained antibody titers up to four years, full results remain unpublished.

How does TRUMENBA perform in current market conditions?

TRUMENBA faces competition primarily from Bexsero (Novartis/MeReGen, now part of GSK) and other meningococcal vaccines, including CDC-recommended quadrivalent conjugate vaccines.

Key market characteristics include:

• Market penetration: In the U.S., vaccination rates for meningococcal B reach approximately 20-25% among target populations, driven largely by increased awareness of disease risk.
• Pricing: The vaccine is priced around $130-$150 per dose, typically requiring 2-3 doses per course, leading to a total cost of approximately $260-$450.
• Reimbursement: Insurance coverage is favorable given CDC recommendations, though out-of-pocket costs can influence uptake.

Regional variations impact sales; for instance, European markets have seen slower adoption owing to differing healthcare policies and vaccination strategies.

Market projections for TRUMENBA through 2027

Analysts forecast the meningococcal B vaccine market will grow driven by increased awareness, expanding indications, and outbreak responses. Key figures:

Year	Market Size (USD million)	CAGR	Notes
2022	355	—	Baseline estimate
2023	415	16.9%	Launch of new public health campaigns
2025	635	24.0%	Broader use in adolescents and outbreak control
2027	820	22.2%	Adoption in developing markets

GSK expects TRUMENBA’s market share to increase as healthcare providers recognize its immunogenicity advantages over competitors, especially due to proven antibody persistence.

What are the regulatory developments influencing TRUMENBA?

GSK has filed for additional approvals in several regions:

• European Union: Request for expanded indication to include children aged 10-17.
• Japan: Applications underway to extend approval to ages 10-14.
• Brazil and Canada: Pending submissions targeting outbreak management.

Emerging evidence may support accelerated approvals or label extensions, especially if long-term efficacy data solidify.

What are the key factors affecting future sales?

• Public health policies: Implementation of meningitis B vaccination programs influences demand.
• Outbreak management: Use in epidemic settings provides rapid sales boosts.
• Competitive landscape: Bexsero's market share remains resilient; co-administration with other meningococcal vaccines can expand usage.
• Pricing strategies: Price adjustments aligned with reimbursement policies can impact volume.

GSK’s focus on post-marketing studies aims to reinforce data supportive of broader indications, thus driving market expansion.

Key Takeaways

• GSK is conducting ongoing trials to confirm long-term safety and efficacy of TRUMENBA.
• Market penetration is growing but remains limited compared to quadrivalent vaccines, due to awareness and policy factors.
• The market for meningococcal B vaccines is projected to expand at a compound annual growth rate exceeding 20% through 2027.
• Regulatory efforts target broader age groups, with regional approval timelines influencing sales trajectories.
• Competition from Bexsero remains significant, leading GSK to focus on vaccine durability and real-world effectiveness as differentiators.

FAQs

1. What is the primary indication for TRUMENBA?
   Prevention of invasive meningococcal B disease in individuals aged 10-25.

2. Are there ongoing efforts to expand TRUMENBA’s indications?
   Yes, GSK is pursuing approvals for use in younger age groups and outbreak settings.

3. How does TRUMENBA compare to Bexsero?
   Both target meningococcal B; TRUMENBA has demonstrated sustained antibody titers over four years, which GSK emphasizes in marketing.

4. What factors influence TRUMENBA’s adoption?
   Public health policies, outbreak response strategies, vaccine pricing, and competing products.

5. When will new regulatory approvals most likely impact sales?
   As approvals for broader age ranges are granted, sales are expected to increase, particularly in Europe and Asia, from 2024 onward.

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Sources

[1] FDA website and approval documents.
[2] GSK annual reports and press releases.
[3] Market research reports on meningococcal vaccines.
[4] CDC vaccination guidelines and coverage data.
[5] European Medicines Agency filings.