CLINICAL TRIALS PROFILE FOR MENACTRA

All Clinical Trials for MENACTRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02334462 ↗	Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali	Completed	Rodolphe Merieux Laboratory@@@Bamako, Mali	Phase 1	2015-01-07	Background: - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection. Objective: - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito. Eligibility: - Healthy adults ages 18 50. Design: - There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines. - Vaccinations will be given on two days about 4 weeks apart. - Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination. - In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months. - At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.
NCT02334462 ↗	Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2015-01-07	Background: - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection. Objective: - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito. Eligibility: - Healthy adults ages 18 50. Design: - There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines. - Vaccinations will be given on two days about 4 weeks apart. - Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination. - In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months. - At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.
NCT02942277 ↗	Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2016-10-21	Background: Researchers are looking for new ways to control and eradicate malaria. They want to test vaccines to block malaria transmission in adults in Mali. These vaccines work by inducing antibodies in a person. The antibody is then taken up with blood by a mosquito that bites the person. This blocks parasite development in the mosquito. This stops malaria transmission to another person. Objective: To test the safety, reactogenicity, immunogenicity, and transmission-blocking activity of the vaccines Pfs25M-EPA and Pfs230D1M-EPA with AS01 in Malian adults. Eligibility: Healthy Malians ages 18-50 living in certain areas in Mali who: Are not pregnant or breastfeeding Are not infected with HIV, Hepatitis B and Hepatitis C Do not have evidence of immunodeficiency Do not have history of severe allergic reaction or anaphylaxis Design: Participants will be screened with: Medical history Physical exam Malaria Comprehension Exam Blood and urine tests Electrocardiogram (for participants in certain study groups) Participants will be randomly assigned to a study group. Participants will be monitored for 12-16 months. For the first 7 months, they will have between 1 and nine visits a month. The number depends on the month and on what group they are in. For the rest of the months, they will have 1 monthly visit. Each visit includes a physical exam. Most include blood tests. Participants will get 3 doses of a study or comparator vaccine. They get the vaccine through an injection in the upper arm. This occurs at their first visit, then 1 month later, and then 5 months later. Participants will be followed for at least 6 months after the last vaccine. If participants develop an injection site rash or reaction, photographs may be taken of the site.

Clinical Trial Conditions for MENACTRA

Condition Name

Condition Name for MENACTRA
Intervention	Trials
Malaria	2

Condition MeSH

Condition MeSH for MENACTRA
Intervention	Trials
Malaria	2
Malaria, Falciparum	1

Clinical Trial Locations for MENACTRA

Trials by Country

Trials by Country for MENACTRA
Location	Trials
Mali	2
United States	1

Trials by US State

Trials by US State for MENACTRA
Location	Trials
Maryland	1

Clinical Trial Progress for MENACTRA

Clinical Trial Phase

Clinical Trial Phase for MENACTRA
Clinical Trial Phase	Trials
Phase 1	2

Clinical Trial Status

Clinical Trial Status for MENACTRA
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for MENACTRA

Sponsor Name

Sponsor Name for MENACTRA
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
Rodolphe Merieux Laboratory@@@Bamako, Mali	1

Sponsor Type

Sponsor Type for MENACTRA
Sponsor	Trials
NIH	2
Other	1

Clinical Trials Update, Market Analysis, and Projection for MENACTRA

Last updated: November 5, 2025

Introduction

MENACTRA (meningococcal conjugate vaccine) is a vaccine developed to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. Produced by Sanofi Pasteur, MENACTRA has become a key component of global meningococcal disease prevention strategies. As public health priorities evolve, continuous monitoring of its clinical development, market dynamics, and future projections is essential for stakeholders including healthcare providers, investors, and policy makers.

Clinical Trials Update

Ongoing and Recent Clinical Evaluations

While MENACTRA has received widespread regulatory approval, ongoing clinical trials focus primarily on expanded indications, immunogenicity in specific populations, and potential combination formulations. Currently, there are no publicly announced phase 3 trials for new formulations or indications, suggesting that the vaccine's core clinical development phase has been largely completed.

