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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR PEDVAXHIB


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All Clinical Trials for PEDVAXHIB

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04978818 ↗ Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study) Not yet recruiting Merck Sharp & Dohme Corp. Phase 4 2021-11-15 The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.
NCT04978818 ↗ Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study) Not yet recruiting Johns Hopkins Bloomberg School of Public Health Phase 4 2021-11-15 The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for PEDVAXHIB

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Haemophilus Influenzae Type B Infection[disabled in preview]
Condition Name for PEDVAXHIB
Intervention Trials
Haemophilus Influenzae Type B Infection 1
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Condition MeSH

110-0.100.10.20.30.40.50.60.70.80.911.1Influenza, HumanHaemophilus Infections[disabled in preview]
Condition MeSH for PEDVAXHIB
Intervention Trials
Influenza, Human 1
Haemophilus Infections 1
[disabled in preview] 0
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Clinical Trial Locations for PEDVAXHIB

Trials by Country

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Trials by Country for PEDVAXHIB
Location Trials
United States 2
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Trials by US State

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Trials by US State for PEDVAXHIB
Location Trials
New Mexico 1
Arizona 1
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Clinical Trial Progress for PEDVAXHIB

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4[disabled in preview]
Clinical Trial Phase for PEDVAXHIB
Clinical Trial Phase Trials
Phase 4 1
[disabled in preview] 0
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Not yet recruiting[disabled in preview]
Clinical Trial Status for PEDVAXHIB
Clinical Trial Phase Trials
Not yet recruiting 1
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Clinical Trial Sponsors for PEDVAXHIB

Sponsor Name

trials000001111111Merck Sharp & Dohme Corp.Johns Hopkins Bloomberg School of Public Health[disabled in preview]
Sponsor Name for PEDVAXHIB
Sponsor Trials
Merck Sharp & Dohme Corp. 1
Johns Hopkins Bloomberg School of Public Health 1
[disabled in preview] 0
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Sponsor Type

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1IndustryOther[disabled in preview]
Sponsor Type for PEDVAXHIB
Sponsor Trials
Industry 1
Other 1
[disabled in preview] 0
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PEDVAXHIB: Clinical Trials, Market Analysis, and Projections

Introduction

PEDVAXHIB, a Haemophilus b Conjugate Vaccine, is a crucial component in the prevention of Haemophilus influenzae type b (Hib) infections, particularly in pediatric populations. This article delves into the recent clinical trials, market analysis, and future projections for PEDVAXHIB.

Clinical Trials and Efficacy

Protective Efficacy

PEDVAXHIB has demonstrated significant protective efficacy in clinical trials. A notable study involved Native American (Navajo) infants, where the vaccine was evaluated in a randomized, double-blind, placebo-controlled trial. The study showed that the vaccine provided substantial protection against Hib disease after a 2-dose regimen, with a follow-up period of two years and nine months[4].

Comparison with Other Vaccines

Recent studies have compared PEDVAXHIB with other vaccines, such as the DTaP-IPV-Hib-HepB vaccine (Vaxelis). A phase IV, prospective, open-label, randomized controlled clinical trial found that while the initial immunity post-dose 1 was similar between the two groups, the long-term immunity (150 days post-dose 1) was higher in the Vaxelis group. However, the study noted that the proportion of serious adverse events was similar between the groups, and none were deemed related to the study participation[1].

Adverse Reactions

Clinical trials have also reported the adverse reactions associated with PEDVAXHIB. Common adverse reactions include fever (≥101°F), irritability, and sleepiness, but these are generally mild and transient[4].

Market Analysis

Current Market Size

The global conjugate vaccine market, which includes PEDVAXHIB, was estimated at USD 19.01 billion in 2023. PEDVAXHIB is one of the key players in this market, contributing to the overall growth driven by the demand for effective vaccines against bacterial infections[5].

Market Segments

The conjugate vaccine market is segmented into monovalent and multivalent vaccines. PEDVAXHIB falls under the monovalent category but remains a vital component due to its specific protection against Hib. The market is also segmented by disease, with Hib being one of the targeted pathogens[5].

Geographic Distribution

North America is a significant market for PEDVAXHIB, given the high healthcare standards and immunization programs in the region. However, the Asia Pacific region is expected to grow at the fastest CAGR due to increasing healthcare access and the rising prevalence of infectious diseases[2][5].

Market Projections

Growth Drivers

The pediatric vaccines market, which includes PEDVAXHIB, is expected to grow significantly due to several factors:

  • Increasing Investments in Research: Advances in vaccine technology and investments in research for new multivalent vaccines are driving growth[2].
  • Expanding Healthcare Access: Emerging markets are providing untapped growth potential as healthcare access improves[2].
  • Combination Vaccines: The trend towards combination vaccines, which streamline immunization schedules, is also boosting the market[2].

Market Size and CAGR

The pediatric vaccines market, of which PEDVAXHIB is a part, is projected to grow from USD 46.95 billion in 2024 to USD 77.4 billion by 2035, at a CAGR of 4.65% between 2025 and 2035[2].

Segment Growth

The conjugate vaccine market, specifically, is expected to grow at a CAGR of 9.60% from 2024 to 2030. This rapid growth is driven by the increasing demand for conjugate vaccines, including PEDVAXHIB, in both pediatric and adult populations[5].

Key Takeaways

  • Efficacy and Safety: PEDVAXHIB has demonstrated strong protective efficacy against Hib disease with a favorable safety profile.
  • Market Position: It is a significant player in the conjugate vaccine market, particularly in the monovalent segment.
  • Growth Prospects: The market for PEDVAXHIB is expected to grow driven by increasing investments in vaccine research, expanding healthcare access, and the trend towards combination vaccines.
  • Geographic Focus: North America remains a key market, but the Asia Pacific region is expected to show the fastest growth.

FAQs

Q: What is PEDVAXHIB used for?

PEDVAXHIB is a Haemophilus b Conjugate Vaccine used to protect against Haemophilus influenzae type b (Hib) infections, particularly in infants and young children.

Q: What are the common adverse reactions associated with PEDVAXHIB?

Common adverse reactions include fever (≥101°F), irritability, and sleepiness, which are generally mild and transient[4].

Q: How does PEDVAXHIB compare to other vaccines in terms of immunity?

Recent studies have shown that while PEDVAXHIB provides similar initial immunity to some combination vaccines, the long-term immunity may vary. However, it remains effective in preventing Hib disease[1].

Q: What is the projected market growth for PEDVAXHIB?

The pediatric vaccines market, which includes PEDVAXHIB, is expected to grow from USD 46.95 billion in 2024 to USD 77.4 billion by 2035, at a CAGR of 4.65% between 2025 and 2035[2].

Q: Which regions are expected to drive the growth of the PEDVAXHIB market?

North America is currently a significant market, but the Asia Pacific region is expected to show the fastest growth due to increasing healthcare access and the rising prevalence of infectious diseases[2][5].

Sources

  1. CDC: Use of Haemophilus influenzae Type b-Containing Vaccines ... - CDC
  2. MetaTech Insights: Pediatric Vaccines Market Size, Share & Trends 2025-2035
  3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]
  4. Merck Vaccines: Efficacy of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]
  5. Research and Markets: Conjugate Vaccine Market Size, Share & Trends Analysis Report By ...

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