CLINICAL TRIALS PROFILE FOR INFLUENZA VACCINE, ADJUVANTED

All Clinical Trials for influenza vaccine, adjuvanted

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00133471 ↗	Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2005-03-01	The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.
NCT00296634 ↗	H5 Vaccine Alone or With Adjuvant in Healthy Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2006-03-01	This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection of vaccine dosage levels for expanded Phase II trials based on reactogenicity and immunogenicity profiles. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved in study related procedures for up to 8 months.
NCT00912496 ↗	Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2010-06-01	This research will study safety and the body's immune (defense system) responses, including anti-H5 flu antibodies (the body's protective proteins found in the blood), to an inactivated influenza "H5" bird flu, virus vaccine. Participants will be assigned by chance to receive the vaccine injections with and without an adjuvant, (substance that can improve vaccine effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Five different vaccine dose strengths will be evaluated. About 735 healthy participants, ages 18-49 will be asked to take part in this study. Study procedures include physical exam, blood sampling, and use of a memory aid. Volunteers will participate for up to 13 months.
NCT00915187 ↗	Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly	Completed	NasVax Ltd	Phase 2	2009-10-01	To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).
NCT01239537 ↗	Swine Flu (Influenza A H1N1) Follow on Vaccine Study	Completed	University of Oxford		2010-11-01	In 2009 the World Health Organization (WHO) declared the Influenza A H1N1 (swine 'flu) outbreak the first global pandemic of this century. It is thought to have been responsible for 16,226 deaths globally as of 21st February 2010. The investigators know from previous influenza outbreaks that the number of cases also tends to increase during the winter season of the years after a pandemic. There is concern that last year's pandemic influenza strain will return this winter and it has, therefore, been included in WHO's recommendations for seasonal influenza vaccine combinations. This study will assess the duration of the immune response to the H1N1 influenza vaccines given last year, and how children will respond to this year's seasonal trivalent influenza vaccine (which includes the H1N1 strain). Participating children would receive one dose of a licensed seasonal influenza vaccine and blood tests would be taken before and after vaccination.
NCT01317745 ↗	H5N1 Mix and Match With MF59	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2011-05-01	Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2 doses separated by approximately 21 days.

Clinical Trial Conditions for influenza vaccine, adjuvanted

Condition Name

Condition Name for influenza vaccine, adjuvanted
Intervention	Trials
Influenza	12
Avian Influenza	4
Flu	1
Immunisation	1

Condition MeSH

Condition MeSH for influenza vaccine, adjuvanted
Intervention	Trials
Influenza, Human	16
Influenza in Birds	6
Sarcoidosis	1

Clinical Trial Locations for influenza vaccine, adjuvanted

Trials by Country

Trials by Country for influenza vaccine, adjuvanted
Location	Trials
United States	41
Philippines	5
Australia	4
United Kingdom	2
New Zealand	2

Trials by US State

Trials by US State for influenza vaccine, adjuvanted
Location	Trials
Texas	6
Ohio	5
Maryland	5
Tennessee	4
Iowa	4

Clinical Trial Progress for influenza vaccine, adjuvanted

Clinical Trial Phase

Clinical Trial Phase for influenza vaccine, adjuvanted
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for influenza vaccine, adjuvanted
Clinical Trial Phase	Trials
Completed	12
Active, not recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for influenza vaccine, adjuvanted

Sponsor Name

Sponsor Name for influenza vaccine, adjuvanted
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	11
Seqirus	2
Brown University	1

Sponsor Type

Sponsor Type for influenza vaccine, adjuvanted
Sponsor	Trials
NIH	12
Other	8
Industry	3

Influenza vaccine, adjuvanted Market Analysis and Financial Projection

Influenza Vaccines: Clinical Trials, Market Analysis, and Projections

Introduction to Influenza Vaccines

Influenza vaccines are a crucial component in the global effort to prevent and control influenza, a seasonal and sometimes pandemic disease. With ongoing advancements in vaccine technology and adjuvants, the landscape of influenza vaccines is evolving rapidly.

Current Clinical Trials

Novavax's COVID-19-Influenza Combination Vaccine

Novavax has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza vaccine candidates. This trial aims to evaluate the immunogenicity and safety of these vaccines in adults aged 65 and older, comparing them to Novavax's updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine. The trial builds on positive Phase 2 data and includes the use of Novavax's patented saponin-based Matrix-M adjuvant[1].

Moderna's mRNA-Based Influenza Vaccines

Moderna is also making significant strides with its mRNA-based vaccine candidates. The company's investigational seasonal flu vaccine, mRNA-1010, has demonstrated acceptable safety and tolerability across three Phase 3 trials. Additionally, Moderna's combination vaccine against flu and COVID-19, mRNA-1083, has met its primary endpoints, showing higher immune responses against both influenza and SARS-CoV-2 compared to licensed vaccines. Moderna plans to file for approval in 2024 and intends to use a Priority Review Voucher[3].

TRAC478 Adjuvant in Influenza Vaccines

Inimmune is developing a new combination adjuvant approach, TRAC478, which combines INI-2002 (a TLR4 adjuvant) and INI-4001 (a TLR7/8 adjuvant) to generate synergistic immune responses. This adjuvant is expected to be used in a 2025 NIH-funded influenza vaccine clinical trial as part of the CIVICs program, aiming to enhance the immune response against influenza[4].

Market Analysis

Global Market Size and Growth

The global influenza vaccine market was valued at USD 7.91 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 6.98% from 2024 to 2030, reaching USD 12.58 billion by 2030. This growth is driven by an increase in the incidence of seasonal flu, increased recommendations for vaccination, and surge in surveillance and government support for vaccination[2].

