CLINICAL TRIALS PROFILE FOR HIBERIX

All Clinical Trials for HIBERIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00341250 ↗	Malaria Vaccine in Children in Mali	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2006-01-19	This study will test an experimental vaccine called AMA1-C1 in children to see if it is safe and if it reduces episodes of malaria parasitemia (parasites in the blood) in children exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each year, causing from 2 million to 3 million deaths, mostly among children less than 5 in sub-Saharan Africa. It is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to the malaria parasite and widespread resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability to control malaria through these strategies. A vaccine that could reduce illness and death from malaria would be a valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine developed by the NIAID. Tests of AMA1-C1 in 87 healthy people in the United States and in Mali found no serious harmful side effects of the vaccine. Two- and three-year-old children who live in Don gu bougou or 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 two injections (shots) of either AMA1-C1 or a Haemophilus influenzae type B vaccine called Hiberix® (Registered Trademark), which is approved and used in Mali. All shots are given in the thigh muscle. Before the first shot, a small blood sample is obtained to make sure the child is well and to see if he or she has antibodies to the malaria parasite. The second shot is given 4 weeks after the first. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic 1, 2, 3, 7 and 14 days after each shot for a physical examination. Blood samples are drawn at some visits to check for side effects of the vaccine and to measure the response to it. During the rainy season after the second vaccination, subjects come to the clinic once a month for an examination. Any child who has been ill with a disease that could be malaria has a blood sample collected by fingerstick to test for malaria and to learn about the malaria parasites causing the infection. Every fourth visit a fingerstick sample is taken regardless of whether the child has been sick. If a child becomes sick at any time during the study, he or she will be brought to the clinic for examination a...

Clinical Trial Conditions for HIBERIX

Condition Name

Condition Name for HIBERIX
Intervention	Trials
Malaria	1

Condition MeSH

Condition MeSH for HIBERIX
Intervention	Trials
Malaria	1

Clinical Trial Locations for HIBERIX

Trials by Country

Trials by Country for HIBERIX
Location	Trials
Mali	1

Clinical Trial Progress for HIBERIX

Clinical Trial Phase

Clinical Trial Phase for HIBERIX
Clinical Trial Phase	Trials
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for HIBERIX
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for HIBERIX

Sponsor Name

Sponsor Name for HIBERIX
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for HIBERIX
Sponsor	Trials
NIH	1

Clinical Trials, Market Analysis, and Projections for HIBERIX

Introduction to HIBERIX

HIBERIX, manufactured by GlaxoSmithKline Biologicals, is a Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) indicated for the active immunization against invasive disease caused by Haemophilus influenzae type b in children aged 6 weeks through 4 years (prior to the fifth birthday)[4].

Clinical Trials Overview

Study Design and Participants

Clinical trials for HIBERIX involved various study designs, including randomized, controlled trials. One notable study conducted in the U.S. involved children vaccinated with HIBERIX, a U.S.-licensed monovalent Haemophilus b Conjugate Vaccine, or a combined Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate Vaccine. The study included 2,963 children vaccinated with HIBERIX at 2, 4, and 6 months of age, with a booster dose administered between 16 to 19 months of age[1].

Adverse Reactions and Safety Profile

The clinical trials revealed common solicited adverse reactions to HIBERIX, including pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness. These reactions were generally mild to moderate, with severe reactions (Grade 3) occurring in a smaller percentage of participants. For instance, pain at the injection site was reported by 49% of the subjects, with only 4% experiencing Grade 3 pain[1].

Concomitant Administration

HIBERIX was also tested for concomitant administration with other vaccines, such as INFANRIX (DTaP) and DTaP-HBV-IPV. The safety profile remained consistent, indicating that HIBERIX can be safely administered alongside these vaccines without significant increases in adverse reactions[1].

Market Analysis

Global Vaccines Market

The global vaccines market is projected to exceed $48 billion by 2025, driven by increasing demand for vaccines, advancements in vaccine technology, and rising investments in research and development. Major players like GlaxoSmithKline (GSK), Merck, and Pfizer dominate this market, with GSK leading in 2018 with a market value of over $7 billion[2].

United States Vaccines Market

In the United States, the vaccines market is expected to surpass $21 billion by 2025. This growth is fueled by the introduction of new vaccines, increasing awareness, and regulatory support. The report highlights key trends such as collaborations, mergers and acquisitions, and licensing agreements among major vaccine manufacturers[5].

HIBERIX Market Position

HIBERIX, as a part of GSK's vaccine portfolio, benefits from the company's strong market presence. While specific revenue figures for HIBERIX are not detailed, its inclusion in the broader vaccine market indicates a significant contribution to GSK's overall vaccine sales. The vaccine's approval and continued use in preventing Haemophilus influenzae type b infections support its market position[4].

Market Projections

Growth Drivers

The market for HIBERIX and other vaccines is driven by several key factors:

• Increasing Demand: Growing awareness and need for vaccination against infectious diseases.
• Technological Advancements: Improvements in vaccine development and manufacturing.
• Regulatory Support: Favorable regulatory environments that encourage vaccine development and distribution[2][5].

Challenges and Inhibitors

Despite the growth potential, the market faces challenges such as:

• Adverse Reactions: Although rare, adverse reactions can impact public perception and uptake.
• Competition: A competitive market with multiple vaccine options can affect market share.
• Regulatory Hurdles: Stringent regulatory requirements can slow down the approval process for new vaccines or vaccine formulations[2][5].

Future Outlook

The future outlook for HIBERIX remains positive, given its established safety and efficacy profile. Continued concomitant administration studies and integration into national immunization programs will likely sustain its market presence. Additionally, GSK's strong position in the global vaccines market ensures ongoing support and investment in HIBERIX and other vaccine products[4].

Key Takeaways

• Clinical Trials: HIBERIX has been extensively tested in clinical trials, demonstrating a safe and effective profile.
• Market Size: The global vaccines market, including HIBERIX, is projected to exceed $48 billion by 2025.
• Growth Drivers: Increasing demand, technological advancements, and regulatory support drive the market.
• Challenges: Adverse reactions, competition, and regulatory hurdles are key inhibitors.
• Future Outlook: HIBERIX is expected to maintain its market position due to its safety profile and GSK's market dominance.

Frequently Asked Questions (FAQs)

1. What is HIBERIX used for?

HIBERIX is used for the active immunization against invasive disease caused by Haemophilus influenzae type b in children aged 6 weeks through 4 years[4].

2. What are the common adverse reactions to HIBERIX?

Common adverse reactions include pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness[1].

3. Can HIBERIX be administered with other vaccines?

Yes, HIBERIX can be safely administered concomitantly with other vaccines such as DTaP and DTaP-HBV-IPV[1].

4. What is the projected market size for the global vaccines market by 2025?

The global vaccines market is expected to exceed $48 billion by 2025[2].

5. Who are the major players in the global vaccines market?

Major players include GlaxoSmithKline (GSK), Merck, and Pfizer, with GSK leading the market in 2018[2].

Cited Sources:

1. HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] - FDA Prescribing Information[1].
2. Global $48 Bn Vaccines Market - Industry Size, Growth, Analysis and Forecast to 2025 - ResearchAndMarkets.com[2].
3. HIV Clinical Trials Market Size Expected to Hit USD 2.42 Billion by 2034 - Biospace[3].
4. HIBERIX | FDA - FDA.gov[4].
5. United States Vaccines Market to 2025 - PR Newswire - ResearchAndMarkets.com[5].