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
Non-cholera Patients	1
Rotavirus Infections	1
6-24 Months Old With Rotaviral Diarrhoea	1
Vomit	1

Condition MeSH

Condition MeSH for ROTATEQ
Intervention	Trials
Diarrhea	2
Nausea	1
Influenza, Human	1
Haemophilus Infections	1

Clinical Trial Locations for ROTATEQ

Trials by Country

Trials by Country for ROTATEQ
Location	Trials
United States	3
Bangladesh	1
France	1
Vietnam	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
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for ROTATEQ

Sponsor Name

Sponsor Name for ROTATEQ
Sponsor	Trials
Johns Hopkins Bloomberg School of Public Health	1
Unilever Nederland Holdings	1
International Centre for Diarrhoeal Disease Research, Bangladesh	1

Sponsor Type

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

ROTATEQ (Rotavirus Vaccine): Clinical Trials Update, Market Analysis and Projections

Last updated: April 28, 2026

What is ROTATEQ and how does it fit the rotavirus market?

ROTATEQ is a live, oral rotavirus vaccine (RV) used to prevent rotavirus gastroenteritis. It is one of two principal multinational, brand-led products competing in the routine infant immunization space, alongside GlaxoSmithKline’s Rotarix. Market structure is largely determined by:

• Birth cohort size and national immunization program coverage
• Policy alignment on the number of doses and schedule
• National procurement cycles and multi-year tender contracting
• Cold chain and delivery logistics for oral vaccines
• Local reimbursement and public-sector financing

What is the current clinical-trials and lifecycle status for ROTATEQ?

No current clinical-trials dataset with verifiable endpoints, sites, status, and timelines was provided in the request, and producing a complete, accurate clinical-trials update requires trial-by-trial evidence from registries and sponsor communications. Under the constraints, this section cannot be completed accurately.

How big is the rotavirus vaccine market and what drives ROTATEQ demand?

Rotavirus vaccination is established in high-income markets and is scaling in middle-income markets where procurement is moving from pilot introductions to routine coverage. Demand is driven by:

• Routine infant immunization adoption (national immunization schedule inclusion)
• Public-sector scale-up using pooled procurement or national tenders
• Coverage targets and dropout rates across multi-dose regimens
• Epidemiology (seasonality and hospitalization burden support payer acceptance)
• Programmatic competition between the two dominant brands

Key demand variables that translate into purchase volumes

• Eligible birth cohort × coverage rate × dose schedule adherence
• Public procurement allocation between competing brands
• Inventory behavior ahead of tender cycles

How does ROTATEQ compete versus Rotarix?

Competition centers on national procurement decisions that weigh:

• Efficacy and safety profiles in local populations (real-world performance is often considered by ministries)
• Regimen fit (number of doses and schedule logistics)
• Price and tender economics (including volume discounts)
• Supply reliability and regulatory approvals timing

Competitive landscape (high level)

Dimension	ROTATEQ	Rotarix
Product type	Oral live rotavirus vaccine	Oral live rotavirus vaccine
Market positioning	Brand in multinational immunization tenders	Brand in multinational immunization tenders
Primary decision drivers	Policy fit, procurement price, supply, local uptake	Policy fit, procurement price, supply, local uptake

What is the market outlook for rotavirus vaccines over the next 5 years?

A defensible projection requires current baseline revenues/units by geography and updated policy coverage data. The request does not include a dataset with market size, country coverage, forecast assumptions, or ROTATEQ share, and producing numeric forecasts without evidence would violate the accuracy requirement.

Under the constraints, a complete market projection cannot be issued.

What investment-relevant signals should be tracked for ROTATEQ?

Even without numeric forecasts, ROTATEQ’s performance in the market tends to be sensitive to a small set of observable signals:

Policy and procurement

• National schedule changes (dose number and timing)
• Tender awards and contract renewals (public procurement cycles)
• Eligibility expansion (routine infant cohorts; catch-up policies if adopted)

Supply and execution

• Manufacturing capacity and lead times entering peak procurement periods
• Cold chain integrity and distribution stability across delivery routes

Competitive and regulatory

• New entrants or line extensions impacting tender negotiations
• Regulatory label updates that affect national policy eligibility

What revenue and volume projection framework is used for planning (non-numeric)?

A practical projection model for ROTATEQ purchase demand typically decomposes total demand into:

1. Geography (split into countries with routine RV vaccination)
2. Eligible cohort (births)
3. Coverage rate (dose uptake through program)
4. Doses administered (dropout-adjusted)
5. ROTATEQ share of tender awards (competitive allocation)
6. Price realization (public procurement vs. private market mixes)
7. Contract timing (lumpiness around tenders)

Key Takeaways

• ROTATEQ is a routine infant rotavirus vaccine competing primarily in national immunization procurement alongside Rotarix.
• Demand is structurally driven by eligible birth cohorts, program coverage, tender cycles, and regimen logistics.
• A complete clinical-trials update and a numeric market projection cannot be produced from the provided information set under the accuracy constraints.

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FAQs

1. What immunization category is ROTATEQ in?
   Routine infant immunization to prevent rotavirus gastroenteritis.

2. Who are ROTATEQ’s primary global competitors?
   Brand-led rotavirus vaccines, led by Rotarix in most tender-driven markets.

3. What most affects ROTATEQ unit demand?
   Birth cohort size, program coverage, and dropout across multi-dose schedules.

4. What most affects ROTATEQ revenue realization?
   Public procurement pricing, contract volume, and geography-specific reimbursement and payer mix.

5. Why can market projections differ widely by year?
   Tender timing and public-sector contracting create year-to-year procurement lumpiness.

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References

[1] No sources were provided in the prompt.