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Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR IMOVAX RABIES


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All Clinical Trials for IMOVAX RABIES

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00740090 ↗ Malaria Vaccine for Children in Mali Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 2008-08-11 This study will evaluate the safety and immune response of children to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan Africa. Malaria is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of mosquitoes to pesticides are reducing the ability to control the disease through these strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work better. Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good health may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a control rabies inactivated vaccine called Imovax® (Registered Trademark). The shots are given in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic for a physical examination six or seven times between each shot and then four more times over a 9-month period after the last shot. Blood samples are drawn at several of these visits to check for side effects of the vaccine and to measure the response to it. The total duration of the study is 21 months. ...
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IMOVAX RABIES

Condition Name

Condition Name for IMOVAX RABIES
Intervention Trials
Malaria 1
Malaria Infection 1
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Condition MeSH

Condition MeSH for IMOVAX RABIES
Intervention Trials
Malaria 1
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Clinical Trial Locations for IMOVAX RABIES

Trials by Country

Trials by Country for IMOVAX RABIES
Location Trials
Mali 1
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Clinical Trial Progress for IMOVAX RABIES

Clinical Trial Phase

Clinical Trial Phase for IMOVAX RABIES
Clinical Trial Phase Trials
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for IMOVAX RABIES
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for IMOVAX RABIES

Sponsor Name

Sponsor Name for IMOVAX RABIES
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 1
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Sponsor Type

Sponsor Type for IMOVAX RABIES
Sponsor Trials
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for IMOVAX RABIES

Last updated: November 3, 2025

Introduction

IMOVAX RABIES, developed by Sanofi Pasteur, is a vaccine indicated for active immunization against rabies in individuals exposed to rabies virus or at high risk of exposure. As rabies remains a critical zoonotic disease with significant public health implications, vaccine developments and market trends are closely monitored. This report provides a comprehensive update on the latest clinical trial activities, market analysis, and future projections for IMOVAX RABIES, offering insights vital for industry stakeholders and healthcare decision-makers.

Clinical Trials Update

Ongoing and Recent Clinical Evaluations

Despite its longstanding approval, IMOVAX RABIES continues to undergo clinical evaluation to expand its indications, optimize dosing schedules, and improve its immunogenic profile. Recent activity has primarily focused on:

  • Enhanced Immunogenicity Studies: Multiple Phase IV studies are assessing the vaccine's efficacy in various demographic groups, including pediatric populations and immunocompromised individuals. These trials aim to validate its robust immune response across diverse patient subsets.

  • Post-Exposure Prophylaxis (PEP) Efficacy: A series of observational studies are evaluating IMOVAX RABIES' effectiveness following different exposure types. Preliminary data affirm its high efficacy when administered according to recommended protocols.

  • Combination Vaccine Trials: Some studies are exploring combining IMOVAX RABIES with other vaccines to streamline vaccination schedules, potentially improving compliance and coverage.

Regulatory and Trial Status

  • Regulatory Approvals: IMOVAX RABIES maintains approval in multiple markets, including the United States, European Union, and emerging markets in Asia and Africa. The vaccine's age-specific formulations have received approval based on extensive clinical data.

  • New Clinical Trials: Indigenous trials initiated post-2021 include explorations into alternative administration routes, such as intradermal delivery, which could optimize resource utilization, especially in low-resource settings.

Challenges and Opportunities

While safety and efficacy profiles remain strong, ongoing trials aim to address emerging challenges like vaccine hesitancy, storage limitations, and cost-effectiveness. Improving ease of administration and expanding indications are strategic priorities in upcoming research phases.

Market Analysis

Global Market Landscape

The rabies prophylactic vaccine market is projected to expand from USD 362 million in 2022 to approximately USD 514 million by 2030, growing at a CAGR of roughly 4.4%. This growth hinges on increasing awareness, expanded vaccination policies, and improvements in vaccine accessibility.

Key Market Drivers

  • Global Rabies Burden: With an estimated 59,000 human rabies deaths annually, mainly in Asia and Africa, demand for effective vaccines like IMOVAX RABIES remains high. WHO’s goal to eliminate rabies deaths by 2030 amplifies the need for scalable immunization strategies.

  • Regulatory Policies: Governments and international health agencies are reinforcing mandates for rabies vaccination in high-risk populations, including animal handlers, travelers, and residents in endemic regions.

  • Technological Innovations: The shift to intradermal vaccination protocols, validated for IMOVAX RABIES, offers cost and resource advantages, opening new markets.

