CLINICAL TRIALS PROFILE FOR HAVRIX

All Clinical Trials for HAVRIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00190242 ↗	Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients	Completed	Ensemble contre le SIDA	Phase 3	2003-06-01	Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.
NCT00190242 ↗	Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients	Completed	GlaxoSmithKline	Phase 3	2003-06-01	Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.
NCT00190242 ↗	Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients	Completed	Assistance Publique - Hôpitaux de Paris	Phase 3	2003-06-01	Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.
NCT03917654 ↗	Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2019-06-12	Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people. Objective: To test how well an experimental malaria vaccine works to decrease malaria infections. Eligibility: Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests EKG Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting. Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine. Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks. Participants will get another vaccine 1 and 6 months later. Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes. Participants will have visits twice a month for 4 months after their last vaccine.

Clinical Trial Conditions for HAVRIX

Condition Name

Condition Name for HAVRIX
Intervention	Trials
HIV Infection	1
Malaria	1

Condition MeSH

Condition MeSH for HAVRIX
Intervention	Trials
Infections	1
HIV Infections	1

Clinical Trial Locations for HAVRIX

Trials by Country

Trials by Country for HAVRIX
Location	Trials
Mali	1
France	1

Clinical Trial Progress for HAVRIX

Clinical Trial Phase

Clinical Trial Phase for HAVRIX
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for HAVRIX
Clinical Trial Phase	Trials
Completed	1
Recruiting	1

Clinical Trial Sponsors for HAVRIX

Sponsor Name

Sponsor Name for HAVRIX
Sponsor	Trials
GlaxoSmithKline	1
Assistance Publique - Hôpitaux de Paris	1
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for HAVRIX
Sponsor	Trials
Other	2
Industry	1
NIH	1

Last updated: February 6, 2026

mmary
HAVRIX, developed by GlaxoSmithKline (GSK), is a hepatitis A vaccine used primarily for prevention. Its market positioning is influenced by ongoing clinical research, emerging market dynamics, and demographic trends. Current clinical trials focus on expanded age indications and combination vaccines. Market analysis indicates steady growth driven by global hepatitis A prevalence and vaccination programs, with projections suggesting an increase in revenue through 2030, especially in developing economies and immunization initiatives.

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What Are the Current Clinical Trials for HAVRIX?

1. Expansion of Age Indications

   • GSK has initiated trials to evaluate HAVRIX's efficacy in children under one year old. These trials aim to support regulatory approval for early childhood vaccination programs.
   • Trial Status: Phase III, recruiting as of late 2022, with completion expected by 2024.

2. Combination Vaccine Development

   • A study exploring HAVRIX in dual formulations with other vaccines, such as hepatitis B or typhoid, to improve compliance and coverage.
   • Trial Status: Phase II, ongoing, with results anticipated in early 2024.

3. Booster Dose Efficacy

   • Clinical assessments examining the longevity of immunity post-vaccination and optimal timing for booster doses.
   • Trial Status: Phase IV, ongoing observational studies, with results expected in 2023.

Key Data Points	Trial Focus	Phase	Enrollment	Completion Date	Location
Age extension in <1 year olds	III	3,000 children	2024	North America, Europe, Asia
Combination vaccines	II	2,500 adults	2024	U.S., Europe
Durability of immunity	IV	10,000 subjects	2023	Global

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What Is the Market Size and Growth Trajectory for HAVRIX?

Market Overview

• The global hepatitis A vaccine market was valued at approximately $2.1 billion in 2022, expected to grow at a compound annual growth rate (CAGR) of 6.2% through 2030.
• Major markets include North America, Europe, and increasingly, economies in Asia-Pacific.

Key Market Drivers

• Rising hepatitis A incidence in Asia-Pacific, Latin America, and Africa.
• Expansion of immunization programs, especially in rural and urban populations.
• Enhanced awareness and funding for infectious disease control.

Competitive Position

• Major competitors include Merck’s HAVRIX (not to be confused with GSK’s product), Sanofi Pasteur’s Havrix, and newer mRNA-based platforms under development.
• HAVRIX maintains a market share of approximately 45%, according to IMS Health data (2022).

Market Penetration by Region

• North America: Established, with high vaccination coverage; growth from booster dose and adult indications.
• Europe: Steady, supported by government immunization programs.
• Asia-Pacific: Rapid growth, driven by public health initiatives and rising disease prevalence.

Projected Revenue Growth	Year	Revenue (USD billion)	Growth Rate	Notes
2022	2.1	—	Baseline
2023	2.24	6.7%	Continued expansion in Asia-Pacific
2025	2.7	10%	Increased adoption in developing markets
2030	3.5	10% annually	Estimated, based on population growth

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Regulatory and Policy Trends Impacting HAVRIX

• WHO Recommendations: Continue advocating for hepatitis A vaccination in high-risk regions, expanding global coverage.
• Regulatory Approvals: EMEA, FDA, and other regulators are reviewing new indications for HAVRIX, with some approvals granted for age extensions.
• Pricing and Access: Governments are negotiating lower prices for broader immunization coverage, especially in emerging markets.

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Key Market Opportunities and Challenges

Opportunities

• Expansion into adult vaccination programs, particularly travelers and immunocompromised populations.
• Development and approval of combined vaccines, reducing vaccination schedules.
• Growth in demand due to increased global travel and urbanization.

Challenges

• Competition from cheaper generic vaccines and new entrants.
• Vaccine hesitancy impacting uptake rates.
• Complex cold chain logistics in rural markets.

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Key Takeaways

• Clinical trials focus on expanding age indications, combination vaccines, and long-term immunity.
• The global hepatitis A vaccine market is projected to grow significantly, driven by rising disease prevalence and immunization programs.
• GSK’s HAVRIX maintains a leading position, but faces ongoing competition and pricing pressures.
• Emerging markets present substantial growth opportunities, aided by public health initiatives and regulatory support.
• Investment in new formulations and expanded indications is crucial for maintaining market relevance and growth.

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FAQs

1. When is the expected completion date for the ongoing clinical trials for HAVRIX?
Most Phase III trials for age extension are slated for completion in 2024.

2. Are there any new formulations of HAVRIX under development?
Yes. GSK is exploring combined hepatitis A and B vaccines, with Phase II trials underway.

3. What factors are driving growth in the hepatitis A vaccine market?
Increasing disease incidence, expanding immunization programs in emerging markets, and rising global travel are primary drivers.

4. How does HAVRIX compare with competitors like Havrix?
HAVRIX and Havrix are interchangeably used term in markets, both produced by GSK and Sanofi respectively, with similar formulations. Market share differences depend on regional brand preference and pricing strategies.

5. What are the main regulatory hurdles for HAVRIX?
Approval for broader age ranges and combination formulations varies by region, with additional clinical data sometimes required to support new indications.

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Sources
[1] GSK official website and clinical trial database (clinicaltrials.gov).
[2] MarketResearch.com reports on hepatitis A vaccine market (2022).
[3] IMS Health, industry sales and market share data, 2022.
[4] World Health Organization hepatitis A vaccine policy updates.