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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR PENTACEL


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All Clinical Trials for PENTACEL

Trial ID Title Status Sponsor Phase Start Date Summary
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PENTACEL

Condition Name

Condition Name for PENTACEL
Intervention Trials
Pain 1
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Condition MeSH

Condition MeSH for PENTACEL
Intervention Trials
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Clinical Trial Locations for PENTACEL

Trials by Country

Trials by Country for PENTACEL
Location Trials
Canada 1
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Clinical Trial Progress for PENTACEL

Clinical Trial Phase

Clinical Trial Phase for PENTACEL
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

Clinical Trial Status for PENTACEL
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for PENTACEL

Sponsor Name

Sponsor Name for PENTACEL
Sponsor Trials
The Hospital for Sick Children 1
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Sponsor Type

Sponsor Type for PENTACEL
Sponsor Trials
Other 1
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Pentacel: Clinical Trials, Market Analysis, and Projections

Introduction to Pentacel

Pentacel is a combination vaccine designed to protect against five serious diseases: diphtheria, tetanus, pertussis (whooping cough), poliomyelitis (polio), and Haemophilus influenzae type b (Hib). It is administered to infants and young children in a series of doses.

Clinical Trials Overview

The clinical trials for Pentacel have been extensive and rigorous, involving thousands of participants.

Immune Response and Safety Studies

In the clinical trials, the immune responses to Pentacel were evaluated in several studies, including Studies 494-01, P3T06, 494-03, and M5A10. These studies compared the immunogenicity and safety of Pentacel to separately administered vaccines such as Daptacel, IPOL, and ActHIB.

  • Study M5A10: This study randomly assigned participants to receive either Pentacel or the separate vaccines Daptacel, IPOL, and ActHIB at 2, 4, and 6 months of age. The study also evaluated the concomitant administration of Pentacel with the 7-valent pneumococcal conjugate vaccine (PCV7) and the Hepatitis B vaccine[1][4].

  • Immunogenicity and Safety: The trials demonstrated that Pentacel elicited robust immune responses comparable to those of the separate vaccines. The safety profile of Pentacel was also found to be favorable, with adverse reactions similar to those observed with the individual vaccines[4].

Efficacy Against Pertussis

One of the critical aspects of these trials was the evaluation of Pentacel's efficacy against pertussis. The protective efficacy of Daptacel, a component of Pentacel, was shown to be 77.9% against mild pertussis in the Sweden I Efficacy Trial. This protection was sustained over a 2-year follow-up period[1].

Market Analysis

Current Market Size and Growth

The pentavalent vaccine market, which includes Pentacel, has been growing steadily. As of 2024, the market size was estimated to be $2.62 billion and is projected to grow to $2.73 billion in 2025, with a compound annual growth rate (CAGR) of 4.6% until 2028, reaching $3.17 billion[2].

Market Drivers

Several factors are driving the growth of the pentavalent vaccine market:

  • Global Immunization Efforts: Continued global initiatives to increase vaccination rates are a significant driver.
  • Expansion of Vaccination Programs: New geographies and populations are being targeted for vaccination, expanding the market.
  • Research and Development: Innovations in vaccine manufacturing and new formulations are contributing to market growth.
  • Collaborations and Funding: Government and international organization support, along with public awareness campaigns, are also driving the market[2].

Market Trends and Strategies

Key trends in the pentavalent vaccine market include:

  • Global Health Initiatives: Increased funding and support from global health organizations.
  • Public Awareness and Education: Campaigns to educate the public about the importance of vaccination.
  • Government Policies and Regulatory Frameworks: Favorable policies and regulations are facilitating market growth.
  • Technological Innovations: Advances in vaccine manufacturing and distribution are improving accessibility and efficacy[2].

Regional Market Segmentation

The pentavalent vaccine market is segmented by region, with detailed analyses for Western Europe, the UK, Germany, North America, the USA, Canada, and South America. Each region has its own market size, growth projections, and segmentation by type, formulation, and application[2].

Projections and Future Outlook

Market Growth Projections

The pentavalent vaccine market, including Pentacel, is expected to continue its steady growth. The market is projected to reach $3.17 billion by 2028, driven by the factors mentioned above. The CAGR of 4.6% indicates a robust and sustained growth trajectory[2].

Impact of Global Events

The market has been resilient despite global challenges such as the COVID-19 pandemic and the Ukraine-Russia war. These events have had some impact, but the overall trend remains positive due to the critical nature of vaccination programs[2].

Key Takeaways

  • Clinical Trials: Pentacel has undergone extensive clinical trials, demonstrating its safety and efficacy.
  • Market Growth: The pentavalent vaccine market is growing steadily, driven by global immunization efforts, technological innovations, and favorable government policies.
  • Regional Segmentation: The market is segmented by region, with detailed analyses for various countries and regions.
  • Future Outlook: The market is projected to continue growing, reaching $3.17 billion by 2028.

FAQs

What diseases does Pentacel protect against?

Pentacel protects against diphtheria, tetanus, pertussis (whooping cough), poliomyelitis (polio), and Haemophilus influenzae type b (Hib)[1].

What were the key findings of the clinical trials for Pentacel?

The clinical trials showed that Pentacel elicited robust immune responses comparable to those of the separate vaccines and had a favorable safety profile[1][4].

What is the current market size of the pentavalent vaccine market?

As of 2024, the market size was estimated to be $2.62 billion[2].

What factors are driving the growth of the pentavalent vaccine market?

The growth is driven by global immunization efforts, expansion of vaccination programs, research and development initiatives, and collaborations for vaccine access[2].

What is the projected market size of the pentavalent vaccine market by 2028?

The market is projected to reach $3.17 billion by 2028, with a CAGR of 4.6%[2].

Sources

  1. eMPR.com: PENTACEL Prescription & Dosage Information - MPR - eMPR.com
  2. The Business Research Company: Pentavalent Market Report 2025
  3. PR Newswire: Pertussis Market to Garner Considerable Growth at 1.4% CAGR ...
  4. Sanofi US: Federal Advisory Committee Votes to Include Newly Licensed ...

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