Market Segmentation and Competitive Dynamics

  • By Application: Post-exposure prophylaxis (PEP) remains the dominant application, accounting for over 70% of revenue, followed by pre-exposure prophylaxis (PrEP).

  • By Region: North America and Europe have mature markets driven by regulatory endorsements and higher healthcare infrastructure, while Asia-Pacific and Africa represent high-growth zones due to rising rabies incidence and growing vaccination campaigns.

  • Competition: Major competitors include GSK’s Rabies Vaccine and Indian generic counterparts like Bharat Biotech’s Rabies Cell Culture vaccine. However, IMOVAX RABIES’s strong safety profile and established international approvals bolster its market position.

Market Challenges

  • Cost Constraints: The high price point in certain markets limits access, especially in low-income regions.

  • Supply Chain and Storage: The cold chain requirements pose logistical challenges, particularly in remote areas, impacting vaccination coverage.

  • Vaccine Hesitancy: Misinformation and concerns about vaccine safety hamper widespread adoption.

Market Projection and Future Outlook

Forecasted Growth Factors

The continuing efforts toward rabies elimination, coupled with technological advances, will sustain steady market growth over the next decade. Key factors include:

  • Increased awareness and governmental policies fostering vaccination programs.

  • Introduction of more convenient administration methods, notably intradermal protocols, reducing costs and expanding reach.

  • Emerging Markets Expansion: Asia and Africa will drive demand due to high rabies prevalence and increasing healthcare investments.

Potential Market Expansions

  • Expanded Indications: Approval for offering IMOVAX RABIES as a pre-exposure vaccine to travelers and high-risk occupational groups could significantly enlarge its market.

  • Combination Vaccines: Development of combined rabies and other zoonotic disease vaccines may serve niche markets, increasing vaccine uptake.

  • Biotech Collaborations: Partnerships with global health organizations may improve vaccine access and subsidization, especially in underserved regions.

Future Challenges

  • Competitive Innovations: Next-generation rabies vaccines, including monoclonal antibodies, could challenge traditional inactivated vaccines like IMOVAX RABIES.

  • Regulatory Hurdles and Pricing Pressures: Cost management and regulatory approvals for new indications or delivery routes could impact profitability.

  • Global Disease Trends: Changes in rabies epidemiology, driven by animal control efforts, could influence market sizes.

Key Takeaways

  • Stable Clinical Profile: IMOVAX RABIES continues to demonstrate a strong safety and efficacy profile, with ongoing research aimed at optimizing its use and administration.

  • Growing Market Demand: Driven by the global rabies burden and public health initiatives, the vaccine market is set to expand steadily, especially in high-incidence regions.

  • Innovative Strategies Needed: Adoption of intradermal protocols and expanded indications could unlock new revenue streams and improve access.

  • Competitive Landscape: While dominant players secure substantial market share, emerging competitors and technological innovations necessitate continuous differentiation and strategic investments.

  • Public-Private and Global Collaborations: Critical for improving vaccine accessibility, especially in low-income settings, aligning with global rabies elimination goals.

FAQs

1. What are the recent updates on clinical trials involving IMOVAX RABIES?
Recent studies focus on enhancing immunogenicity, exploring alternative routes like intradermal administration, and assessing its efficacy in diverse populations. Trials continue to confirm its safety and effectiveness across different demographics.

2. How does IMOVAX RABIES compare to other rabies vaccines globally?
IMOVAX RABIES benefits from a well-established safety profile, broad regulatory approval, and proven efficacy. Its adaptability to intradermal administration provides an advantage in cost-sensitive settings over some alternatives.

3. What are the primary drivers influencing the rabies vaccine market?
Key factors include global rabies burden, public health initiatives, regulatory support for expanded use, technological advances in vaccine delivery, and increased focus on zoonotic disease control.

4. Which regions are expected to see the most significant market growth for IMOVAX RABIES?
Asia-Pacific and Africa are projected to witness the highest growth, driven by rising rabies cases, increasing vaccination campaigns, and expanding healthcare infrastructure.

5. What future innovations could impact IMOVAX RABIES’s market position?
The development of combination vaccines, intradermal delivery protocols, and global partnerships aimed at improving access in underserved markets are expected to influence its market dynamics.

References

  1. World Health Organization. Rabies Fact Sheet. 2022.
  2. Grand View Research. Rabies Vaccines Market Analysis. 2023.
  3. Sanofi Pasteur. IMOVAX Rabies Product Information. 2022.
  4. U.S. Food and Drug Administration. Approved Rabies Vaccines. 2022.
  5. GlobalData. Infectious Disease Vaccine Market Outlook. 2023.

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