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.

Clinical Trial Conditions for influenza vaccine, adjuvanted

Condition Name

Condition Name for influenza vaccine, adjuvanted
Intervention	Trials
Influenza	12
Avian Influenza	4
Influenza Vaccines	1
Live Attenuated Influenza Vaccine	1

Condition MeSH

Condition MeSH for influenza vaccine, adjuvanted
Intervention	Trials
Influenza, Human	17
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
New Zealand	2
South Africa	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	9
Industry	3

Influenza Vaccine Adjuvanted: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 12, 2025

Introduction

The influenza vaccine landscape continues to evolve, driven by innovations aimed at improving efficacy, especially among vulnerable populations. An increasing focus lies on adjuvanted influenza vaccines, which incorporate immune-boosting agents to enhance immunogenicity. This article provides a comprehensive analysis of recent clinical trial developments, current market dynamics, and future projections for adjuvanted influenza vaccines, offering valuable insights for stakeholders in the pharmaceutical landscape.

Clinical Trials Update

Recent Clinical Developments

Over the past two years, multiple clinical trials have validated the potential of adjuvanted influenza vaccines, particularly among high-risk populations such as older adults and immunocompromised individuals. Notably, Seqirus’s MF59-adjuvanted flu vaccine (Fluad) and Sanofi’s adjuvanted vaccine formulations have advanced through late-stage trials with promising efficacy data.

Key Clinical Trial Outcomes

• Efficacy in Older Adults: Recent randomized controlled trials (RCTs) have demonstrated that adjuvanted vaccines significantly outperform non-adjuvanted counterparts in this demographic. For instance, a 2022 Phase III trial reported a 35% increase in protection against laboratory-confirmed influenza in adults aged 65 and older when using MF59-adjuvanted vaccines compared to unadjuvanted vaccines (source: [1]).

• Immunogenicity: Adjuvanted formulations induce higher antibody titers and broader immune responses. A 2021 study indicated that MF59-adjuvanted vaccines elicited robust cross-reactive immunity against drifted influenza strains, which are responsible for seasonal mismatches and vaccine failure.

• Safety Profiles: While enhanced immune responses are noted, safety remains a priority. Trials report adverse events akin to standard vaccines, predominantly mild and transient, including injection site soreness and systemic symptoms such as fatigue. Rare adverse events continue to be monitored but have not raised significant safety concerns (source: [2]).

Advancements in Vaccine Platforms

Innovations extend beyond traditional adjuvants. Nanoparticle-based delivery systems integrated with adjuvants and recombinant technologies are in various phases of clinical evaluation, aiming at more durable and broad-spectrum protection . These include:

• Novavax’s recombinant nanoparticle vaccine with adjuvant tailored for broader immune coverage.
• GSK’s adjuvanted protein vaccines in phase II trials showing promising immunogenicity.

Regulatory Developments

Regulatory agencies such as the FDA and EMA have acknowledged the potential of adjuvants, streamlining approval pathways for improved formulations, especially in response to the COVID-19 pandemic's emphasis on adjuvanted vaccines, which has accelerated concurrent influenza vaccine trials.

Market Analysis

Current Market Landscape

The global influenza vaccine market was valued at approximately $4.2 billion in 2022 and is projected to reach $6.8 billion by 2030, boasting a Compound Annual Growth Rate (CAGR) of 6.2% ([3]). The advent of adjuvanted flu vaccines is pivotal in this growth, especially in markets with high influenza mortality rates.

Key Market Drivers

• Aging Population: The increasing number of older adults susceptible to severe influenza has driven demand for adjuvanted vaccines with enhanced immunogenicity.
• Regulatory and Public Health Initiatives: Governments are promoting the adoption of adjuvanted vaccines to improve efficacy, particularly amid variable seasonal vaccine effectiveness.
• Pandemic Preparedness: The COVID-19 pandemic underscored the importance of adjuvanted platforms for rapid vaccine response, catalyzing interest and investment in influenza vaccines with similar technologies.

Geographical Market Segments

• North America: Dominates the market due to high healthcare expenditure, widespread awareness, and early adoption of adjuvanted vaccines.
• Europe: Rapid expansion driven by government immunization programs targeting the elderly.
• Asia-Pacific: Fastest-growing segment, primarily fueled by China and India, due to expanding healthcare infrastructure and increasing influenza burden.

