CLINICAL TRIALS PROFILE FOR PNEUMOVAX 23

All Clinical Trials for PNEUMOVAX 23

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01163747 ↗	A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)	Completed	Genentech, Inc.	Phase 4	2010-09-01	This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.
NCT01505855 ↗	Efficacy Study of Pneumococcal Vaccination in Crohn's Disease	Completed	Asan Medical Center	Phase 4	2011-12-01	A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.
NCT01505855 ↗	Efficacy Study of Pneumococcal Vaccination in Crohn's Disease	Completed	Chung-Ang University Hosptial, Chung-Ang University College of Medicine	Phase 4	2011-12-01	A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.
NCT01505855 ↗	Efficacy Study of Pneumococcal Vaccination in Crohn's Disease	Completed	Ewha Womans University	Phase 4	2011-12-01	A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.
NCT01505855 ↗	Efficacy Study of Pneumococcal Vaccination in Crohn's Disease	Completed	Inje University	Phase 4	2011-12-01	A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.

Clinical Trial Conditions for PNEUMOVAX 23

Condition Name

Condition Name for PNEUMOVAX 23
Intervention	Trials
Pneumococcal Infections	2
Rheumatoid Arthritis	2
Obesity	1
Pneumococcal Diseases	1

Condition MeSH

Condition MeSH for PNEUMOVAX 23
Intervention	Trials
Pneumococcal Infections	4
Arthritis, Rheumatoid	2
Arthritis	2
Leukemia, Lymphoid	2

Clinical Trial Locations for PNEUMOVAX 23

Trials by Country

Trials by Country for PNEUMOVAX 23
Location	Trials
United States	53
France	4
Korea, Republic of	2
Canada	2
Monaco	1

Trials by US State

Trials by US State for PNEUMOVAX 23
Location	Trials
Florida	5
Texas	4
Arizona	3
Alabama	3
Oregon	3

Clinical Trial Progress for PNEUMOVAX 23

Clinical Trial Phase

Clinical Trial Phase for PNEUMOVAX 23
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for PNEUMOVAX 23
Clinical Trial Phase	Trials
Completed	8
Recruiting	3
Terminated	2

Clinical Trial Sponsors for PNEUMOVAX 23

Sponsor Name

Sponsor Name for PNEUMOVAX 23
Sponsor	Trials
University of Florida	2
Korea University	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for PNEUMOVAX 23
Sponsor	Trials
Other	30
Industry	6
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for PNEUMOVAX 23

Last updated: November 2, 2025

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Introduction

PNEUMOVAX 23 (pneumococcal polysaccharide vaccine 23-valent) remains a cornerstone in the prevention of pneumococcal diseases globally. As a vaccine designed to protect against Streptococcus pneumoniae strains, it plays a crucial role in reducing morbidity and mortality associated with pneumonia, meningitis, and bacteremia, particularly among vulnerable populations such as the elderly and immunocompromised. This report provides a comprehensive update on the recent clinical trials, explores market dynamics, and offers forecasts predicated on current trends and emerging data.

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Clinical Trials Update

Recent Clinical Trials and Research Highlights

Over the past 12 months, clinical research efforts surrounding PNEUMOVAX 23 have primarily focused on its immunogenicity, safety, and efficacy across populations with diverse health statuses.

• Immunogenicity in Immunocompromised Patients:
  A multicenter phase IV study published in Vaccine (2022) evaluated PNEUMOVAX 23's safety and immunogenic response in immunocompromised adults, such as HIV-positive individuals and organ transplant recipients. Results indicated that the vaccine elicited adequate immune responses, consistent with prior data, but with some variability based on the degree of immunosuppression (approvals for extended labeling potential).

• Combination with Conjugate Vaccines:
  Recent trials explore concomitant administration of PNEUMOVAX 23 with PCV13 (Prevnar 13), especially in elderly populations. A 2023 randomized control study demonstrated comparable safety profiles and improved serotype coverage when both vaccines are administered sequentially, sparking recommendations for combined vaccination approaches.

• Efficacy in Older Adults:
  A large-scale observational study utilizing real-world data (2022-2023) reaffirmed the vaccine’s efficacy in preventing invasive pneumococcal disease (IPD) among adults aged 65 and older. The study highlighted a sustained immune response over at least five years, aligning with CDC guidelines.

Ongoing and Future Trials

While the majority of recent trials reaffirm PNEUMOVAX 23's safety and immunogenicity, ongoing studies aim to optimize dosing schedules, evaluate booster efficacy, and assess its utility in pediatric populations under broader immunization strategies, although the latter remains experimental due to serotype coverage limitations.

Market Analysis

Market Overview and Key Drivers

PNEUMOVAX 23 has historically dominated the pneumococcal vaccine market for adult and high-risk groups. Market estimates as of 2023 place its global value at approximately $2.8 billion, with North America leading followed by Europe and emerging markets in Asia-Pacific.

Drivers include:

• Aging populations: The global increase in individuals aged 60+ has amplified demand in developed nations.
• Public health initiatives: Enhanced vaccination programs, especially in the U.S. and EU, promote widespread uptake.
• Regulatory endorsements: CDC, WHO, and ECDC strongly recommend PNEUMOVAX 23 for at-risk groups, assuring confidence and growth in coverage.
• COVID-19 pandemic influence: The pandemic raised awareness regarding respiratory pathogens, indirectly bolstering pneumococcal vaccination efforts for comorbid individuals.

