Infections, Rotavirus

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine

32100%

+ 66 programs with unclassified modality

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

ViiV HealthcareNC - Durham

56 programs

Rotarix TMPhase 4

Rotarix ™Phase 4

10 valent pneumococcal conjugate vaccinePhase 3Vaccine

2-dose oral live attenuated G1P[8] human rotavirus vaccinePhase 3Vaccine

+51 more programs

GSKLONDON, United Kingdom

42 programs

Collection of stool samplesN/A1 trial

Data collectionN/A1 trial

+37 more programs

Active Trials

NCT01253967Completed1,234Est. Jan 2010

NCT01563159Completed1Est. Dec 2017

NCT01592838Completed1Est. Oct 2014

+39 more trials

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

GSKRotarix TM

GSKPCV-free liquid formulation of GSK's oral live attenuated HRV vaccine

GSKHRV PCV-free liquid vaccine

GSKSynflorix

GSK2-dose oral live attenuated G1P[8] human rotavirus vaccine

GSKLyophilized formulation of HRV vaccine

GSKHuman rotavirus liquid vaccine

GSK10 valent pneumococcal conjugate vaccine

GSK2-dose oral live attenuated G1P[8] human rotavirus vaccine

GSKLive attenuated human rotavirus vaccine

GSKRotavirus

GSK2-dose oral live attenuated G1P[8] human rotavirus vaccine

GSKRotavirus

Showing 15 of 42 trials with date data

Clinical Trials (42)

Total enrollment: 513,604 patients across 42 trials

NCT01198769 GSKRotarix TM

Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

Start: Nov 2010Est. completion: Apr 201115 patients

Phase 4Completed

NCT03954743 GSKPCV-free liquid formulation of GSK's oral live attenuated HRV vaccine

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start: Jul 2019Est. completion: Nov 20201,351 patients

Phase 3Completed

NCT02914184 GSKHRV PCV-free liquid vaccine

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start: Oct 2016Est. completion: Nov 20181,612 patients

Phase 3Completed

NCT00533507 GSKSynflorix

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

Start: Sep 2007Est. completion: Jun 2008230 patients

Phase 3Completed

NCT00382772 GSK2-dose oral live attenuated G1P[8] human rotavirus vaccine

A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).

Start: Nov 2006Est. completion: Aug 20071,200 patients

Phase 3Completed

NCT00363545 GSKLyophilized formulation of HRV vaccine

To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

Start: Sep 2006Est. completion: Apr 20071,274 patients

Phase 3Completed

NCT00345956 GSKHuman rotavirus liquid vaccine

To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)

Start: Sep 2006Est. completion: Mar 2007375 patients

Phase 3Completed

NCT00370318 GSK10 valent pneumococcal conjugate vaccine

Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines

Start: Sep 2006Est. completion: Apr 2007400 patients

Phase 3Completed

NCT00334607 GSK2-dose oral live attenuated G1P[8] human rotavirus vaccine

Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA

Start: Jun 2006Est. completion: Jun 2007484 patients

Phase 3Completed

NCT00289172 GSKLive attenuated human rotavirus vaccine

Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India

Start: Feb 2006Est. completion: Sep 2006360 patients

Phase 3Completed

NCT00134732 GSKLive attenuated human rotavirus vaccine

Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

Start: Jul 2005Est. completion: May 2006150 patients

Phase 3Completed

NCT00140686 GSKRotavirus

To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

Start: Sep 2004Est. completion: Aug 20063,994 patients

Phase 3Completed

NCT00139347 GSK2-dose oral live attenuated G1P[8] human rotavirus vaccine

Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

Start: Dec 2003Est. completion: Mar 20076,360 patients

Phase 3Completed

NCT00197210 GSKRotavirus

A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Start: Dec 2003Est. completion: Jul 200710,708 patients

Phase 3Completed

NCT00140673 GSKRotavirus

A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

Start: Aug 2003Est. completion: Oct 200563,227 patients

Phase 3Completed

NCT01110044 GSK251154 vaccine

Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Start: Apr 2010Est. completion: Aug 20120