Key Market Segments

Quadrivalent Vaccines

The quadrivalent segment dominated the market with a share of 86.77% in 2023, due to its high efficacy against viral infections, cost-effectiveness, and easy availability. This segment is expected to continue growing at the fastest rate over the forecast period[2].

Trivalent Vaccines

The trivalent segment, while offering limited protection compared to quadrivalent vaccines, is still expected to grow at a rate of 5.0% due to its lower cost and better protection against influenza-related hospitalizations and emergency admissions in older adults[2].

Live Attenuated Vaccines

Live attenuated influenza vaccines, although commercially available since 2003, have not gained widespread acceptance due to safety concerns, minimal immunogenicity, and complex manufacturing techniques. However, advancements like the use of proteolysis-targeting chimeric (PROTAC) technology may improve their viability[2].

Market Drivers and Trends

Increased Incidence of Seasonal Flu

The global incidence of seasonal influenza, with nearly one billion cases reported annually, drives the demand for influenza vaccines. The CDC estimates that there are around 3-5 million cases of severe influenza globally each year[2].

Government Support and Surveillance

Government initiatives and increased surveillance at country and global levels have boosted the market. For example, the NIH launched the first-in-human phase I trial for an investigational influenza vaccine in June 2021, and similar initiatives are ongoing[2].

COVID-19 Impact

The COVID-19 pandemic has accelerated the adoption of influenza vaccines globally. Key market players such as Sanofi, GSK plc., AstraZeneca, and Pfizer have seen significant growth in influenza vaccine sales during the pandemic[2].

Technological Advancements

Advancements in vaccine technology, including the development of mRNA-based vaccines by Moderna and the use of novel adjuvants like TRAC478, are expected to enhance vaccine efficacy and safety. These innovations are likely to drive market growth and improve public health outcomes[3][4].

Regional Market Analysis

North America

North America leads the market with a 53.35% share, driven by the rapid launch of effective products and technologically advanced vaccine production facilities. The increasing prevalence of influenza infections in the U.S. and Canada, along with supportive government initiatives, fuels regional growth[2].

Key Players

The influenza vaccine market is dominated by several key players, including Sanofi, GSK plc., AstraZeneca, CSL Seqirus, Pfizer Inc., and Moderna. These companies are actively involved in R&D activities, strategic partnerships, and the development of combination vaccines to address both COVID-19 and influenza[2].

Adjuvanted Vaccines: Effectiveness and Safety

Adjuvanted vs. High-Dose Vaccines

Recent studies, such as the one presented at IDWeek 2024, have shown that adjuvanted inactivated influenza vaccines (aIIV) and high-dose inactivated influenza vaccines (HD-IIV) do not differ significantly in effectiveness against PCR-confirmed influenza among adults 65 years and older. Both types of vaccines also showed no difference in preventing hospitalizations or emergency department visits for PCR-confirmed influenza[5].

Future Projections

Combination Vaccines

The development of combination vaccines for COVID-19 and influenza is a significant trend. Companies like Novavax and Moderna are advancing these vaccines through clinical trials, aiming for accelerated approval pathways. These combination vaccines are expected to simplify vaccination schedules and enhance public health outcomes[1][3].

Technological Innovations

The integration of new technologies, such as mRNA platforms and advanced adjuvants, is expected to improve the efficacy, safety, and availability of influenza vaccines. These innovations will likely drive market growth and meet the increasing demand for effective influenza vaccines[3][4].

Key Takeaways

• Clinical Trials: Ongoing Phase 3 trials by Novavax and Moderna are evaluating the safety and efficacy of new influenza vaccine candidates, including combination vaccines for COVID-19 and influenza.
• Market Growth: The global influenza vaccine market is projected to grow at a CAGR of 6.98% from 2024 to 2030, driven by increased incidence of seasonal flu and government support.
• Technological Advancements: mRNA-based vaccines and new adjuvants like TRAC478 are expected to enhance vaccine efficacy and safety.
• Regional Dominance: North America leads the market due to advanced vaccine production facilities and supportive government initiatives.
• Key Players: Major pharmaceutical companies are actively involved in R&D and strategic partnerships to develop innovative influenza vaccines.

FAQs

What is the current market size of the global influenza vaccine market?

The global influenza vaccine market was valued at USD 7.91 billion in 2023[2].

Which segment dominates the influenza vaccine market?

The quadrivalent segment dominates the market with a share of 86.77% in 2023 due to its high efficacy and cost-effectiveness[2].

What are the key drivers of the influenza vaccine market?

Key drivers include the increased incidence of seasonal flu, government support and surveillance, and technological advancements in vaccine technology[2].

Which companies are leading the development of combination vaccines for COVID-19 and influenza?

Companies like Novavax and Moderna are at the forefront of developing these combination vaccines[1][3].

What is the expected growth rate of the global influenza vaccine market from 2024 to 2030?

The market is expected to grow at a CAGR of 6.98% from 2024 to 2030[2].

Sources

1. Novavax Initiates Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccine Candidates. Novavax, Inc. December 10, 2024.
2. Influenza Vaccine Market Size, Share & Growth Report, 2030. Grand View Research.
3. Moderna R&D Day Highlights Progress and Strategic Priorities. Moderna Therapeutics. September 12, 2024.
4. TRAC478 Vaccine Adjuvant. Inimmune.
5. New Data Presented at IDWeek 2024 Show Adjuvanted and High-Dose Influenza Vaccines Did Not Differ in Effectiveness. CSL Seqirus. October 18, 2024.