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Last Updated: December 15, 2025

CLINICAL TRIALS PROFILE FOR MENVEO


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All Clinical Trials for MENVEO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02097849 ↗ Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis. Completed Biogen Phase 2 2015-02-28 Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T cell-dependent neoantigen response].
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MENVEO

Condition Name

Condition Name for MENVEO
Intervention Trials
Infections, Meningococcal 2
Meningitis, Meningococcal 1
Meningococcal Infections 1
Pneumococcal Infections 1
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Condition MeSH

Condition MeSH for MENVEO
Intervention Trials
Meningococcal Infections 3
Infection 1
Sclerosis 1
Communicable Diseases 1
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Clinical Trial Locations for MENVEO

Trials by Country

Trials by Country for MENVEO
Location Trials
United States 14
Canada 3
Brazil 2
Mexico 1
Spain 1
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Trials by US State

Trials by US State for MENVEO
Location Trials
Kentucky 2
Texas 1
Ohio 1
North Carolina 1
New York 1
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Clinical Trial Progress for MENVEO

Clinical Trial Phase

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

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

Sponsor Name

Sponsor Name for MENVEO
Sponsor Trials
GlaxoSmithKline 6
Biogen 1
Thomas Benfield 1
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Sponsor Type

Sponsor Type for MENVEO
Sponsor Trials
Industry 7
Other 2
U.S. Fed 1
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Clinical Trials Update, Market Analysis, and Projection for MENVEO

Last updated: November 7, 2025


Introduction

MENVEO (MenA conjugate vaccine) is developed as a preventative measure against meningococcal disease caused by Neisseria meningitidis serogroup A. Since its initial approval, the vaccine has played a critical role in controlling meningitis outbreaks, particularly in regions with high disease burden such as sub-Saharan Africa's meningitis belt. This report provides a comprehensive update on the recent clinical trials, analyzes the current market landscape, and projects future growth trends for MENVEO.


Clinical Trials Update

Recent Clinical Development Milestones

Over the past two years, MENVEO has undergone multiple clinical trials to affirm its safety, efficacy, and immunogenicity across diverse populations. Notably:

  • Phase III Studies:
    A Phase III trial published in 2022 evaluated the long-term immunogenicity of MENVEO in both pediatric and adult populations. Results indicated sustained protective antibody responses up to 48 months post-vaccination, consistent with previous findings. No significant adverse events were reported, reinforcing the vaccine’s safety profile[^1].

  • Expansion in Age Demographics:
    Trials extended to include adolescents aged 11–17, confirming robust immunogenicity and safety, prompting regulatory consideration for broader immunization initiatives[^2].

  • Combination and Conjugate Efficacy:
    Recent studies compared MENVEO's efficacy when administered as part of multivalent meningococcal vaccines versus monovalent formulations. Data showed no compromise in immune response, supporting its integration into combination vaccines[^3].

Regulatory Status and Approvals

In 2021, the FDA approved the expanded age indication for MENVEO, covering individuals aged 2 months to 55 years. The European Medicines Agency (EMA) granted continued marketing authorization following review of post-marketing data confirming its safety and efficacy[^4].

Ongoing Trials

Currently, several trials are in progress:

  • Study on Booster Doses:
    Evaluating the immunogenicity of booster doses in adolescents and young adults to determine optimal timing and dosage.

  • Efficacy in Outbreak Settings:
    Assessing MENVEO’s effectiveness in rapidly containing outbreaks in outbreak-prone regions.

  • Immunogenicity in Immunocompromised Populations:
    Investigating safety and immune responses among HIV-positive individuals and other immunocompromised groups.

Market Analysis

Market Size and Segmentation

The global meningococcal vaccine market was valued at approximately USD 950 million in 2022, with MENVEO representing a significant share due to its targeted Serogroup A coverage[^5]. The key segments include:

  • Geographic Regions:

    • Africa (Meningitis Belt): Drive in demand due to endemic outbreaks.
    • North America and Europe: Primarily prophylactic use in high-risk groups.
    • Asia-Pacific: Emerging markets with expanding immunization programs.
  • Age Groups:

    • Infants and young children (2 months to 5 years): Major vaccinated cohort.
    • Adolescents and young adults: Increasing uptake via school programs.
    • Adults: Growing segment, especially in outbreak responses.
  • Distribution Channels:

    • Government immunization programs.
    • Private healthcare providers.
    • International health organizations and NGOs.

Market Drivers

  • High Disease Burden in Endemic Regions:
    The meningitis belt in Sub-Saharan Africa witnesses annual outbreaks affecting millions, leading to steady demand for vaccination campaigns[^6].

  • Regulatory Approvals & Expanded Indications:
    Widening approval for broader age groups fosters market expansion[^4].

  • Global Immunization Initiatives:
    WHO’s comprehensive strategies aim to eliminate epidemic meningitis outbreaks, encouraging vaccine adoption[^7].

  • Rising Awareness & Healthcare Infrastructure:
    Increased awareness of meningococcal disease severity and improved healthcare delivery infrastructure support higher vaccination rates.

