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

MENACTRA (MenACWY) Clinical Trials Update, Market Analysis and Projection

Last updated: May 7, 2026

What is MENACTRA and what’s the current clinical-trials posture?

MENACTRA is a meningococcal conjugate vaccine indicated for prevention of invasive disease caused by Neisseria meningitidis serogroups A, C, W and Y. It is a legacy, established product with large-scale real-world uptake and routine immunization use rather than active late-stage development programs.

Because MENACTRA’s label is for an already-approved vaccine, the most decision-relevant “clinical trials update” in this use-case is the evidence base that sustains authorization and post-authorization immunogenicity/lot performance rather than an ongoing Phase 3 efficacy program. In market terms, the product competes on schedule/coverage with other MenACWY conjugates and on procurement preferences by region and payer.

Product positioning (core competitive fact pattern)

• Scope: MenACWY prevention of invasive meningococcal disease (serogroups A, C, W, Y).
• Place in care: Routine adolescent vaccination and travel-related / risk-based vaccination in jurisdictions that use MenACWY conjugates.
• Development model: Not a “pipeline” drug; it is a commercial vaccine with ongoing manufacturing and periodic evidence updates for comparability, immunogenicity, and coverage policy compliance (how authorities and payers decide coverage).

Clinical-trials evidence that underpins continued use (summary)

• MENACTRA approval and ongoing use rest on conjugate-vaccine immunogenicity bridging and clinical trial immunogenicity endpoints (e.g., serum bactericidal activity with human complement) that correlate with protection for MenACWY.
• Publicly disclosed clinical-trial activity is often focused on:
  • lot-to-lot consistency and manufacturing changes,
  • co-administration (timing) with other vaccines used in the same age cohorts,
  • immunogenicity in target age groups (pediatric/adolescent schedules).

This is consistent with how established conjugate vaccines are maintained post-approval: the clinical “update” is typically post-authorization evidence rather than new efficacy trials.

Regulatory documentation basis

• MENACTRA’s composition and clinical evidence are defined in FDA-approved labeling and associated prescribing information. Key clinical data elements used to support immunogenicity and expected effectiveness are reflected in the label. (Source: FDA prescribing information for MENACTRA [1].)

How big is the MENACTRA addressable market and what drives demand?

MENACTRA’s market is driven by:

• Universal or near-universal adolescent immunization mandates in multiple markets.
• Catch-up vaccination and school-entry requirements.
• Travel and risk-based vaccination (college travel, outbreaks, as recommended by public health authorities).
• Procurement cycles by national immunization programs and large public-sector buyers.
• Competitive set dynamics: it competes with other MenACWY conjugates (and in some markets with broader serogroup products if substitution is allowed).

Market structure (demand segmentation that matters)

Demand is largely “immunization policy led,” not prescriber-led. The buying decision is usually determined by:

• country/state immunization schedule,
• payer coverage,
• procurement contracts and tender terms,
• supply availability and shelf-life/handling constraints.

Pricing and margin mechanics

MENACTRA behaves like a mature vaccine:

• pricing is constrained by tender competition and public-sector price regulation in many countries,
• volume is sensitive to schedule policy and substitution rules.

Competitive substitutes that affect MENACTRA projection

MENACTRA’s closest substitutes are other MenACWY conjugate vaccines sold in the same geography and schedule windows. Market outcomes depend on tender selection and whether a buyer switches formulations.

What is the clinical and commercial “go-forward” risk profile?

For an established MenACWY vaccine like MENACTRA, the principal risks are not scientific failure but schedule and procurement shifts.

Key commercial risks

• Formulary substitution in tenders: buyers switch to alternative MenACWY conjugates when price and supply align.
• Policy changes: changes in adolescent schedule, catch-up policies, or strain/outbreak response rules can shift volumes across products.
• Manufacturing capacity and supply interruptions: can cause missed procurement cycles.
• Competition from broader or newer formulations: if a jurisdiction updates recommendations to a different product class, volumes can re-allocate.

Key clinical risks

• Population immunogenicity consistency: maintained via ongoing manufacturing and comparability programs.
• Co-administration schedules: immunogenicity and safety consistency when combined with routine pediatric/adolescent vaccines.

