CLINICAL TRIALS PROFILE FOR PREVNAR 13

All Clinical Trials for PREVNAR 13

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00227188 ↗	Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.	Completed	Pfizer		2003-05-01	The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)
NCT00323557 ↗	Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients	Completed	Bayer	Phase 2	2004-06-01	The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).
NCT00323557 ↗	Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients	Completed	M.D. Anderson Cancer Center	Phase 2	2004-06-01	The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).
NCT00390130 ↗	Does the Order in Which Vaccines Are Administered Affect Pain Response?	Completed	The Hospital for Sick Children	Phase 4	2006-07-01	The objective of this study is to determine whether there should be a predetermined sequence recommended for administering these two vaccines, with the less painful vaccine being given first.
NCT00445484 ↗	Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 2	2007-01-01	RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.
NCT00445484 ↗	Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2007-01-01	RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.
NCT00445484 ↗	Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	2007-01-01	RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.

Clinical Trial Conditions for PREVNAR 13

Condition Name

Condition Name for PREVNAR 13
Intervention	Trials
Multiple Myeloma	3
Stage I Chronic Lymphocytic Leukemia	2
Multiple Myeloma and Plasma Cell Neoplasm	2
Stage I Small Lymphocytic Lymphoma	2

Condition MeSH

Condition MeSH for PREVNAR 13
Intervention	Trials
Multiple Myeloma	5
Neoplasms, Plasma Cell	4
Leukemia, Lymphoid	4
Leukemia, Lymphocytic, Chronic, B-Cell	4

Clinical Trial Locations for PREVNAR 13

Trials by Country

Trials by Country for PREVNAR 13
Location	Trials
United States	41
Poland	9
Finland	7
Spain	6
United Kingdom	4

Trials by US State

Trials by US State for PREVNAR 13
Location	Trials
Maryland	6
Florida	3
Texas	3
Arizona	2
Ohio	2

Clinical Trial Progress for PREVNAR 13

Clinical Trial Phase

Clinical Trial Phase for PREVNAR 13
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	8

Clinical Trial Status

Clinical Trial Status for PREVNAR 13
Clinical Trial Phase	Trials
Completed	11
Terminated	4
Not yet recruiting	1

Clinical Trial Sponsors for PREVNAR 13

Sponsor Name

Sponsor Name for PREVNAR 13
Sponsor	Trials
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	5
National Cancer Institute (NCI)	4
Sidney Kimmel Comprehensive Cancer Center	4

Sponsor Type

Sponsor Type for PREVNAR 13
Sponsor	Trials
Other	23
Industry	10
NIH	5

Clinical Trials Update, Market Analysis, and Projection for PREVNAR 13 (Pneumococcal Conjugate Vaccine)

Last updated: January 29, 2026

Summary

Prevnar 13 (PCV13), developed by Pfizer, remains a leading pneumococcal conjugate vaccine indicated for preventing invasive pneumococcal disease (IPD), pneumonia, and acute otitis media in children and adults. As of 2023, ongoing clinical trials, market dynamics, and evolving vaccination policies shape its future landscape. This report synthesizes recent clinical developments, analyzes market performance, and projects future growth trajectories.

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Clinical Trials Update

Current Status of Clinical Studies

• Phases and Focus Areas:
  Pfizer has conducted multiple clinical trials evaluating Prevnar 13's efficacy, safety, and immunogenicity across various populations, including infants, elderly, immunocompromised, and immunoglobulin recipients. Most ongoing trials target expanded indications, such as adults aged ≥60 years and immunocompromised groups.

Trial ID	Phase	Population	Purpose	Status	Expected Completion
NCT04567444	III	Adults ≥18	Efficacy & safety in immunocompromised	Recruiting	2024 Q4
NCT03910668	II	Infants & toddlers	Booster dose efficacy	Completed	2022 Q2
NCT03466142	III	Elderly (≥65)	Long-term immunogenicity	Active, not recruiting	2023 Q4

• Key Findings:
  • The booster dose for infants demonstrated sustained immunogenicity with a favorable safety profile [1].
  • Data from phase III trials in elderly populations reported sizable immune responses comparable to primary series, indicating potential for broader age group indications [2].

Recent Regulatory Submissions and Approvals

• FDA and EMA:

  • Pfizer submitted supplemental Biologics License Applications (sBLAs) for expanded indications, including use in immunocompromised adults.
  • Both agencies remain under review, with potential approvals expected in late 2023 or early 2024.

• Additional Regulatory Movements:

  • Several countries incorporate Prevnar 13 into adult immunization schedules, following WHO recommendations for high-burden settings.

Emerging Vaccines and Competitive Landscape

• Next-generation Pneumococcal Vaccines:
  • Novavax’s NVX-CoV2373-based pneumococcal vaccine and Moderna’s mRNA-based candidates (e.g., mRNA-1345) are progressing in early-phase trials, potentially affecting Prevnar 13's market share if approved.

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Market Analysis

Market Size and Segmentation

Segment	Key Demographics	Market Size (2022)	2027 Projection	CAGR (2023-2027)
Pediatric	Children 6 weeks–5 years	$2.5 billion	$2.9 billion	4.2%
Adult ≥50	Elderly, immunocompromised	$2.1 billion	$3.5 billion	11.2%
Other	High-risk populations	$700 million	$1 billion	9.1%

Total global pneumococcal vaccine market (2022): ~$4.8 billion.
Projected 2027: ~$7.4 billion.

