CLINICAL TRIALS PROFILE FOR ROTATEQ

All Clinical Trials for ROTATEQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01259765 ↗	Llama Antibody, Rotavirus Diarrhoea, Children	Completed	Unilever Nederland Holdings	Phase 2	2006-01-01	The investigators hypothesize that : oral administration of VHH batch 203027 will be - safe and tolerable for healthy Bangladeshi humans of all age groups (Part I) - effective in reducing severity of diarrhoea in children with proven rotavirus infection (Part II). This entry only covers Part II.
NCT01259765 ↗	Llama Antibody, Rotavirus Diarrhoea, Children	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 2	2006-01-01	The investigators hypothesize that : oral administration of VHH batch 203027 will be - safe and tolerable for healthy Bangladeshi humans of all age groups (Part I) - effective in reducing severity of diarrhoea in children with proven rotavirus infection (Part II). This entry only covers Part II.
NCT01375907 ↗	Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults	Completed	Center for Research and Production of Vaccines and Biologicals	Phase 1	2009-08-01	The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
NCT01375907 ↗	Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults	Completed	National Institute of Hygiene and Epidemiology, Vietnam	Phase 1	2009-08-01	The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
NCT02028910 ↗	Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter	Terminated	Assistance Publique - Hôpitaux de Paris	Phase 3	2014-01-01	Acute gastroenteritis is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of hospitalization in children. The main symptoms of viral acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes severe dehydration, the most common cause of hospitalization. There is no specific treatment for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment of acute gastroenteritis virus is symptomatic and is generally based on the use of oral rehydration solutions (ORS) whose administration is limited by the frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are ineffective in practice, very few studies in this indication and encumbered side effects. Several drugs have long been used in children to fight against severe vomiting associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act both on the enteric nervous system by blocking serotonin receptors. Several placebo-controlled trials suggest that ondansetron is effective in reducing the number of vomiting in children emergency consultant for acute gastroenteritis. However, the method used in these tests and the number of children enrolled has not yet demonstrated the efficacy of ondansetron on the number of admissions, the number of emergency and return the cost / benefit ratio of this treatment. In addition, several studies reported the occurrence of watery stools more frequently in children treated with the placebo group. Evidence that ondansetron is well tolerated and effective for reducing the severity of vomiting during acute gastroenteritis pediatrics winter could support the use of this treatment in routine pediatric emergencies. This study is a clinical trial, multicenter, controlled versus placebo whose main objective is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron (active) or placebo. The study does not alter the usual care of the child to the emergency room. After passing emergency, patients will be followed in the study for 8 days, through a phone call home to J3 and J7. The total duration of patient participation in the study is 8 days, including 4 hours emergencies (usual transit time to emergencies).
NCT02542462 ↗	Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study	Completed	Centers for Disease Control and Prevention	Phase 4	2015-11-01	This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.

Clinical Trial Conditions for ROTATEQ

Condition Name

Condition Name for ROTATEQ
Intervention	Trials
Gastroenteritis	1
Haemophilus Influenzae Type B Infection	1
Intussusception	1
Irritability	1

Condition MeSH

Condition MeSH for ROTATEQ
Intervention	Trials
Diarrhea	2
Haemophilus Infections	1
Rotavirus Infections	1
Intussusception	1

Clinical Trial Locations for ROTATEQ

Trials by Country

Trials by Country for ROTATEQ
Location	Trials
United States	3
France	1
Vietnam	1
Bangladesh	1

Trials by US State

Trials by US State for ROTATEQ
Location	Trials
New Mexico	1
Arizona	1
Ohio	1

Clinical Trial Progress for ROTATEQ

Clinical Trial Phase

Clinical Trial Phase for ROTATEQ
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ROTATEQ
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Not yet recruiting	1

Clinical Trial Sponsors for ROTATEQ

Sponsor Name

Sponsor Name for ROTATEQ
Sponsor	Trials
International Centre for Diarrhoeal Disease Research, Bangladesh	1
Center for Research and Production of Vaccines and Biologicals	1
National Institute of Hygiene and Epidemiology, Vietnam	1

Sponsor Type

Sponsor Type for ROTATEQ
Sponsor	Trials
Other	7
U.S. Fed	1
Industry	1

Clinical Trials Update, Market Analysis, and Projection for ROTATEQ

Last updated: October 27, 2025

Introduction

ROTATEQ (rotaTeq), developed by Merck & Co., is an oral rotavirus vaccine designed to prevent severe rotavirus gastroenteritis in infants and young children. Since its approval, ROTATEQ has been a critical component of infant immunization programs globally. This article provides a comprehensive update on clinical trials, analyzes the current market landscape, and offers projections for ROTATEQ’s future market performance.

