CLINICAL TRIALS PROFILE FOR ROTARIX

All Clinical Trials for ROTARIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00370318 ↗	Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines	Completed	GlaxoSmithKline	Phase 3	2006-09-01	The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.
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.
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).

Clinical Trial Conditions for ROTARIX

Condition Name

Condition Name for ROTARIX
Intervention	Trials
Infections, Rotavirus	1
Intussusception	1
Male Children	1
Non-cholera Patients	1

Condition MeSH

Condition MeSH for ROTARIX
Intervention	Trials
Rotavirus Infections	3
Haemophilus Infections	1
Intussusception	1
Vomiting	1

Clinical Trial Locations for ROTARIX

Trials by Country

Trials by Country for ROTARIX
Location	Trials
United States	3
Bangladesh	2
France	1
Czech Republic	1

Trials by US State

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

Clinical Trial Progress for ROTARIX

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for ROTARIX
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for ROTARIX

Sponsor Name

Sponsor Name for ROTARIX
Sponsor	Trials
International Centre for Diarrhoeal Disease Research, Bangladesh	2
Assistance Publique - Hôpitaux de Paris	1
Centers for Disease Control and Prevention	1

Sponsor Type

Sponsor Type for ROTARIX
Sponsor	Trials
Other	9
Industry	2
U.S. Fed	1

Last updated: May 2, 2026

ROTARIX: Clinical Trials Update, Market Analysis and 2026-2032 Projections

What is ROTARIX and how is it positioned clinically?

ROTARIX is a live, attenuated oral rotavirus vaccine indicated for prevention of rotavirus gastroenteritis in infants. Market use is concentrated in pediatric immunization programs, where uptake depends on national infant schedules, vaccine tender structures, and competitive dynamics versus other rotavirus vaccines.

Core product attributes (commercially relevant)

• Therapeutic class: Prophylactic vaccine (rotavirus prevention)
• Route: Oral
• Target population: Infants (routine immunization)
• Value driver: Ability to reduce severe rotavirus disease burden, which drives inclusion in national programs and pediatric procurement

Clinical evidence base shaping adoption ROTARIX’s global footprint is built on large-scale efficacy and safety trials and post-authorization surveillance. The evidence set has supported broad regulatory approvals across major markets and sustained program inclusion, despite ongoing competition from other rotavirus vaccines.

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What is the latest clinical trials and post-authorization evidence landscape for ROTARIX?

A complete “latest trials” update requires a current registry pull (e.g., ClinicalTrials.gov, EU CTR, WHO ICTRP) and a defined cutoff date, but no trial registry dataset is provided in the prompt. Per operating constraints, no partial, potentially incorrect trial listings are included.

Instead, the clinical picture that materially affects near-term commercial performance is summarized at the evidence-class level that informs procurement decisions:

Evidence categories that influence current procurement

• Efficacy and effectiveness: Demonstrated reduction in severe rotavirus gastroenteritis in infant populations across routine use settings (the basis for inclusion in immunization schedules).
• Safety profile: Live oral vaccine safety monitoring, including rare adverse event surveillance frameworks (the basis for regulatory confidence and program continuity).
• Immunization schedule compatibility: Integration with infant schedules (a key operational factor in tendering and switching decisions).

How this translates into commercial expectations

• Routine program inclusion tends to persist unless a competitor demonstrates superior program economics or effectiveness under local epidemiology.
• New RCTs or real-world studies generally influence uptake at the margin, not by replacing the established decision base unless regulators or ministries revise product preferences.

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How big is the rotavirus vaccine market and where does ROTARIX compete?

The rotavirus vaccine market is driven by:

• Birth cohort size
• National immunization program coverage and tender cadence
• Policy switching thresholds after contract awards
• Competing product availability through Gavi and national procurements

ROTARIX competes against other rotavirus vaccine franchises that target similar indications and use comparable schedules. Commercial outcomes for ROTARIX depend on:

• Country-level inclusion and formula switching inertia
• Price and procurement mechanics (volume discounts, multi-year supply agreements)
• Local temperature-stability and logistics requirements (in tenders that specify distribution capabilities)

Commercial reality of vaccine adoption

Rotavirus vaccines are generally considered “program products.” That typically means:

• Market shares shift with tender outcomes more than with consumer pull
• Adoption is schedule-locked once a national program selects a product family
• Uptake depends on cold-chain feasibility and supply reliability as much as on efficacy

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What drives ROTARIX demand in 2026-2032?

Demand is shaped by five recurring drivers:

1. Expanded infant immunization coverage

   • Growth comes from increased coverage in emerging markets rather than penetration in already saturated high-income markets.

2. Tender cycles and contract renewals

   • Rotavirus vaccine procurement often follows multi-year award structures; renewal risk is therefore contract-timing sensitive.

3. Competitive substitution

   • Switching to an alternative rotavirus vaccine can occur when ministries refresh product lists or when competitive pricing improves.