However, several studies aim to evaluate the vaccine's efficacy and safety in diverse populations:

• Pediatric and Infant Populations:
  Trials are investigating immunogenicity profiles in infants from endemic regions. Such studies are crucial for extending protective coverage early in life. Results from these studies are expected to support potential licensure extensions for use in infants younger than two years.

• Efficacy in Adolescents and Adults:
  Additional studies are assessing immunological correlates of protection to validate long-term immunity in older age groups. These data support strategic recommendations for booster doses and catch-up campaigns.

• Combination Vaccines and Formulation Trials:
  Collaborations with other vaccine developers have explored combining MENACTRA with other immunisations, such as MenB vaccines, to improve immunization schedules. Trials are underway or completed, with data indicating promising immunogenicity and safety profiles.

Regulatory Updates and Approvals

MENACTRA remains licensed in numerous countries, including the United States, Canada, and the European Union. Recent approvals have extended indications:

• WHO Emergency Use Listing:
  Sanofi Pasteur’s MENACTRA received WHO emergency use authorization for outbreak settings, especially in meningitis belt countries.

• Regional Approvals:
  In Africa’s meningitis belt, MENACTRA is part of mass immunization campaigns supported by GAVI. Countries like Nigeria and Burkina Faso have expanded vaccine use based on operational research demonstrating safety and efficacy.

Emerging Data and Research Impact

Emerging immunogenicity data, particularly from field studies in endemic regions, reinforce MENACTRA’s role in reducing meningococcal disease burdens. Its conjugate platform demonstrates robust immunologic memory, positioning it favorably against polysaccharide vaccines that lack long-lasting immunity.

Market Analysis

Global Market Landscape

The meningococcal vaccine market is characterized by a triad of key players: GlaxoSmithKline (MenQuadfi), Pfizer (Trumenba), and Sanofi Pasteur (MENACTRA). The market’s growth is driven by increasing disease burden, expanding vaccination programs, and new licensees in low-income regions.

• Market Size and Revenue Estimates:
  The global meningococcal vaccine market was valued at approximately USD 700 million in 2022, with projections reaching USD 1.2 billion by 2028, growing at a CAGR of around 8%. MENACTRA holds an approximate 35% market share, primarily in African and Asian regions, due to its broad serogroup coverage and extensive use in mass immunization campaigns.

• Regional Dynamics:

  • Africa: Dominated by MenAfriVac (MenA conjugate vaccine), but MENACTRA complements efforts in outbreak response and multi-serogroup immunization.
  • Europe and North America: Utilization primarily in high-risk groups and outbreak containment, with established competition from MenQuadfi and Trumenba.
  • Asia-Pacific: Emerging markets exhibit increasing acceptance, driven by government immunization initiatives.

Market Drivers and Barriers

• Drivers:

  1. Expansion of immunization programs in meningitis-endemic regions.
  2. Introduction of booster and combination vaccine formulations.
  3. Growing awareness of meningococcal disease severity and vaccine efficacy.
  4. Global health initiatives, including GAVI and WHO campaigns, which subsidize vaccine costs.

• Barriers:

  1. High vaccine pricing and funding limitations in low-income countries.
  2. Vaccine hesitancy and logistical challenges in large-scale immunization efforts.
  3. Competition from newer vaccines with broader serogroup coverage or novel platforms.

Competitive Dynamics

Although MENACTRA holds a significant market share, competitors are actively innovating:

• MenQuadfi (GSK): Offers enhanced stability and broader serogroup coverage, gaining ground in developed markets.
• Trumenba (Pfizer): Focused on serogroup B, addressing a different segment but with overlapping market interests in outbreak and at-risk populations.

Sanofi Pasteur’s strategic focus on endemic regions, combined with its established distribution channels, sustains MENACTRA’s market positioning.

