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
Ensemble contre le SIDA	1
GlaxoSmithKline	1
Assistance Publique - Hôpitaux de Paris	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for HAVRIX

Last updated: November 7, 2025

Introduction

HAVRIX, developed by GlaxoSmithKline (GSK), is an established hepatitis A vaccine widely used to prevent hepatitis A virus (HAV) infections. Given its long-standing presence in vaccination programs globally, recent developments, clinical trial updates, and market dynamics are critical for stakeholders. This report provides a comprehensive analysis of the current clinical advances, market trends, and future projections concerning HAVRIX.

---

Clinical Trials Update for HAVRIX

Ongoing and Recent Clinical Trials

Despite HAVRIX's extensive history of proven efficacy and safety, ongoing clinical trials aim to enhance its formulation and expand its indications. Recent trial activities focus on:

• Enhanced Immunogenicity in Vulnerable Populations: Trials investigate improved doses or adjuvanted formulations to boost immune response among immunocompromised groups, such as HIV-positive individuals and the elderly. For instance, a 2022 clinical trial evaluated a higher-dose regimen in immunosuppressed adults, aiming to extend protection duration (ClinicalTrials.gov ID: NCT04801902).

• Combination Vaccines: Researchers assess the potential of HAVRIX in combination with other vaccines, particularly against hepatitis B and typhoid, to improve compliance and coverage in endemic regions. A notable trial (NCT04952324) tested a pentavalent vaccine containing HAV components, with preliminary results indicating promising immunogenicity profiles.

• Durability and Booster Efficacy: New studies track antibody titers over extended periods post-vaccination, assessing the necessity and timing for booster doses. A 2022 longitudinal study followed vaccinated individuals for five years, indicating sustained immunity (published in Vaccine Journal).

Regulatory and Safety Monitoring

Regulatory agencies, including the FDA and EMA, continue to monitor HAVRIX’s safety profile, with no recent major safety concerns reported. Ongoing pharmacovigilance ensures that emerging data are integrated into current labeling and recommendations.

---

Market Analysis of HAVRIX

Market Dynamics and Key Drivers

HAVRIX's global market remains robust due to several factors:

• Universal Hepatitis A Vaccination Policies: Many governments, especially in developing and middle-income countries, include HAVRIX in their routine immunization schedules. The WHO recommends hepatitis A vaccination in endemic areas, boosting demand.

• Emergency and Travel Immunization: Increasing international travel and rising awareness about hepatitis A contribute to steady demand for the vaccine as a pre-travel prophylactic.

• COVID-19 Pandemic Impact: The pandemic disrupted routine vaccination campaigns temporarily, but recovery is underway, with catch-up campaigns and increased emphasis on infectious disease prevention reaffirming vaccine importance.

Competitive Landscape

HAVRIX faces competition primarily from vaccines like VAQTA (Merck), Havrix (GSK’s branded product globally), and other regional products. The competitive edge of HAVRIX lies in its extensive global approval, proven efficacy, and longstanding manufacturer reputation.

Market Share and Revenue Trends

GSK maintained a significant share of the hepatitis A vaccine market, with global revenues estimated to be around $200 million annually pre-pandemic. The post-pandemic environment and institutional vaccinations influence future revenues.

Regional Market Analysis

• Developing Countries: High demand remains due to endemic hepatitis A; however, infrastructure challenges affect distribution.

• Developed Markets: Emphasis on adult vaccinations and travel medicine sustains steady sales, with an increasing focus on preventing outbreaks among specific populations, such as MSM communities.

---

Future Market Projections

Growth Outlook (2023-2030)

The hepatitis A vaccine market, including HAVRIX, is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6%, driven by:

• Expansion into New Demographics: The inclusion of hepatitis A vaccination in adult immunization schedules, especially during outbreak responses and travel vaccination pushes, is expected to expand usage.

• Innovation in Formulation: Development of thermostable formulations and combination vaccines, as seen in recent trials, will likely catalyze market expansion.

• Emerging Markets Adoption: Increasing healthcare infrastructure investment in Asia-Pacific, Africa, and Latin America will facilitate broader HAVRIX uptake.

Challenges and Opportunities

• Vaccine Hesitancy: Misinformation and vaccine skepticism could hinder uptake, necessitating educational campaigns.

• Supply Chain Constraints: Ensuring global manufacturing capacity meets demand, especially in endemic regions, will be critical.

• Regulatory Approvals: Accelerated approvals or expanded indications in emerging markets could provide growth opportunities.

Strategic Recommendations

GSK and stakeholders should focus on:

• Advancing formulations suitable for broader age groups and immunocompromised populations.
• Strengthening distribution channels in underserved regions.
• Promoting post-market surveillance to demonstrate ongoing safety and efficacy.

---

Key Takeaways

• Clinical Development: Ongoing trials aim to improve HAVRIX's immunogenicity and expand its use in combination vaccinations, reinforcing its role in disease prevention.

• Market Positioning: HAVRIX maintains a strong presence in global hepatitis A vaccination programs, supported by regulatory approvals and longstanding efficacy data.

• Growth Potential: The market is expected to grow steadily, driven by emerging market adoption, innovation in vaccine formulations, and increased awareness of hepatitis A risks.

• Challenges: Supply chain logistics, vaccine hesitancy, and regulatory hurdles could temper growth; strategic efforts are essential to mitigate these risks.

• Opportunities: Broader indications, combination vaccines, and targeted campaigns in high-risk populations present significant avenues for expansion.

---

FAQs

1. What are the recent advancements in HAVRIX formulations?
Recent clinical trials focus on developing thermostable formulations and higher-dose regimens targeting immunocompromised populations, aiming to prolong protection and improve efficacy.

2. How does HAVRIX compare with other hepatitis A vaccines?
HAVRIX is comparable to other vaccines like VAQTA in efficacy and safety. Its established global approval and extensive manufacturing capacity give it a competitive edge in distribution, especially in developing economies.

3. Are there upcoming indications or approvals for HAVRIX?
While current indications primarily revolve around prophylactic use in travelers and endemic areas, ongoing trials exploring combination vaccines and broader age group approvals could expand its indications.

4. What is the impact of COVID-19 on HAVRIX’s market?
The pandemic disrupted vaccination programs but also spurred interest in infectious disease prevention. Recovery efforts and catch-up campaigns are expected to stabilize and gradually boost HAVRIX demand.

5. What strategic moves should manufacturers consider to maximize HAVRIX’s market?
Investment in formulation innovation, expanding supply chains, targeted marketing in emerging markets, and participation in emerging clinical trials are key strategies to sustain growth.

---

References

[1] ClinicalTrials.gov. HAVRIX-related studies. 2022-2023.
[2] GSK Annual Reports and Market Data. 2022.
[3] World Health Organization. Hepatitis A vaccine guidelines and recommendations. 2021.
[4] MarketResearch.com. Global hepatitis A vaccine market forecasts. 2023.
[5] Vaccine Journal. Long-term immunity post-hepatitis A vaccination. 2022.