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

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

Trials by US State

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−

Trials by US State for TRUMENBA
Location	Trials
Idaho	1
Florida	1
California	1
Alabama	1
Utah	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: Clinical Trials, Market Analysis, and Projections

Introduction to TRUMENBA

TRUMENBA, developed by Pfizer, is a meningococcal group B vaccine designed to protect against invasive disease caused by Neisseria meningitidis serogroup B (MenB). This vaccine has undergone extensive clinical trials and has been approved in several regions, including the U.S., Europe, Australia, and Canada.

Clinical Trials of TRUMENBA

Phase 3 Clinical Trials

The clinical trials for TRUMENBA were pivotal in demonstrating its immunogenicity. Two Phase 3 randomized, controlled, multicenter clinical trials were conducted, involving nearly 7,000 healthy adolescents and young adults aged 10 to 25 years in the U.S., Europe, and Canada. These trials showed that TRUMENBA, administered on a three-dose schedule (0, 2, and 6 months), elicited a protective immune response against diverse MenB strains[1][3].

Safety Evaluation

The safety of TRUMENBA was evaluated in seven clinical trials, enrolling 4,282 subjects aged 11 to 35 years. These trials included four randomized and controlled studies, as well as three supportive non-controlled studies conducted in the U.S., Europe, and Australia. The results indicated that TRUMENBA was generally well-tolerated, with common adverse reactions including pain, redness, and swelling at the injection site[3].

Ongoing Studies

Despite the FDA's accelerated approval, Pfizer continues to conduct studies to further assess the vaccine’s effectiveness against diverse MenB strains. For instance, a Phase 3 study aimed to collect additional data on the use of TRUMENBA and its combination with other meningococcal vaccines, such as MenABCWY[4].

Market Analysis of TRUMENBA

Global Market Size and Growth

The global meningococcal vaccines market, which includes TRUMENBA, was valued at USD 3.28 billion in 2022 and is projected to grow at a CAGR of 6.0% from 2023 to 2030. TRUMENBA is expected to grow at the fastest rate within this market due to increasing awareness of the disease and expanding marketing approvals globally[5].

Revenue Forecasts

The meningococcal vaccines market, including TRUMENBA, is forecasted to surpass USD 3.1 billion in 2024. The market is expected to grow significantly, driven by government initiatives and the rising prevalence of meningitis. TRUMENBA's market forecast from 2024 to 2034 indicates a strong growth trajectory, particularly in regions like North America and Europe where MenB is a predominant cause of meningococcal disease[2][5].

Distribution Channels

The public sales channel segment holds the largest market share, accounting for 69.4% in 2022. This dominance is attributed to the inclusion of major meningococcal vaccine brands, such as TRUMENBA, in immunization programs. Hospital pharmacies, retail pharmacies, and online pharmacies are also significant distribution channels, with forecasts indicating continued growth in these segments[2][5].

Regional Market

TRUMENBA's market is forecasted to grow in various regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. In North America and Europe, where MenB is a major cause of meningococcal disease, TRUMENBA is expected to see significant demand. Countries like the U.S., Canada, Germany, France, and the U.K. are key markets for this vaccine[2][5].

Market Projections

Serotype B Dominance

The serotype B segment, which includes TRUMENBA and Bexsero, dominated the global market with a revenue share of 36.3% in 2022. This dominance is expected to continue due to the high disease burden of MenB and the strong presence of these vaccines in the market[5].

Brand Outlook

TRUMENBA, along with other major brands like Bexsero, Menactra, Menveo, and Nimenrix, is expected to drive market growth. The brand outlook indicates that TRUMENBA will continue to be a significant player in the meningococcal vaccines market, driven by its effectiveness and expanding approvals[5].

Age Group and Sales Channel

TRUMENBA is primarily targeted at adolescents and young adults aged 10 to 25 years. The public sales channel, which includes immunization programs, is the largest segment and is expected to maintain its dominance throughout the forecast period[5].

Key Takeaways

• Clinical Trials: TRUMENBA has demonstrated immunogenicity and safety in extensive Phase 3 clinical trials.
• Market Growth: The global meningococcal vaccines market, including TRUMENBA, is projected to grow at a CAGR of 6.0% from 2023 to 2030.
• Revenue Forecasts: TRUMENBA's market is expected to surpass significant revenue milestones, driven by government initiatives and increasing disease awareness.
• Distribution Channels: Public sales channels, including hospital and retail pharmacies, will continue to be major distribution points.
• Regional Market: North America and Europe are key regions for TRUMENBA's growth due to the high prevalence of MenB.

FAQs

Q: What is TRUMENBA used for?

A: TRUMENBA is used for the active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B (MenB) in individuals aged 10 through 25 years.

Q: How is TRUMENBA administered?

A: TRUMENBA can be administered as a two- or three-dose schedule depending on an individual’s risk of exposure and susceptibility to MenB.

Q: What were the outcomes of the Phase 3 clinical trials for TRUMENBA?

A: The Phase 3 trials demonstrated that TRUMENBA elicits a protective immune response against diverse MenB strains, meeting all five co-primary immunogenicity endpoints.

Q: What are the common adverse reactions associated with TRUMENBA?

A: Common adverse reactions include pain, redness, and swelling at the injection site.

Q: What is the projected market growth for TRUMENBA?

A: The global meningococcal vaccines market, including TRUMENBA, is projected to grow at a CAGR of 6.0% from 2023 to 2030, with TRUMENBA expected to grow at the fastest rate within this market.