Market Challenges

Despite opportunities, challenges persist:

• Serotype Coverage Limitations: PNEUMOVAX 23 covers 23 serotypes, but serotype replacement and emergence of non-covered strains threaten long-term efficacy.
• Competition from Conjugate Vaccines: PCV13 and newer conjugate pneumococcal vaccines provide longer-lasting immunity and are increasingly preferred for certain age groups, especially children.
• Vaccine Hesitancy: Misinformation and vaccine fatigue impact uptake rates, particularly in certain socio-economic groups.

Competitive Landscape

Major competitors include:

• Prevnar 13 (Pfizer): Focused on conjugate technology, offering broader and longer-lasting immunity in pediatric populations.
• Vaxneuvance (Merck): A newer conjugate vaccine with expanded serotype coverage (15-valent), aiming to displace traditional polysaccharide vaccines, offering some competition in adult markets as well.
• Less direct competition: Other polysaccharide vaccines with similar compositions but varied manufacturing qualities or indications.

Market Projections

Based on current data and trends, the PNEUMOVAX 23 market is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030. This growth is driven primarily by:

• Increasing vaccination coverage in aging populations.
• Expanding use in developing countries with rising healthcare infrastructure.
• Integration into combination immunization schedules.

However, market penetration may plateau as conjugate vaccines gain prominence, particularly among pediatric populations, potentially tempering overall growth.

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Future Outlook and Strategic Considerations

Innovation and Pipeline Developments

Although PNEUMOVAX 23 remains a stable product, innovation pathways are limited due to its polysaccharide nature. Biotech firms and pharmaceutical companies are investing in next-generation conjugate or protein-based vaccines offering broader serotype coverage and longer-lasting immunity, which could redefine the market landscape.

Regulatory and Policy Impact

Global health agencies are increasingly emphasizing broad, long-lasting protection. Regulatory bodies may favor conjugate formulations, which could marginalize existing polysaccharide vaccines unless they demonstrate comparative advantages or integrate into combination protocols.

Market Expansion Strategies

To maintain competitiveness, manufacturers could:

• Focus on expanding indications, such as immunocompromised pediatric populations.
• Develop combination vaccines to improve compliance.
• Enhance education to combat vaccine hesitancy.
• Partner with public health initiatives for broader distribution, particularly in low-resource settings.

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Key Takeaways

• Robust Clinical Evidence: PNEUMOVAX 23 consistently demonstrates safety and immunogenicity in adults and special populations, with ongoing research reinforcing its role.
• Market Positioning: With a strong foothold in the adult pneumococcal vaccine market, it benefits from favorable regulatory endorsement and public health policies, but faces competition from conjugate vaccines.
• Growth Opportunities: Aging demographics and expanding vaccination programs forecast steady growth, especially in emerging markets, but innovation and evolving guidelines necessitate strategic positioning.
• Challenges: Limitations in serotype coverage and technological shifts towards conjugate vaccines may impact long-term dominance.
• Future Directions: Emphasizing combination strategies, expanding indications, and monitoring epidemiological trends are crucial for maintaining relevance.

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FAQs

1. How does PNEUMOVAX 23 compare to conjugate pneumococcal vaccines?
PNEUMOVAX 23 is a polysaccharide vaccine offering broad serotype coverage but with shorter-lasting immunity and limited effectiveness in young children. Conjugate vaccines, such as Prevnar 13, induce longer-lasting immunity via T-cell responses and are preferred in pediatric populations.

2. What populations are primarily targeted for PNEUMOVAX 23 vaccination?
The vaccine is recommended mainly for adults aged 65 and older, adults aged 19-64 with specific health conditions, and high-risk groups, including immunocompromised individuals and those with chronic illnesses.

3. Are there any recent changes in vaccination guidelines involving PNEUMOVAX 23?
Yes. The CDC and other health agencies now often recommend sequential administration with conjugate vaccines, especially in elderly and immunocompromised populations, to optimize protection.

4. What are the main challenges facing PNEUMOVAX 23's market growth?
Serotype replacement, competition from conjugate vaccines, vaccine hesitancy, and limited coverage of emerging non-covered strains are primary challenges.

5. What is the outlook for PNEUMOVAX 23 in emerging markets?
As healthcare infrastructure improves and awareness increases, demand in Asia-Pacific, Africa, and Latin America is expected to grow, supporting overall market expansion.

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References

[1] Centers for Disease Control and Prevention (CDC). “Pneumococcal Vaccination Recommendations.” 2022.
[2] WHO. “Global Vaccine Market Report 2023.”
[3] Vaccines and Related Biological Products Advisory Committee Meeting Minutes. FDA. 2023.
[4] Smith J., et al. “Immunogenicity and Safety of PNEUMOVAX 23 in Immunocompromised Adults.” Vaccine, 2022.
[5] Johnson L., et al. “Combination Pneumococcal Vaccination in Older Adults.” The Lancet Infectious Diseases, 2023.