CLINICAL TRIALS PROFILE FOR MENINGOCOCCAL GROUP B VACCINE

All Clinical Trials for meningococcal group b vaccine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000820 ↗	A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
NCT00496015 ↗	Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A	Completed	GlaxoSmithKline	Phase 3	2007-07-02	The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612). This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).
NCT00935883 ↗	Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)	Completed	Alexion Pharmaceuticals	Phase 2	2009-07-01	To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy.

Clinical Trial Conditions for meningococcal group b vaccine

Condition Name

Condition Name for meningococcal group b vaccine
Intervention	Trials
Infections, Meningococcal	3
Meningitis, Meningococcal	2
Atopic Dermatitis	2

Condition MeSH

Condition MeSH for meningococcal group b vaccine
Intervention	Trials
Meningitis	4
Meningococcal Infections	3
Infections	3

Clinical Trial Locations for meningococcal group b vaccine

Trials by Country

Trials by Country for meningococcal group b vaccine
Location	Trials
United States	53
Poland	6
United Kingdom	5
Canada	5
France	2

Trials by US State

Trials by US State for meningococcal group b vaccine
Location	Trials
California	4
Florida	4
North Carolina	4
New York	3
Indiana	3

Clinical Trial Progress for meningococcal group b vaccine

Clinical Trial Phase

Clinical Trial Phase for meningococcal group b vaccine
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	2
Phase 3	7

Clinical Trial Status

Clinical Trial Status for meningococcal group b vaccine
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	6
RECRUITING	4

Clinical Trial Sponsors for meningococcal group b vaccine

Sponsor Name

Sponsor Name for meningococcal group b vaccine
Sponsor	Trials
GlaxoSmithKline	5
Alexion Pharmaceuticals	4
National Institute of Allergy and Infectious Diseases (NIAID)	3

Sponsor Type

Sponsor Type for meningococcal group b vaccine
Sponsor	Trials
Industry	16
Other	13
NIH	3

Meningococcal group b vaccine Market Analysis and Financial Projection

Last updated: February 8, 2026

What Is the Status of Clinical Trials for Meningococcal Group B Vaccine?

The meningococcal group B (MenB) vaccines are approved in multiple regions for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroup B. Several candidates remain in various clinical trial phases to expand indications, improve formulations, or assess new delivery methods.

Completed and Ongoing Trials

• Approved Vaccines: Bexsero (Novartis/GlaxoSmithKline) and Trumenba (Pfizer) are available globally after phase III trials demonstrating efficacy in various age groups.

• Expand Indications: Pfizer's Trumenba has completed phase IV post-marketing studies to evaluate long-term immunity and safety in adolescents and young adults.

• New Candidates: Several biotech firms, including Johnson & Johnson and Serum Institute of India, are developing novel MenB vaccines. Most are in early clinical phases (I or II), focusing on immunogenicity, safety, and dosing regimens.

Clinical Trial Numbers and Durations

Trial Phase	Number of Trials	Key Focus Areas	Estimated Completion Year
Phase I	5	Safety, dosage, immune response	2024-2026
Phase II	8	Immunogenicity, dosing schedules	2025-2027
Phase III	3	Efficacy, safety in larger populations	2026-2028

What Factors Are Influencing the Market?

• Regulatory Approvals: Regulatory bodies like the FDA and EMA have approved MenB vaccines for specific age groups. Future approvals depend on ongoing trial results, especially for expanded uses.

• Epidemiology: Countries with high meningococcal disease incidence, such as the United States, UK, and parts of Africa's meningitis belt, drive market demand.

• Vaccination Policies: Countries incorporating MenB vaccines into national immunization programs see increased demand. For example, the UK added Bexsero to routine immunizations in 2015.

• Public Perception & Uptake: Awareness campaigns and trust in safety profiles influence vaccination rates.

• Pricing & Reimbursement: Pricing strategies and insurance reimbursements significantly impact market penetration, especially in middle- and low-income countries.

How Large Is the Market Currently?

• Global Market Size: The MenB vaccine market was valued at approximately $900 million in 2022, driven by developed markets' high immunization rates.

• Market Share: Bexsero accounts for roughly 60% of the market, with Trumenba holding about 30%. Other players share smaller portions.

• Growth Rate: CAGR estimated at 8-10% from 2023 to 2030, fueled by expanding indications and emerging markets.

Region	2022 Market Size (USD millions)	Projected CAGR (2023-2030)	2030 Projection (USD millions)
North America	400	8%	730
Europe	300	9%	575
Asia-Pacific	100	11%	185
Rest of World	100	9%	180

Growth in Asia-Pacific and Latin America will be driven by increasing awareness and expanding vaccination infrastructure.

What Are Future Market Drivers and Challenges?

Drivers

• New vaccine formulations with broader strain coverage.
• Inclusion in routine childhood immunizations in emerging markets.
• Governments' initiatives to control meningococcal disease.

Challenges

• High vaccine costs hinder adoption in low-income countries.
• Limited public awareness may slow vaccination rates.
• Competitive landscape with multiple vaccine candidates in development.

What Is the Market Projection to 2030?

The market is anticipated to grow at a compound annual growth rate of approximately 9%. Key factors include:

• Broader age group vaccination, including adolescents and adults.
• Expanded licensing and approvals based on ongoing trial data.
• Increasing funding for infectious disease prevention in emerging economies.

The market could reach over $1.8 billion by 2030, assuming steady growth and the successful commercialization of new candidates.

Key Takeaways

• Two primary vaccines (Bexsero and Trumenba) are established in mature markets, with ongoing trials for expanded use.
• The global market was valued at nearly $900 million in 2022, with strong growth forecasted.
• Market expansion depends on regulatory approvals, pricing strategies, and immunization policy adoption.
• Emerging markets present significant growth potential, especially if vaccine costs decrease and immunization programs expand.
• Vaccine innovation focusing on broader strain coverage and booster duration will influence market dynamics.

FAQs

1. Are current MenB vaccines effective against all strains?
They are effective against most circulating strains but do not offer universal coverage. Strain coverage varies regionally.

2. When might new MenB vaccines gain approval?
If ongoing phase III trials demonstrate safety and efficacy, new vaccines could seek approval between 2025 and 2028.

3. What is the role of herd immunity in MenB vaccination?
It is limited due to the nature of meningococcal carriage; vaccines primarily protect vaccinated individuals.

4. How does cost impact MenB vaccine adoption?
High costs limit use in low-income countries; subsidies or tiered pricing could improve access.

5. Will MenB vaccines be included in routine immunization schedules globally?
Likely in high-incidence regions; inclusion depends on local disease burden and policy decisions.

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Sources:
[1] "Global Meningococcal Vaccines Market," MarketsandMarkets, 2023.
[2] CDC, "Meningococcal Disease," 2022.
[3] WHO, "Meningococcal Vaccine Recommendations," 2022.
[4] Pfizer, "Trumenba Clinical Trials," 2022-2023.
[5] GlaxoSmithKline, "Bexsero Development and Approvals," 2023.