These are label-maintenance and lifecycle risks that typically show up as minor evidence updates, not new Phase 3 endpoints.

What does the current market outlook imply for MENACTRA revenue projection?

A precise revenue projection requires either (i) disclosed company segment revenue, or (ii) market sizing studies by geography and brand. This prompt does not provide such inputs and it would be inaccurate to invent a numeric forecast.

What can be stated as actionable, decision-grade is the projection logic used by vaccine investors and commercial teams:

Projection framework (how MENACTRA volumes track)

1. Anchor demand = immunization schedules
   • adolescent cohort size multiplied by uptake and schedule coverage,
   • catch-up programs add a time-lagged volume component.
2. Tender-driven share adjustment
   • MENACTRA share fluctuates based on procurement cycles and price competitiveness versus rivals.
3. Replacement cycles
   • if buyers allow switchovers, MENACTRA faces step-down risk at contract renewals.
4. No “drug-like” durability
   • vaccines do not have patent cliff dynamics that play out the same way as small molecules, but product demand can erode when tenders prefer other conjugates.

Practical projection takeaways (directional)

• Base demand should remain stable-to-moderately declining in mature markets if tender competition increases and if share drifts to lower-cost alternatives.
• Growth depends on expansion of universal vaccination policies and catch-up acceleration in markets that still adopt adolescent MenACWY programs at scale.
• Short-term volatility should track procurement timing and supply continuity, not clinical development outcomes.

How is MENACTRA positioned versus other meningococcal conjugates?

MENACTRA competes in a crowded but policy-anchored category. Buyers optimize for:

• tender cost per dose delivered,
• storage and logistics,
• availability and lead times,
• documented immunogenicity performance in target age cohorts.

The product’s advantage is continued authorization and established trust in routine adolescent use, while competitive pressure concentrates on procurement price and contract allocation.

What should decision-makers monitor over the next procurement cycle?

For an investor or R&D business unit, the highest signal items are:

• Tender outcomes in key markets: whether MENACTRA is retained or replaced at contract renewal.
• Schedule updates: changes in recommended age of first dose, catch-up guidance, and booster timing if any jurisdiction revises guidance.
• Supply continuity: any disruptions that cause missed allocations or forced substitutions.
• Label-adjacent evidence updates: co-administration and immunogenicity evidence that could affect local policy acceptance.

Key Takeaways

• MENACTRA is a mature MenACWY conjugate vaccine with clinical support primarily maintained through immunogenicity, comparability, and co-administration evidence rather than an ongoing late-stage efficacy trial program. (Source: FDA labeling [1].)
• Demand is driven by immunization policy and procurement cycles, not pipeline breakthroughs. The dominant commercial swing factor is tender share versus competing MenACWY conjugates.
• A credible revenue projection must be built from cohort-driven vaccination demand plus tender share scenarios. In the absence of market sizing or contract data, only a directional outlook is appropriate: stable baseline in mature policy jurisdictions with share-dependent variation.

FAQs

1) Is MENACTRA currently in Phase 3 clinical trials?

MENACTRA is an approved vaccine; the evidence supporting ongoing use is reflected in regulatory labeling and lifecycle evidence rather than a current Phase 3 efficacy program in the public record for this question set. (Source: FDA prescribing information [1].)

2) What endpoints matter most for MenACWY vaccines like MENACTRA?

Regulators and labels use immunogenicity measures such as serum bactericidal activity (human complement) as key correlates for conjugate vaccines. (Source: FDA prescribing information [1].)

3) What drives MENACTRA sales volume month to month?

Public procurement cycles, tender award timing, uptake under school-entry and adolescent schedules, and supply availability are the key drivers.

4) What category competitors most affect MENACTRA market share?

Other MenACWY conjugate vaccines offered for the same adolescent and catch-up schedules in the same geographies.

5) What is the highest-risk event for MENACTRA in the next year?

Loss of tender share at contract renewals or schedule changes that re-allocate immunization volumes to alternative formulations.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). MENACTRA (meningococcal conjugate vaccine) prescribing information. https://www.accessdata.fda.gov/ (See MENACTRA label/PI entry for dosing, indications, and clinical immunogenicity evidence.)