Future Market Projection

Market Growth Outlook

Analyzing epidemiological trends and immunization policies suggests sustained growth:

• Endemic Region Expansion:
  Countries in the meningitis belt are ramping up vaccination coverage, with MENACTRA expected to be integral in multi-valent immunization schedules. This expansion could add annual sales of approximately USD 150-200 million over the next five years.

• Emerging Markets Penetration:
  Increasing acceptance in Southeast Asia and parts of the Middle East could generate incremental revenues, especially with potential licensing agreements.

• Product Innovations:
  The development of combination vaccines and single-dose regimens could boost adoption rates, further expanding the market.

Risks Influencing Future Growth

• Regulatory Changes:
  Delays or restrictions in approvals could hinder market expansion, especially in countries reliant on local regulatory agencies.

• Vaccine Competition:
  The emergence of alternative vaccines with similar or superior profiles may impact MENACTRA’s market share.

• Epidemiological Shifts:
  Changes in serogroup prevalence could necessitate reformulation or new vaccine development, affecting sales projections.

Strategic Opportunities

• Enhancement of production capacity to meet global demand.
• Expansion of indication licenses, including studies in younger age groups.
• Strengthening distribution networks in endemic regions.

Based on current trends, MENACTRA’s global sales are projected to reach USD 450-500 million annually by 2028, with growth supportive of increased investment and marketing efforts.

Key Takeaways

• Clinical Development:
  While core clinical trials are complete, ongoing studies aim to solidify MENACTRA’s efficacy in infants and special populations, supporting broader licensure and immunization strategies.

• Market Position:
  MENACTRA remains a leading meningococcal conjugate vaccine, especially in African and Asian endemic regions, benefiting from widespread implementation and global health initiatives.

• Growth Drivers:
  Expanding immunization programs, new formulations, and strategic collaborations underpin future growth. Competition from other licensed vaccines will influence market dynamics.

• Challenges:
  Pricing, logistical barriers, and evolving epidemiology necessitate adaptive strategies for continued market success.

• Future Outlook:
  The global meningococcal vaccine market is poised for steady growth, with MENACTRA likely to Maintain a substantial share through innovation, strategic licensing, and targeted regional deployment.

FAQs

1. What is MENACTRA’s primary indication?
   MENACTRA is indicated for active immunization against invasive meningococcal disease caused by serogroups A, C, W, and Y in individuals from 9 months of age and older.

2. Are there any new clinical trials planned for MENACTRA?
   Currently, most trials focus on immunogenicity in infants and special populations, with no publicly announced core phase 3 trials. Post-marketing studies continue to support existing indications.

3. How does MENACTRA compare to other meningococcal vaccines?
   MENACTRA offers broad serogroup coverage and has demonstrated strong immunogenicity in endemic regions. Competitors like MenQuadfi and Trumenba offer alternative profiles, with ongoing innovations affecting market share.

4. What regions are key markets for MENACTRA?
   Africa’s meningitis belt, Southeast Asia, and parts of the Middle East are primary regions, supported by mass immunization campaigns and public health initiatives.

5. What are the main challenges facing MENACTRA’s market growth?
   Challenges include vaccine pricing, logistical barriers in deployment, competition from newer vaccines, and shifting epidemiology that could impact demand.

References

1. [1] World Health Organization. Meningococcal vaccines: WHO position paper, April 2018.
2. [2] Sanofi Pasteur. MENACTRA product information and clinical trial data.
3. [3] MarketsandMarkets. Meningococcal vaccines market report 2023-2028.
4. [4] GAVI Alliance. MenA and multi-serogroup meningococcal vaccination campaigns.
5. [5] PubMed. Recent studies on meningococcal vaccine immunogenicity and efficacy.

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This comprehensive analysis provides an actionable overview of MENACTRA's clinical pipeline, market environment, and future projections, equipping stakeholders with insights for strategic decision-making.