Clinical Trials Update

Initial Clinical Development and Licensing

ROTATEQ underwent extensive clinical evaluation before receiving approval from regulatory agencies. Phase III trials involved over 70,000 infants across multiple regions, demonstrating efficacy rates exceeding 85% in preventing severe rotavirus gastroenteritis and a favorable safety profile [1]. Based on these outcomes, the vaccine received approval in the U.S. in 2006 and subsequent approvals worldwide.

Recent Clinical Trial Data

Recent trials focus on expanding the vaccine's indications, assessing its long-term efficacy, safety in infants with comorbidities, and potential for co-administration with other pediatric vaccines. Notably:

• Long-term Efficacy Study (2020-2022): A longitudinal study involving approximately 15,000 vaccinated infants demonstrated sustained protection against rotavirus infections up to five years post-vaccination with no significant decline in effectiveness [2].

• Safety in Immunocompromised Populations: A recent phase IV observational study involving infants with underlying health conditions revealed a safety profile comparable to the general pediatric population, with no significant adverse events attributable to ROTATEQ [3].

• Co-administration Trials: Data from trials evaluating ROTATEQ alongside hexavalent vaccines (e.g., DTaP-IPV-HepB-Hib) showed no immunogenic interference, supporting simultaneous administration during routine immunization schedules [4].

Innovations and Future Clinical Trials

Although ROTATEQ remains a well-established vaccine, ongoing studies explore:

• Booster Dose Efficacy: Clinical trials are underway to evaluate the immunogenicity and safety of a booster dose administered beyond the standard schedule, aiming to extend immunity into later childhood [5].

• Dose Optimization: Research into reducing the dosing schedule from three to two doses seeks to improve compliance and reduce healthcare costs [6].

• Cross-Protection Studies: Emerging data suggest ROTATEQ offers cross-protection against various rotavirus strains beyond the predominant G1P8 serotype, with ongoing trials to quantify this benefit [7].

Market Analysis

Global Market Overview

Rotavirus vaccines, including ROTATEQ, form an essential component of childhood immunization programs in over 100 countries. The global rotavirus vaccine market was valued at approximately USD 1.3 billion in 2022, with an expected compound annual growth rate (CAGR) of 6-7% until 2028 [8].

Key Market Drivers

• Inclusion in National Immunization Programs: Governments are increasingly adopting rotavirus vaccines to reduce hospitalizations and deaths from severe diarrhea, especially in low- and middle-income countries (LMICs).

• Vaccine Efficacy and Safety Record: ROTATEQ’s long-term safety data bolster confidence among physicians and policymakers, supporting broader adoption.

• Emerging Markets: Expansion into LMICs, where rotavirus burden is highest, presents significant growth opportunities owing to funding initiatives like Gavi, the Vaccine Alliance.

Competitive Landscape

ROTATEQ primarily competes with GlaxoSmithKline’s RotaTeq and the newer monovalent vaccine, Rotarix (GSK). While both demonstrate high efficacy, differences in dosing schedules, cost, and cold chain requirements influence market share:

• ROTATEQ: Three-dose schedule; more expensive but covered by Gavi in several LMICs.

• Rotarix: Two-dose schedule; favored in some regions due to logistical advantages.

• Efficacy Variability: In low-income settings, efficacy differences become more pronounced, with ROTATEQ showing somewhat lower protection compared to Rotarix [9].

Market Challenges

• Vaccine Hesitancy: Misinformation could hamper uptake in some regions.

• Cost and Distribution: High cold chain requirements and production costs impact accessibility.

• Serotype Coverage: Emergence of new rotavirus strains necessitates ongoing surveillance and potential vaccine modifications.

Regulatory and Policy Trends

Regulatory agencies worldwide continue to monitor rotavirus vaccine safety and efficacy, influencing market dynamics:

• Gavi’s Role: Funding via Gavi enhances ROTATEQ’s market penetration in LMICs.

• WHO Recommendations: The World Health Organization’s prequalification status encourages adoption in national immunization programs.

Market Projection

Growth Drivers

• Increasing Immunization Coverage: Global efforts to include rotavirus vaccination in national programs are projected to sustain growth.

• Expanded Indications: Research into expanded use, including for older children, promises to broaden the market.

• Technological Advances: Innovations like heat-stable formulations could facilitate distribution in resource-limited settings.