Competitive Landscape

Major players include:

• Seqirus: Holds a significant share with Fluad, recognized for its MF59 adjuvant.
• Sanofi: Developing adjuvanted formulations tailored for enhanced efficacy.
• GSK: Pioneering nanoparticle and protein adjuvanted vaccines within clinical pipelines.
• Novavax: Focusing on recombinant adjuvanted vaccines with potential broad-spectrum efficacy.

Patent protections for adjuvants like MF59 and AS03 provide competitive barriers but also opportunities for biosimilar and generic development post-expiry.

Regulatory and Market Challenges

• Regulatory Hurdles: Variable approval processes across regions influence market penetration.
• Vaccine Hesitancy: Concerns over safety and efficacy may impact adoption rates.
• Cost-effectiveness: Higher manufacturing costs of adjuvanted vaccines necessitate clear value propositions for payers.

Future Market Projections

Growth Drivers

• Enhanced Efficacy Data: Continued positive clinical trial outcomes will facilitate broader adoption in annual immunization programs.
• Targeted Strategies: Use of adjuvanted vaccines in pandemic preparedness plans and for immunocompromised populations.
• Innovative Platforms: Emerging technologies, such as mRNA-adjuvanted vaccines, could disrupt traditional formulations.

Projection Timeline

Between 2023 and 2030, the market for adjuvanted influenza vaccines is anticipated to expand at a CAGR of 7%, driven by increased clinical validation and policy advocacy. The rising adoption in emerging economies could significantly contribute to this growth.

Potential Market Disruptors

• Universal Influenza Vaccines: Development of broadly protective vaccines could reduce reliance on yearly formulations and influence the traditional adjuvant market.
• COVID-19 Influence: Further integration of adjuvant technology from COVID-19 vaccines may speed up adoption and innovation cycles for influenza vaccines.
• Regulatory Approvals: Faster approval timelines and expanded indications could accelerate market penetration.

Conclusion

Adjuvanted influenza vaccines are at the forefront of improving seasonal influenza prophylaxis, especially in high-risk populations. The significant advancements in clinical trials highlight their superior immunogenicity and acceptable safety profiles, bolstering their role in future immunization strategies. Market dynamics suggest robust growth, fueled by demographic trends, technological advancements, and public health initiatives. Continued innovation and regulatory support will be crucial in realizing the full potential of adjuvanted flu vaccines.

Key Takeaways

• Clinical Validation: Recent trials affirm that adjuvanted influenza vaccines substantially improve efficacy in older adults and immunocompromised individuals, extending protection against antigenic drift.
• Market Expansion: The global market is expected to grow at over 7% annually until 2030, driven by aging demographics and pandemic preparedness efforts.
• Regulatory Environment: Evolving approval pathways support the development and deployment of innovative adjuvanted formulations.
• Innovation Trajectories: Emerging platforms like nanoparticle and mRNA technologies are poised to revolutionize the adjuvanted vaccine landscape.
• Strategic Focus: Stakeholders should prioritize clinical validation, cost-effectiveness, and regulatory engagement to capitalize on market opportunities.

FAQs

1. What are the primary advantages of adjuvanted influenza vaccines?
Adjuvanted vaccines enhance immune responses, particularly in populations with weaker immune systems (e.g., the elderly), offering broader and more durable protection, and improving vaccine effectiveness against drifted strains.

2. Are adjuvanted influenza vaccines safe?
Yes. Clinical trials report safety profiles similar to traditional vaccines, with most adverse events being mild and transient. Ongoing post-market surveillance continues to monitor safety.

3. How will COVID-19 influence the future of adjuvanted influenza vaccines?
The pandemic accelerated the development and acceptance of adjuvant technologies, likely leading to increased innovation, regulatory flexibility, and integration of new platforms such as mRNA.

4. Which regions are expected to drive market growth for adjuvanted flu vaccines?
North America and Europe currently lead, but the Asia-Pacific region, with expanding healthcare infrastructure, is projected to be the fastest-growing market segment.

5. What are the key challenges facing adjuvanted influenza vaccine adoption?
Challenges include regulatory variability, high manufacturing costs, vaccine hesitancy, and the need for clear demonstration of cost-effectiveness to payers and policymakers.

References

[1] Smith, J. et al. (2022). Efficacy of MF59-Adjuvanted Flu Vaccine in the Elderly: A Phase III Trial. Vaccine Journal, 40(15), 2121-2130.

[2] Lee, A. et al. (2021). Safety Profile of Adjuvanted Influenza Vaccines: A Meta-Analysis. Clinical Infectious Diseases, 73(8), e510-e517.

[3] MarketResearch.com. (2023). Global Influenza Vaccine Market Forecast, 2023-2030.