CLINICAL TRIALS PROFILE FOR MENVEO

All Clinical Trials for MENVEO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04707391 ↗	Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine	Not yet recruiting	GlaxoSmithKline	Phase 3	2021-01-18	The purpose of this study is to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine
NCT04502693 ↗	Study to Assess Effectiveness of GlaxoSmithKline's (GSK's) Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults.	Not yet recruiting	GlaxoSmithKline	Phase 3	2020-08-14	The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety will also be evaluated in the study.
NCT04318548 ↗	Study to Assess the Immunogenicity and Safety of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age	Not yet recruiting	GlaxoSmithKline	Phase 3	2020-05-04	The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
NCT03636906 ↗	Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV	Completed	GlaxoSmithKline	Phase 1	2019-04-08	The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV, and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.
NCT02097849 ↗	Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.	Completed	Biogen	Phase 2	2015-02-28	Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T cell-dependent neoantigen response].

Clinical Trial Conditions for MENVEO

Condition Name

Condition Name for MENVEO
Intervention	Trials
Infections, Meningococcal	2
Hiv	1
Meningitis, Meningococcal	1
Meningococcal Infections	1

Condition MeSH

Condition MeSH for MENVEO
Intervention	Trials
Meningococcal Infections	3
Salmonella Infections	1
Meningitis	1
Diarrhea	1

Clinical Trial Locations for MENVEO

Trials by Country

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−

Trials by Country for MENVEO
Location	Trials
United States	14
Canada	3
Brazil	2
Italy	1
Belgium	1

Trials by US State

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−

Trials by US State for MENVEO
Location	Trials
Kentucky	2
Maryland	1
Idaho	1
Georgia	1
Texas	1

Clinical Trial Progress for MENVEO

Clinical Trial Phase

Clinical Trial Phase for MENVEO
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for MENVEO
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	2
Completed	2

Clinical Trial Sponsors for MENVEO

Sponsor Name

Sponsor Name for MENVEO
Sponsor	Trials
GlaxoSmithKline	6
Thomas Benfield	1
Biomedical Advanced Research and Development Authority	1

Sponsor Type

Sponsor Type for MENVEO
Sponsor	Trials
Industry	7
Other	2
U.S. Fed	1

MENVEO: Clinical Trials, Market Analysis, and Projections

Clinical Trials Overview

Safety and Efficacy Studies

MENVEO, a quadrivalent meningococcal conjugate vaccine, has undergone extensive clinical trials to evaluate its safety and efficacy. These trials involved a significant number of participants across various age groups and geographical locations.

• In five randomized controlled clinical trials, 6,185 participants received MENVEO alone, concomitantly with other vaccines, or a comparator vaccine. These trials were conducted in North America, Latin America, and Europe, and they included evaluations of MENVEO's safety and immunogenicity when administered with other vaccines such as Tdap and HPV[1].
• Additional studies focused on the one-vial presentation of MENVEO, involving 1,337 subjects aged 10 through 44 years. These trials were conducted in multiple countries including Australia, Canada, Germany, and several others, comparing the one-vial presentation to the two-vial presentation[1][4].

Booster Dose Studies

Clinical trials also examined the safety and efficacy of booster doses of MENVEO. A multicenter, open-label clinical trial in the US involved 601 subjects aged 15 through 51 years who received a single booster dose of MENVEO 4 to 6 years after prior vaccination. This study found similar rates of solicited adverse reactions compared to primary vaccination, with common reactions including pain at the injection site and fatigue[4].

Market Analysis

Market Size and Growth

The global meningococcal vaccines market, which includes MENVEO, was valued at USD 3.28 billion in 2022 and is projected to grow at a CAGR of 6.0% from 2023 to 2030. This growth is driven by increasing initiatives by government and regulatory authorities to combat the rising prevalence of meningitis[5].

Segment Dominance

Quadrivalent vaccines, such as MENVEO, Menactra, and Nimenrix, dominated the market with a 51.1% revenue share in 2022. This dominance is due to their ability to target four serogroups (A, C, W, and Y) and their widespread use[2][5].

Age Group Segmentation

The infants (0-2 years) segment is expected to be the fastest-growing segment over the forecast period, driven by the increasing prevalence of meningitis in this age group. However, MENVEO is primarily used in adolescents and adults, where it has shown strong market presence[2].

Geographical Distribution

The Asia Pacific region is expected to witness the highest CAGR over the forecast period, driven by high unmet needs, rising healthcare expenditure, and a large population base. MENVEO is available in over 60 countries, including those in this region, contributing to its global market share[2].

Market Projections

Sales and Revenue

Sales of MENVEO have been steadily increasing. For instance, in 2023, sales of MENVEO increased by 12% to £380 million. This growth is expected to continue as the market recovers from the impact of the COVID-19 pandemic[3].

Competitive Landscape

MENVEO competes with other quadrivalent vaccines such as Menactra and Nimenrix, as well as serotype B vaccines like Trumenba and Bexsero. The introduction of pentavalent vaccines, such as GSK-3536819 and Pfizer's PENBRAYA, is expected to impact the market dynamics. However, the simplified dosing schedule of these new vaccines is viewed favorably by physicians, suggesting there will be room for both products in the market[3].

Future Trends

The market is expected to grow due to increasing research activities to develop more comprehensive vaccines, including pentavalent options. The approval of new vaccines, such as Sanofi's MenQuadfi, further fuels the growth of the meningococcal vaccines market. Government initiatives to include these vaccines in immunization programs also contribute to the market's expansion[5].

Key Takeaways

• MENVEO has been extensively tested in clinical trials to ensure its safety and efficacy across various age groups and geographical locations.
• The global meningococcal vaccines market is projected to grow at a CAGR of 6.0% from 2023 to 2030, driven by increasing government initiatives and rising healthcare expenditure.
• Quadrivalent vaccines like MENVEO dominate the market due to their broad coverage against four serogroups.
• The Asia Pacific region is expected to witness the highest growth rate due to high unmet needs and a large population base.
• The introduction of pentavalent vaccines is expected to impact market dynamics but will likely coexist with existing quadrivalent vaccines.

FAQs

What are the key clinical trials that have evaluated MENVEO?

MENVEO has been evaluated in five randomized controlled clinical trials involving over 6,000 participants, as well as additional studies on its one-vial presentation and booster doses[1][4].

How does MENVEO perform in the global meningococcal vaccines market?

MENVEO is a leading quadrivalent vaccine, contributing significantly to the market share of this segment, which accounted for 51.1% of the revenue in 2022[2][5].

What is the projected growth rate of the global meningococcal vaccines market?

The global meningococcal vaccines market is projected to grow at a CAGR of 6.0% from 2023 to 2030[2][5].

How does the introduction of pentavalent vaccines impact MENVEO?

The introduction of pentavalent vaccines like GSK-3536819 and Pfizer's PENBRAYA is expected to impact the market, but these new vaccines are likely to coexist with MENVEO due to their favorable dosing schedules and the existing market presence of MENVEO[3].

Which region is expected to witness the highest growth in the meningococcal vaccines market?

The Asia Pacific region is expected to witness the highest CAGR over the forecast period due to high unmet needs, rising healthcare expenditure, and a large population base[2].

What are the common adverse reactions associated with MENVEO?

Common adverse reactions to MENVEO include pain at the injection site and fatigue, as observed in clinical trials[4].