Phase 2Withdrawn

NCT00137930 GSKLive attenuated rotavirus vaccine

Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

Start: Aug 2005Est. completion: Nov 2005250 patients

Phase 2Completed

NCT00139334 GSKRotavirus

A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh

Start: Jun 2005Est. completion: Jan 2006300 patients

Phase 2Completed

NCT00383903 GSKHRV vaccine

Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

Start: Sep 2003Est. completion: Sep 2004472 patients

Phase 2Completed

NCT00385320 GSKHRV vaccine

Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

Start: May 2001Est. completion: Apr 20032,640 patients

Phase 2Completed

NCT00729001 GSKHuman Rotavirus Vaccine - two different formulations

Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

Start: Nov 2000Est. completion: Sep 2002529 patients

Phase 2Completed

NCT00425737 GSKRotarix

Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

Start: Aug 2000Est. completion: Jul 2001405 patients

Phase 2Completed

NCT01563146 GSKData collection

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007

Start: Feb 2016Est. completion: Dec 20171 patients

N/ACompleted

NCT01563159 GSKData collection

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

Start: Mar 2015Est. completion: Dec 20171 patients

N/ACompleted

NCT01978223 GSKStool sample collection

Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis

Start: Dec 2014Est. completion: Dec 20150

N/AWithdrawn

NCT02153333 GSKSerum sample

Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™

Start: Feb 2014Est. completion: Dec 20141 patients

N/ACompleted

NCT01592838 GSKData collection

Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium

Start: Dec 2013Est. completion: Oct 20141 patients

N/ACompleted

NCT01915888 GSKData interpretation

Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination

Start: Aug 2013Est. completion: Feb 20141 patients

N/ACompleted

NCT01733849 GSKStool sample

A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia

Start: Dec 2012Est. completion: Jun 20141,266 patients

N/ACompleted

NCT01733862 GSKData collection

Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis

Start: Nov 2012Est. completion: Feb 20175,394 patients

N/ACompleted

NCT01682005 GSKData interpretation

Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotavirus (RV) Vaccination

Start: Aug 2012Est. completion: Aug 20131 patients

N/ACompleted

NCT01636739 GSKOral Rotarix®

Special Drug Use Investigation for ROTARIX®

Start: Jul 2012Est. completion: Aug 201510,982 patients

N/ACompleted

NCT01636193 GSKOral Rotarix®

Drug Use Investigation for ROTARIX®

Start: Jun 2012Est. completion: Sep 20141,607 patients

N/ACompleted

NCT01435967 GSKData collection

Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™

Start: Sep 2011Est. completion: Sep 20141 patients

N/ACompleted

NCT01339221 GSKStool samples

Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium

Start: Mar 2011Est. completion: Jun 201272 patients

N/ACompleted

NCT00938327 GSKRotarix™

Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants

Start: Aug 2009Est. completion: Apr 2010332 patients

N/ACompleted

NCT00875641 GSKHealth Insurance Database

Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States

Start: Apr 2009Est. completion: Nov 2016390,659 patients

N/ACompleted

NCT00779779 GSKRotarix™

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

Start: Nov 2008Est. completion: Aug 2009522 patients

N/ACompleted

NCT00750893 GSKRotarix or Rotarix liquid formulation

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

Start: Sep 2008Est. completion: Jun 20133,111 patients

N/ACompleted

NCT01177826 GSKSample collection

Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children

Start: Feb 2008Est. completion: Jun 2010643 patients

N/ACompleted

NCT01253967 GSKCollection of stool samples

Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Start: Feb 2008Est. completion: Jan 20101,234 patients

N/ACompleted

NCT00353366 GSKRotarix

To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

Start: Nov 2006Est. completion: Jul 20101,439 patients

N/ACompleted

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

22 late-stage (Phase 3) programs, potential near-term approvals

2 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.