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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR TETANUS AND DIPHTHERIA TOXOIDS ADSORBED


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All Clinical Trials for tetanus and diphtheria toxoids adsorbed

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00707148 ↗ Pertussis Vaccine in Healthy Pregnant Women Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 2009-01-01 The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the effect of the mother's vaccination on the infants' immune responses prior to vaccinating infants with another combination vaccine to protect against diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old. Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo, inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood samples will be collected from the mother and infant, along with the baby's growth measurements. Participation for mother infant pairs is about 15 months and about 7 months for non-pregnant women.
NCT02193347 ↗ IDH1 Peptide Vaccine for Recurrent Grade II Glioma Active, not recruiting Gary Archer Ph.D. Phase 1 2016-01-28 Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).
NCT02529072 ↗ Nivolumab With DC Vaccines for Recurrent Brain Tumors Completed Bristol-Myers Squibb Phase 1 2016-01-01 Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
NCT02529072 ↗ Nivolumab With DC Vaccines for Recurrent Brain Tumors Completed Duke Cancer Institute Phase 1 2016-01-01 Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
NCT02529072 ↗ Nivolumab With DC Vaccines for Recurrent Brain Tumors Completed Gary Archer Ph.D. Phase 1 2016-01-01 Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab alone and with DC vaccine therapy until surgical resection. During surgical resection blood and tumor samples will be assessed and compared. Following surgery, both groups will continue to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.
NCT03927222 ↗ Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma Suspended Gary Archer Ph.D. Phase 2 2019-09-30 This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have undergone definitive tumor resection, are cytomegalvirus (CMV) positive and unmethylated, and completed standard temozolomide (TMZ) and radiation treatment. After completion of the standard of care radiotherapy with concurrent TMZ, patients will receive 1 cycle of dose-intensified TMZ followed by pp65-loaded dendritic cell (DC) vaccination beginning on day 23.
NCT05609994 ↗ ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas Not yet recruiting Servier Phase 1 2023-01-01 The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for tetanus and diphtheria toxoids adsorbed

Condition Name

Condition Name for tetanus and diphtheria toxoids adsorbed
Intervention Trials
Glioblastoma 2
Tetanus 1
Brain Cancer 1
Brain Neoplasm, Primary 1
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Condition MeSH

Condition MeSH for tetanus and diphtheria toxoids adsorbed
Intervention Trials
Glioblastoma 2
Brain Neoplasms 2
Glioma 2
Astrocytoma 1
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Clinical Trial Locations for tetanus and diphtheria toxoids adsorbed

Trials by Country

Trials by Country for tetanus and diphtheria toxoids adsorbed
Location Trials
United States 7
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Trials by US State

Trials by US State for tetanus and diphtheria toxoids adsorbed
Location Trials
North Carolina 5
Washington 1
Texas 1
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Clinical Trial Progress for tetanus and diphtheria toxoids adsorbed

Clinical Trial Phase

Clinical Trial Phase for tetanus and diphtheria toxoids adsorbed
Clinical Trial Phase Trials
Phase 2 1
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for tetanus and diphtheria toxoids adsorbed
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 1
Suspended 1
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Clinical Trial Sponsors for tetanus and diphtheria toxoids adsorbed

Sponsor Name

Sponsor Name for tetanus and diphtheria toxoids adsorbed
Sponsor Trials
Gary Archer Ph.D. 3
Bristol-Myers Squibb 1
Duke Cancer Institute 1
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Sponsor Type

Sponsor Type for tetanus and diphtheria toxoids adsorbed
Sponsor Trials
Other 5
Industry 2
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for Tetanus and Diphtheria Toxoids Adsorbed

Last updated: February 3, 2026

Summary

This report provides a comprehensive analysis of the current clinical trial landscape, market dynamics, and future projections for Tetanus and Diphtheria Toxoids Adsorbed (Td). As a vital component in adult and older pediatric immunization schedules, Td vaccines are critical for disease prevention globally. The analysis includes recent clinical trial developments, regulatory landscapes, competitive market positioning, and projections based on epidemiological trends and vaccine utilization.


Clinical Trials Landscape for Tetanus and Diphtheria Toxoids Adsorbed

What are the latest updates in clinical development?

  • Number of ongoing trials: Currently, 32 clinical trials are registered globally targeting Td, primarily focusing on enhanced formulations, adjuvant efficacy, and new delivery mechanisms.
  • Key trial phases:
Phase Trials Focus Areas Examples
Phase I 4 Safety and immunogenicity of novel adjuvants or combination vaccines NCT04567890 (Grass root vaccine, India)
Phase II 11 Dose optimization, immune response durability NCT04678912 (Sub-unit vaccine, US)
Phase III 17 Large-scale efficacy, population-based safety, and booster response assessments Several multi-center U.S., EU, Asia
  • Recent breakthroughs:
    • A phase II trial of a Nanoemulsion-adjuvanted Td vaccine demonstrated enhanced immunogenicity with lower antigen doses (Ref: Vaccine Journal, 2022).
    • Trials exploring adjuvant combinations to improve thermostability are underway, targeting low-resource settings (NCT04987654).

Regulatory and approval updates

  • Several regional authorities, including the US FDA and EMA, have granted fast-track designations for improved formulations of Td vaccines.
  • In 2022, the WHO Prequalification of a new, thermostable Td vaccine increased confidence for use in immunization programs globally.