4. Real-world effectiveness expectations

   • Ministries and procurement agencies favor products with established performance under local genotype distributions and health system conditions.

5. Program budgeting and donor influence

   • In many low- and middle-income settings, donor-funded procurement and co-financing heavily influence selection and continuity.

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What is the 2026-2032 market projection for ROTARIX (scenario-based)?

A precise ROTARIX-specific forecast requires ROTARIX’s historical revenue, unit shipments, and contract coverage by geography. No such baseline is provided. Under the constraints, only a structured projection framework can be produced without embedding unsupported numeric claims.

Projection framework (units and value are scenario-derived)

Scenario A: Base case (continuation, modest share drift)

• Assumes ROTARIX retains high program inclusion in existing markets
• Assumes limited share loss to competitors mainly in tenders where pricing advantages emerge
• Growth tracks birth cohort growth and routine immunization coverage gains

Scenario B: Bear case (share erosion in price-sensitive tenders)

• Assumes accelerated substitution in countries re-tendering with stronger competitor pricing
• Assumes greater friction from supply allocation disputes or logistics constraints during contract transitions

Scenario C: Bull case (renewed contract wins and stronger inclusion)

• Assumes improved pricing competitiveness plus stable supply
• Assumes stronger inclusion momentum in expanding coverage geographies

Because no verified historical shipments or revenue figures are included in the prompt, no numeric CAGR or market share percentages are provided here.

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What risks most affect ROTARIX’s trajectory?

Key commercial risks:

• Tender re-awards: Rotavirus vaccine supply can be re-bid frequently; losing renewal can drive abrupt share shifts.
• Pricing pressure: Competitors often underbid in procurement rounds, forcing margin compression.
• Supply continuity: Program disruption risk directly affects ministry confidence and ordering patterns.
• Policy change risk: National guidance can update schedule or product lists based on new evaluations or budget changes.
• Surveillance expectations: Any perceived safety signal, even if unconfirmed, can trigger administrative delays.

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What opportunities could expand ROTARIX penetration?

Commercial upside levers:

• Higher routine coverage in currently under-immunized cohorts
• Longer contract structures that reduce per-round switching risk
• Strengthened integration with infant schedule delivery workflows in procurement countries
• Donor program co-financing that favors multi-country supply continuity

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How should investors and R&D teams interpret the clinical-to-commercial link for ROTARIX?

For program vaccines like ROTARIX, clinical evidence is table stakes. Investment focus should track:

• Regulatory and pharmacovigilance status that supports uninterrupted program inclusion
• Tender outcomes and contract renewals, which dominate short- to medium-term revenue trajectory
• Competitive positioning against alternative rotavirus vaccine franchises in each major procurement geography

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Key Takeaways

• ROTARIX is a live oral rotavirus vaccine whose demand is driven primarily by routine infant immunization program inclusion and tender mechanics.
• Current commercial performance is shaped more by country-level contract renewal and procurement dynamics than by marginal new efficacy findings.
• A credible 2026-2032 projection for ROTARIX requires historical unit/revenue baselines and an up-to-date trial registry pull; without those inputs, only a scenario-based outlook can be stated without embedding unsupported numbers.
• The most material upside is contract renewals in routine immunization programs; the most material downside is share erosion during re-tendering and pricing pressure.

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FAQs

1) What is ROTARIX’s primary market driver?

Infant immunization program inclusion supported by demonstrated clinical efficacy and sustained safety monitoring, with purchasing decided through national tenders.

2) What determines ROTARIX market share most quickly?

Tender award and contract renewal timing in each country, which can cause abrupt share changes independent of new clinical publications.

3) How do competitive products typically affect ROTARIX pricing?

Competitors often underbid in price-sensitive tenders, compressing margins and increasing the likelihood of switching during re-awards.

4) What role does safety surveillance play commercially for ROTARIX?

Safety outcomes influence regulatory comfort and ministry confidence, which can affect procurement continuity and administrative ordering speed.

5) What does “latest clinical trials update” mean for a program vaccine like ROTARIX?

For commercialization, it means changes that alter regulatory labeling, schedule recommendations, or country policy decisions, which then feed into tender specifications and ordering plans.

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References

[1] European Medicines Agency (EMA). Rotarix: Assessment history and product information. EMA. https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration (FDA). Rotarix (rotavirus vaccine, live, oral): Prescribing information and review materials. FDA. https://www.fda.gov/
[3] World Health Organization (WHO). Rotavirus vaccines: Position papers and vaccine-related guidance. WHO. https://www.who.int/
[4] ClinicalTrials.gov. Rotarix (rotavirus vaccine) clinical studies listings. U.S. National Library of Medicine. https://clinicaltrials.gov/
[5] WHO International Clinical Trials Registry Platform (ICTRP). Rotavirus vaccine studies. WHO. https://trialsearch.who.int/