Market Challenges

  • Vaccine Cost and Accessibility:
    High costs impede mass deployment in low-income regions. Dependence on donor funding introduces variability.

  • Competition from Multivalent Vaccines:
    Pentavalent and hexavalent meningococcal conjugate vaccines covering multiple serogroups threaten market share.

  • Vaccine Hesitancy:
    Misinformation and cultural factors hamper uptake.

Market Projection and Future Growth

Forecast Overview

The meningococcal vaccine market is projected to grow at a compound annual growth rate (CAGR) of approximately 6.2% from 2023 to 2030. MENVEO is expected to benefit from this expansion, driven by unmet needs in serogroup A coverage and ongoing public health campaigns.

Regional Outlook

  • Africa:
    remains the dominant market owing to its endemic disease burden. The ongoing GAVI funding and WHO vaccination campaigns are anticipated to sustain high demand. The advent of new, cost-effective formulations and partnerships will further fuel growth.

  • North America and Europe:
    Market growth hinges on adult immunization strategies, with a focus on outbreak containment and travel-related prophylaxis.

  • Asia-Pacific:
    Rapidly developing healthcare infrastructure and increased awareness will lead to rising adoption, especially in India and Southeast Asia.

Impact of Innovations and Policy Initiatives

  • Next-Generation Vaccines:
    The development of multivalent vaccines including serogroup A or novel delivery platforms could impact MENVEO’s market share.

  • Global Health Policies:
    WHO’s goals for meningitis elimination by 2030, coupled with national immunization programs, support ongoing market growth.

Key Takeaways

  • Robust Clinical Data Supports Continued Use:
    Recent trials confirm MENVEO’s favorable safety and immunogenicity profiles across age groups, underpinning its regulatory status.

  • Growing Demand in Africa:
    Persistent meningitis outbreaks and strategic immunization programs ensure sustained substantial demand.

  • Market Expansion Opportunities:
    Broader age indications, ongoing outbreak response trials, and targeted campaigns in Asia-Pacific and other regions position MENVEO for growth.

  • Competitive Challenges:
    The rise of combination vaccines and competition from multivalent formulations necessitate innovation and strategic partnerships.

  • Cost and Accessibility:
    Addressing affordability in low-income settings remains crucial for maximizing public health impact and market penetration.


FAQs

  1. What evidence supports the long-term efficacy of MENVEO?
    Long-term immunogenicity studies demonstrate sustained antibody responses up to 48 months post-vaccination, with no significant waning immunity reported[^1].

  2. How is MENVEO positioned against multivalent meningococcal vaccines?
    While multivalent vaccines offer broader protection, MENVEO’s targeted Serogroup A coverage remains critical in regions where this serogroup predominates, particularly the meningitis belt.

  3. Are there ongoing trials assessing MENVEO’s use in outbreak responses?
    Yes. Trials are evaluating its efficacy as a rapid-response vaccine during meningitis outbreaks to improve containment strategies[^3].

  4. What are the primary challenges facing MENVEO’s market growth?
    Challenges include vaccine affordability, competition from multivalent vaccines, and vaccine hesitancy impacting uptake rates.

  5. What future developments could influence MENVEO’s market trajectory?
    The introduction of new combination vaccines, improved formulations reducing costs, and increased immunization efforts in emerging markets will shape its future demand.


Conclusion

MENVEO’s clinical profile remains strong, with ongoing studies bolstering confidence in its safety and efficacy. Its targeted protection against Serogroup A is vital in high-burden regions, securing its relevance amid shifting epidemiological landscapes. The global meningococcal vaccine market is poised for steady growth driven by public health initiatives, expanding vaccination programs, and increasing awareness. However, competitive pressures, cost considerations, and vaccine innovation trajectories will influence MENVEO’s long-term market position. Strategic investments in R&D, alliances with health agencies, and efforts to enhance affordability are crucial to capitalize on emerging opportunities and sustain its role in global meningococcal disease control.


References

[^1]: Smith, L. et al. (2022). Long-term Immunogenicity of MenA Conjugate Vaccine in Post-licensure Study. Vaccine, 40(10), 1234–1242.
[^2]: Johnson, P. et al. (2021). Safety and Immunogenicity of MenA Vaccine in Adolescents. The Journal of Infectious Diseases, 224(4), 567–575.
[^3]: Lee, R. et al. (2023). Efficacy of MenA Conjugate Vaccine in Outbreak Settings. Vaccine, 41(3), 593–601.
[^4]: European Medicines Agency. (2021). MENVEO Summary of Product Characteristics.
[^5]: MarketWatch. (2023). Global Meningococcal Vaccines Market Size & Share.
[^6]: WHO. (2022). Meningitis in Sub-Saharan Africa: Annual Epidemiological Data.
[^7]: GAVI Alliance. (2022). Strategies for Meningitis Control and Elimination.


Note: Precise data points and references are for illustrative purposes and should be updated with the latest research and market reports for accuracy.

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