CLINICAL TRIALS PROFILE FOR ROTAVIRUS VACCINE, LIVE, ORAL

All Clinical Trials for rotavirus vaccine, live, oral

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00158756 ↗	Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants	Completed	GlaxoSmithKline	Phase 3	2005-09-12	To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
NCT00168597 ↗	Vitamin A With BCG Vaccine	Completed	Leiden University Medical Center	Phase 4	2002-08-01	Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.
NCT00168597 ↗	Vitamin A With BCG Vaccine	Completed	Medical Research Council Unit, The Gambia	Phase 4	2002-08-01	Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.
NCT00168597 ↗	Vitamin A With BCG Vaccine	Completed	Bandim Health Project	Phase 4	2002-08-01	Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.
NCT00168610 ↗	Vitamin A Supplementation With Bacille Calmette Guerin (BCG) Vaccine	Unknown status	Leiden University Medical Center	Phase 4	2004-11-01	In the present study the investigators wish to address the effects of different doses of vitamin A supplementation in low and normal birth weight infants. Hypotheses: - Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in both normal and low birth weight infants. - A lower dose of vitamin A may be even more beneficial than a high dose.

Clinical Trial Conditions for rotavirus vaccine, live, oral

Condition Name

Condition Name for rotavirus vaccine, live, oral
Intervention	Trials
Rotavirus Infection	2
Rotavirus Infections	2
Intussusception	2
Morbidity	2

Condition MeSH

Condition MeSH for rotavirus vaccine, live, oral
Intervention	Trials
Rotavirus Infections	4
Gastroenteritis	2
Diarrhea	2
Intussusception	2

Clinical Trial Locations for rotavirus vaccine, live, oral

Trials by Country

Trials by Country for rotavirus vaccine, live, oral
Location	Trials
Poland	5
United States	3
Bangladesh	3
Guinea-Bissau	2
Spain	2

Trials by US State

Trials by US State for rotavirus vaccine, live, oral
Location	Trials
New Mexico	1
Arizona	1
Ohio	1

Clinical Trial Progress for rotavirus vaccine, live, oral

Clinical Trial Phase

Clinical Trial Phase for rotavirus vaccine, live, oral
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	6
Phase 3	4

Clinical Trial Status

Clinical Trial Status for rotavirus vaccine, live, oral
Clinical Trial Phase	Trials
Completed	9
Recruiting	3
Unknown status	2

Clinical Trial Sponsors for rotavirus vaccine, live, oral

Sponsor Name

Sponsor Name for rotavirus vaccine, live, oral
Sponsor	Trials
International Centre for Diarrhoeal Disease Research, Bangladesh	3
Children's Hospital Medical Center, Cincinnati	2
Leiden University Medical Center	2

Sponsor Type

Sponsor Type for rotavirus vaccine, live, oral
Sponsor	Trials
Other	32
Industry	3
U.S. Fed	2

Rotavirus Vaccine, Live, Oral: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 11, 2026

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What is the current status of clinical trials for the rotavirus vaccine, live, oral?

The global pipeline for rotavirus vaccines includes several candidates at various development stages. As of 2023, the focus lies on improving efficacy, especially in low-income regions, and expanding age indications.

• Pipeline Overview: The World Health Organization (WHO) reports about 10 candidate vaccines in clinical phases, primarily targeting enhanced immunogenicity and thermostability. These include candidates from Bharat Biotech, Serum Institute, and several biotech startups.
• Clinical Phases: Most advanced candidates are in Phase 3, with some nearing regulatory submission. For example, Bharat Biotech's ROTAVAC and Serum Institute's ROTASIIL have completed large Phase 3 trials demonstrating comparable efficacy to existing vaccines.
• Regulatory Approvals: Several vaccines received WHO prequalification between 2018-2022, including ROTAVAC and ROTASIIL, enabling widespread distribution in developing countries.
• Ongoing Trials: New formulations designed to improve coverage in infants older than traditional age groups are under evaluation. Some trials assess co-administration with other vaccines.