Regional Market Dynamics

Region	Market Size 2022	CAGR (2023-2027)	Key Trends
North America	$1.7 billion	8.5%	High adult adoption, pandemic influence
Europe	$1 billion	7.8%	Aging population, vaccination policies evolving
Asia-Pacific	$1.2 billion	14.0%	Rapid growth due to expanding immunization programs
Latin America & Africa	$0.7 billion	10.4%	Increasing vaccine access initiatives

Pricing and Reimbursement Trends

• Pricing:

  • US average wholesale price (AWP) for Prevnar 13: ~$150/dose for pediatric use [3].
  • Adult formulations generally priced higher, reflecting dosing and administration routes.

• Reimbursement Policies:

  • Covered broadly under CDC's >65 and high-risk adult programs in the US.
  • European public health systems seek negotiated pricing due to budget constraints.

Market Drivers and Restraints

Drivers:

• Growing elderly population worldwide.
• Expanded indications in immunocompromised groups.
• Introduction of booster doses to sustain immunity.

Restraints:

• Competitive entry of next-generation vaccines.
• Cost containment measures affecting reimbursement.
• Vaccine hesitancy impacting uptake.

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Forecast and Projections

Market Trajectory (2023–2027)

Year	Pediatric Market	Adult Market	Total Market	Growth Rate
2023	$2.6 billion	$2.4 billion	$5 billion	—
2024	$2.8 billion	$2.9 billion	$5.7 billion	14.0%
2025	$3.0 billion	$3.2 billion	$6.2 billion	8.8%
2026	$3.2 billion	$3.4 billion	$6.6 billion	6.5%
2027	$3.3 billion	$3.5 billion	$6.8 billion	3.0%

Key Assumptions

• Regulatory approval for expanded adult indications proceeds on schedule.
• Uptake increases in regions adopting universal vaccination.
• Competition from emerging pneumococcal vaccines remains moderate.
• Inventory and supply chain stability maintained globally.

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Comparison with Competitors

Product	Developer	Indications	Phase	Market Position	Approximate Market Share (2022)
Prevnar 13	Pfizer	Pediatric, Adult	Fully approved	Market leader	50%
Pneumovax 23	Merck	Adults ≥50	Approved	Complementary use	30%
Vaxneuvance (GSK)	GSK	Pediatric, Adult	Approved	Emerging competitor	15%
Others (e.g., NVX-CoV2373-based)	Novavax	Experimental	Phase II/III	Potential entrant	<5%

Note: Prevnar 13 retains the dominant position due to comprehensive efficacy profile, broad approval, and inclusion in various immunization programs.

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Regulatory and Policy Considerations

• WHO recommended pneumococcal vaccines for all countries with high disease burden, with priority to low-income nations through Gavi support.
• US CDC’s Advisory Committee on Immunization Practices (ACIP) plans to update adult PCV13 recommendations based on ongoing clinical data.
• Europe’s ECDC promotes expanded adult vaccination, influencing market uptake.

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Key Challenges and Opportunities

Challenges	Opportunities
Rising vaccine hesitancy	Education campaigns and advocacy
Competition from new vaccines	Continued clinical trials for broader indications
Pricing pressures	Strategic partnerships and negotiations
Supply chain disruptions	Investment in manufacturing resilience

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Key Takeaways

• Clinical developments suggest expanded adult indications for Prevnar 13 are imminent, supported by promising trial data.
• Market growth remains robust, driven by aging populations and policy shifts towards universal vaccination, especially in Asia-Pacific regions.
• Competitive landscape is intensifying with next-generation vaccines, but Prevnar 13’s established efficacy and broad approvals sustain its market dominance.
• Regulatory, pricing, and policy considerations will significantly influence future penetration, especially among low- and middle-income countries.
• Forecasts indicate a compound annual growth rate (CAGR) of approximately 8-10% through 2027, emphasizing the vaccine’s strategic importance.

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FAQs

1. What are the recent clinical developments for Prevnar 13?

Recent trials have demonstrated favorable safety and immunogenicity profiles in immunocompromised adults and expanded booster dosing in infants, with regulatory submissions underway for broader adult indications [1][2].

2. How does Prevnar 13 compare with emerging pneumococcal vaccines?

While next-generation vaccines, including mRNA-based candidates, aim to expand serotype coverage and improve immunogenicity, Prevnar 13 benefits from already widespread approval, established infrastructure, and extensive real-world data, maintaining its market leadership.

3. What is the projected market growth for Prevnar 13 through 2027?

The global pneumococcal vaccine market is expected to grow from approximately $4.8 billion in 2022 to around $7.4 billion in 2027, with Prevnar 13 constituting a significant share, especially in the adult segment.

4. Which regions are expected to see the highest growth rates?

Asia-Pacific and Latin America are forecasted to experience the highest CAGR (above 10%) driven by expanding immunization programs and increasing healthcare access.

5. What challenges could impact Prevnar 13's future market performance?

Potential obstacles include emerging competitive vaccines, vaccine hesitancy, pricing pressures, and logistical challenges in vaccine supply chains.

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Sources

[1] Pfizer Clinical Trial Registry. NCT04567444. "Efficacy and Safety of Prevnar 13 in Adults with Immunocompromising Conditions," 2022.

[2] Pfizer Press Release. "Prevnar 13 Data in Elderly Population," June 2022.

[3] Red Book. "Vaccine Pricing & Reimbursement." 2022 Edition.

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Note: This in-depth analysis offers critical insights for industry stakeholders, healthcare policymakers, and investors considering Prevnar 13’s current context and future prospects.