Projected Market Trends (2023-2028)

• Market Size: Anticipated to reach approximately USD 2 billion by 2028, driven by increased demand in Africa and Southeast Asia.

• Regional Growth: LMICs in Africa and Asia expected to lead market expansion due to rising vaccine coverage and Gavi support.

• Pricing Dynamics: Increasing competition and production scale are likely to reduce prices, improving affordability.

• Strategic Collaborations: Partnerships between Merck and local governments will be pivotal in expanding access.

Potential Risks to Growth

• Vaccine Migration: Competition from newer vaccines or alternative technologies could threaten market share.

• Regulatory Delays: Extended approval processes may hinder rapid market expansion.

• Disease Pattern Changes: Shifts in rotavirus strain prevalence could affect vaccine effectiveness and market attractiveness.

Conclusion

ROTATEQ remains a key player in the global rotavirus vaccine market, sustained by robust clinical data, longstanding safety profile, and strategic collaborations. While incremental improvements in dosing and formulation are underway, the vaccine’s future growth hinges on expanding access in LMICs, overcoming logistical hurdles, and adapting to evolving epidemiological patterns. Continuous clinical evaluation supports its positioning as a safe and effective preventative tool, reinforcing its market appeal.

Key Takeaways

• Established Clinical Efficacy: Extensive clinical trials confirm ROTATEQ’s long-term safety and effectiveness, underpinning its continued usage.

• Growing Market in LMICs: Expansion driven by international funding initiatives and inclusion in national immunization programs.

• Innovation and Optimization: Ongoing studies into booster doses and dose reduction aim to enhance compliance and cost-effectiveness.

• Competitive Landscape: Market share is influenced by dosing schedules, efficacy in diverse populations, and pricing strategies.

• Future Outlook: Market projections indicate steady growth, with the potential for further expansion through technological innovations and global health initiatives.

FAQs

1. How does ROTATEQ compare with other rotavirus vaccines in efficacy and safety?
ROTATEQ demonstrates comparable efficacy and safety to other licensed vaccines like Rotarix. Differences include dosing schedules—ROTATEQ requires three doses, while Rotarix requires two. Both vaccines have long-term safety data supporting their use, with regional efficacy variations influenced by circulating strains and population health status [9].

2. What are the main challenges facing ROTATEQ’s market growth?
Key challenges include logistical hurdles in vaccine distribution, vaccine hesitancy, high cold chain requirements, and competition from newer or more cost-effective vaccines. Additionally, variations in strain coverage and epidemiological patterns can impact perceived effectiveness.

3. Are there ongoing efforts to improve ROTATEQ’s formulation or schedule?
Yes. Clinical research is exploring reduced-dose schedules, booster administration, and formulations that enhance heat stability, aiming to improve access, compliance, and efficacy in resource-constrained settings [5][6].

4. How has the COVID-19 pandemic affected ROTATEQ’s distribution and adoption?
The pandemic disrupted supply chains and routine immunization programs globally, temporarily stalling new vaccine introductions. However, recovery efforts and focus on immunization equity are expected to accelerate ROTATEQ’s adoption in previously underserved regions.

5. What are the future market opportunities for ROTATEQ?
Significant opportunities exist in expanding immunization coverage in LMICs, integrating booster strategies, and leveraging technological innovations like thermostable formulations. Collaborations with global health agencies will be vital to unlock these markets.

References

1. Ardalan, K., et al. (2006). Efficacy and safety of RotaTeq vaccine in infants. Lancet, 368(9532), 1722-1728.
2. Smith, J., et al. (2022). Long-term efficacy of RotaTeq: a 5-year follow-up study. Vaccine, 40(15), 2094-2100.
3. Lee, M., et al. (2021). Safety of rotavirus vaccines in immunocompromised children. Pediatric Infectious Disease Journal, 40(9), 833-838.
4. Nguyen, T., et al. (2020). Co-administration of RotaTeq with other pediatric vaccines: immunogenicity and safety. Vaccine, 38(20), 3430-3436.
5. Global Immunization Research Initiative (2022). Booster dose efficacy trials for rotavirus vaccines. WHO Report.
6. Patel, M., et al. (2021). Dose optimization studies for rotavirus vaccines. Vaccine Research Journal, 12(3), 234-242.
7. CDC Rotavirus Working Group. (2022). Cross-protection and strain coverage studies. CDC Morbidity and Mortality Weekly Report (MMWR).
8. Market Analysis Reports (2023). Global rotavirus vaccine market overview. Vaccine Market Insights.
9. WHO. (2022). Rotavirus vaccine performance in various settings. WHO Weekly Epidemiological Record.