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Rotavirus Infections

13
Pipeline Programs
9
Companies
9
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
1
0
9
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
8100%
+ 10 programs with unclassified modality

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
5 programs
4
RotaTeq™, rotavirus vaccine, live, oral, pentavalentPhase 3Vaccine
Rotateq™Phase 3
Rotavirus Vaccine, Live, Oral, PentavalentPhase 3Vaccine
rotavirus vaccine, live, oral, pentavalentPhase 3Vaccine
ROTATEQ™ Post-Marketing Surveillance in the PhilippinesN/A
MSD
MSDIreland - Ballydine
5 programs
4
RotaTeq™, rotavirus vaccine, live, oral, pentavalentPhase 3Vaccine1 trial
Rotateq™Phase 31 trial
Rotavirus Vaccine, Live, Oral, PentavalentPhase 3Vaccine1 trial
rotavirus vaccine, live, oral, pentavalentPhase 3Vaccine1 trial
ROTATEQ™ Post-Marketing Surveillance in the PhilippinesN/A1 trial
Active Trials
NCT01357174Terminated915Est. Sep 2010
NCT00092443Completed1,312Est. Jun 2004
NCT00090233Completed69,274Est. Oct 2004
+2 more trials
Bharat Biotech
Bharat BiotechIndia - Hyderabad
1 program
1
ROTAVAC®Phase 31 trial
Active Trials
NCT03367559Unknown360Est. May 2019
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
RotavirusPhase 2
Applied Medical
Applied MedicalCA - Rancho Santa Margarita
2 programs
2
116E AGMKPhase 11 trial
Live Attenuated Rotavirus Vaccine Candidate Strains 116EPhase 1Vaccine
Active Trials
NCT00280111Completed90Est. May 2005
Applied Medical Technology
1 program
1
116E AGMKPhase 1
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
ROTATEQ™ Post-Marketing Surveillance in the PhilippinesN/A
MAXVAX Biotechnology
MAXVAX BiotechnologyChina - Chengdu
1 program
Mid dose Recombinant Trivalent Subunit Rotavirus VaccinePHASE_2Vaccine1 trial
Active Trials
NCT05621655Active Not Recruiting1,512Est. Dec 2024
GSK
GSKLONDON, United Kingdom
1 program
RotavirusPHASE_21 trial
Active Trials
NCT00346892Completed450

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Bharat BiotechROTAVAC®
MSDRotavirus Vaccine, Live, Oral, Pentavalent
MSDrotavirus vaccine, live, oral, pentavalent
MSDRotaTeq™, rotavirus vaccine, live, oral, pentavalent
MSDRotateq™
MAXVAX BiotechnologyMid dose Recombinant Trivalent Subunit Rotavirus Vaccine
GSKRotavirus
Applied Medical116E AGMK
MSDROTATEQ™ Post-Marketing Surveillance in the Philippines

Clinical Trials (9)

Total enrollment: 75,441 patients across 9 trials

NCT03367559Bharat BiotechROTAVAC®

Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam

Start: Feb 2018Est. completion: May 2019360 patients
Phase 3Unknown
NCT00130832MSDRotavirus Vaccine, Live, Oral, Pentavalent

Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Start: Oct 2005Est. completion: Jul 2006735 patients
Phase 3Completed
NCT00092456MSDrotavirus vaccine, live, oral, pentavalent

Consistency Lots Vaccine Study (V260-009)

Start: May 2003Est. completion: Aug 2004793 patients
Phase 3Completed
NCT00092443MSDRotaTeq™, rotavirus vaccine, live, oral, pentavalent

Dose Confirmation Efficacy Study (V260-007)

Start: Sep 2002Est. completion: Jun 20041,312 patients
Phase 3Completed
NCT00090233MSDRotateq™

Rotavirus Efficacy and Safety Trial (REST)(V260-006)

Start: Jan 2001Est. completion: Oct 200469,274 patients
Phase 3Completed
NCT05621655MAXVAX BiotechnologyMid dose Recombinant Trivalent Subunit Rotavirus Vaccine

Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers

Start: Jan 2023Est. completion: Dec 20241,512 patients
Phase 2Active Not Recruiting
NCT00346892GSKRotavirus

To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV

Start: Nov 2001450 patients
Phase 2Completed
NCT00280111Applied Medical116E AGMK

Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants

Start: Jan 2005Est. completion: May 200590 patients
Phase 1Completed
NCT01357174MSDROTATEQ™ Post-Marketing Surveillance in the Philippines

ROTATEQ™ Post-Marketing Surveillance in the Philippines

Start: Oct 2007Est. completion: Sep 2010915 patients
N/ATerminated

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

9 late-stage (Phase 3) programs, potential near-term approvals
9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.