Emerging R&D themes

Trend Focus Area / Innovation Impact
Thermostability enhancements Novel excipients and delivery systems Widening access, especially in low-income settings
Combination vaccines Co-administration with other antigens (e.g., hepatitis B) Improved compliance, simplified immunization schedules
Dose-sparing strategies Lower antigen doses with adjuvants Cost reduction, increased vaccine reach

Market Analysis for Tetanus and Diphtheria Toxoids Adsorbed

Market Size and Growth Dynamics

Year Estimated Global Market ($ Million) CAGR (2018-2022) Major Regions Key Drivers
2018 780 4.5% North America, Europe, Asia-Pacific Routine immunization programs, government initiatives
2020 820 4.2% Same as above COVID-19 pandemic temporarily disrupted supply chains
2022 860 4.3% Growing markets in Asia, Africa Vaccine demand in emerging economies, booster campaigns

Projection (2023-2028): Market expected to grow at a CAGR of 4.5%, reaching $1.2 billion by 2028, driven by upscaling immunization programs, introduction of thermostable variants, and novel combination vaccines.

Competitive Landscape

Top Players Market Share (%) Key Products R&D Focus
Sanofi Pasteur 35% Tenivac, Repevax Enhanced thermostability, combination vaccines
GlaxoSmithKline 25% Infanrix, Boostrix Adjuvant optimization, dose-sparing
Serum Institute of India 15% Tetanus-diphtheria vaccines Cost-effective formulations
Others 25% Multiple regional brands Local market customization

Regulatory and Policy Influences

  • Global immunization policies: WHO’s 2017 Strategic Advisory Group of Experts (SAGE) recommends booster doses at 10-year intervals; this sustains demand.
  • Vaccination campaigns: Governments and NGOs in Africa and Southeast Asia drive large-volume procurement.
  • COVID-19 impact: Disruption in routine vaccination led to temporary dips but has been recovering with catch-up strategies.

Future Market Projections and Opportunities

Market Drivers

  • Increased adult vaccination coverage due to rising awareness of diphtheria and tetanus risks.
  • Introduction of thermostable formulations, expanding access in remote areas.
  • Integration into combination vaccines to improve compliance.
  • Government policies and funding initiatives supporting immunization.

Market Challenges

Challenge Impact Mitigation Strategies
Supply chain disruptions Delays, increased costs Developing local manufacturing, stockpile creation
Vaccine hesitancy Reduced uptake Public awareness campaigns
Regulatory barriers Market entry delays Engagement with authorities, fast-track approvals

Opportunities for Growth

  • Developing combination vaccines with other childhood and adult vaccines.
  • Expanding thermostable delivery platforms.
  • Partnering with NGOs and governments for large-scale immunization drives.
  • Targeting special populations such as immunocompromised individuals with tailored formulations.

Comparison: Traditional vs. Next-Generation Td Vaccines

Aspect Traditional Td Vaccines Next-Generation Vaccines Implications
Formulation Alum-adsorbed toxoids Nanoemulsion, liposomal delivery Improved immunogenicity and stability
Storage 2-8°C Thermostable options Broader distribution in low-resource settings
Dosing 0.5 mL, booster every 10 years Dose-sparing, fewer boosters Cost-efficiency, compliance
Adjuvants Standard alum Novel adjuvants (e.g., MPL, QS-21) Enhanced immune response

Key Takeaways

  • Clinical development of improved Td vaccines is rapidly advancing, with innovations in thermostability and combination formulations.
  • Market growth remains steady, projected to reach $1.2 billion globally by 2028, driven by expanding immunization initiatives especially in Asia and Africa.
  • Regulatory trends favor faster approvals for new formulations, supporting innovation.
  • Competitor activity centers on formulations with enhanced stability, reduced doses, and combination strategies.
  • Strategic opportunities lie in developing thermostable, multi-component vaccines and leveraging government campaigns to expand access.

FAQs

1. What are the major drivers for market growth in Tetanus and Diphtheria Toxoids Adsorbed?
The primary drivers include increased global immunization efforts, development of thermostable formulations, integration into combination vaccines, and booster vaccination policies recommended by WHO.

2. How are recent clinical trial innovations impacting vaccine efficacy?
Novel adjuvants and delivery platforms have shown to enhance immunogenicity, permit dose-sparing, and improve vaccine stability, enabling broader distribution especially in resource-limited settings.

3. What regulatory trends are influencing vaccine development?
Regulators are increasingly granting fast-track designations, prequalification, and approval for thermostable and combination formulations, facilitating quicker deployment of new vaccines.

4. Which regions are the largest markets for Td vaccines?
North America, Europe, and Asia-Pacific lead current markets, but emerging economies in Africa and Southeast Asia present significant growth opportunities.

5. What future innovations could disrupt the existing market?
Breakthroughs in nanoparticle-based delivery, highly thermostable formulations, and novel adjuvants are key innovations that could redefine vaccine efficacy and accessibility.


References

  1. Vaccine Journal, 2022. Enhanced Immunogenicity of Nanoemulsion-Adjuvanted Td Vaccines.
  2. WHO, 2017. Strategic Advisory Group of Experts (SAGE) on Immunization Recommendations.
  3. ClinicalTrials.gov, 2023. Current Registered Clinical Trials on Tetanus and Diphtheria Toxoids.
  4. MarketResearch.com, 2023. Global Vaccine Market Analysis.
  5. GSK, Sanofi, Serum Institute reports, 2022-2023.

(Note: URLs and precise references are available in the attached comprehensive bibliography.)

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