How does the market for live, oral rotavirus vaccines look today?

The market comprises both established products and emerging candidates, with a dominant presence of multi-dose oral vaccines for infants. The primary drivers include immunization programs in developing economies, vaccine affordability, and global health initiatives.

Market Segment	Key Players	Estimated Market Size (2022)	CAGR (2023-2027)	Notable Developments
Established Products	Rotarix (GSK), RotaTeq (Merck)	$1.2 billion	4%	Both are WHO prequalified and globally distributed
Emerging Candidates	ROTAVAC, ROTASIIL, others	$250 million	6%	Focus on low-income countries, innovative formulations

Global vaccination coverage for rotavirus is approximately 70%, with higher coverage in high-income countries and lower in Sub-Saharan Africa and South Asia. Gavi, the Vaccine Alliance, funds many vaccination initiatives in resource-limited settings, supporting market growth.

What are the key market trends influencing the outlook?

• Expansion in Low-Income Countries: WHO recommendations and Gavi support boost adoption, especially in Africa and South Asia.
• Introduction of Next-Generation Vaccines: Development of thermostable and adult formulations aims to extend the market.
• Pricing Strategies and Patent Expirations: Patent expirations of major vaccines are expected around 2028, opening the market to biosimilar and generic entrants.
• Regulatory Alignments: Streamlined approval processes in emerging markets increase the speed to market for new formulations.

What is the market projection for the next five years?

The rotavirus vaccine market is projected to grow at a compound annual growth rate of approximately 5-6% from 2023 to 2028, driven by increased immunization coverage and new product approvals.

Year	Estimated Market Size	Notes
2023	$1.5 billion	Stable, with ongoing vaccination programs
2024	$1.58 billion	New formulations in late-stage trials
2025	$1.66 billion	Expanded coverage in Africa and Asia
2026	$1.75 billion	Biosimilar entries potentially impact pricing
2028	$2.0 billion	Patents begin to expire, market diversification

Growth is constrained by high vaccination costs in developing economies, logistical challenges in distribution, and vaccine hesitancy. Nonetheless, public health priorities worldwide aim to reach universal coverage.

Key market opportunities

• Development of thermostable, single-dose formulations.
• Expanding approval for use in older infants and toddlers.
• Targeted rollouts in emerging markets with support from Gavi and WHO.
• Biosimilars entering post-patent expiration, providing lower-cost options.

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Key Takeaways

• Multiple live, oral rotavirus vaccines are in advanced clinical stages, with some nearing regulatory approval.
• The mature market is dominated by GSK’s Rotarix and Merck’s RotaTeq, both WHO-prequalified.
• Market growth is driven by increasing immunization efforts, especially in low-income countries.
• Emerging vaccines focus on thermostability, broader age indications, and lower-cost formulations.
• Patent expirations from 2028 may accelerate biosimilar development, impacting market pricing and competition.

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FAQs

1. When are new rotavirus vaccines expected to enter the market?
Most are in late-stage clinical trials, with regulatory submissions anticipated between 2024 and 2026.

2. How are emerging markets influencing the market?
They drive growth via immunization programs supported by Gavi and WHO, with a focus on lower-cost, thermostable formulations.

3. What challenges do manufacturers face?
Distribution logistics, vaccine hesitancy, and high vaccination costs impede universal uptake.

4. How will patent expirations affect the market?
Post-2028, biosimilars are expected to enter, reducing prices and increasing accessibility.

5. What is the impact of vaccine efficacy improvements?
Enhanced efficacy, especially in low-income areas, will improve coverage and reduce disease burden, boosting market expansion.

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Citations

[1] WHO, "Rotavirus Vaccines: WHO Position Paper," 2018.
[2] Gavi, The Vaccine Alliance, "Rotavirus Vaccine Introduction," 2022.
[3] MarketWatch, "Global Rotavirus Vaccine Market Size, Share, Trends & Forecast," 2022.
[4] ClinicalTrials.gov, "Rotavirus Vaccine Trials," accessed 2023.