Rotarix ™

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Hepatitis BDiphtheriaGastroenteritisIntussusception

252 competitors in Hepatitis B

#DrugCompanyPhaseTrials

1

Rotarix ™

GSK

Approved

12

Virazole

CConrado Roberto Hoffmann Filho

Phase 3

33

F/TDF

Gilead

Phase 3

14

Dtpa-Ipv/hib Vaccine

GSK

Phase 3

15

Dtpa-HBV-Ipv/hib

GSK

Phase 3

16

E/C/F/TAF

Gilead

Phase 3

17

Vemlidy

Gilead

Preclinical

88

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

159

Henogen HB Vaccine

HHenogen

Phase 3

110

Experimental Vaccine

Sinovac Biotech Co., Ltd

Phase 3

1Show 17 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Immunogenicity13 trials

Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age

Completed·GSK·Phase 3·NCT01978093·600 enrolled

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

Completed·GSK·Phase 3·NCT01000974·4,003 enrolled

A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

Completed·GSK·Phase 2·NCT00263666·100 enrolled

Show 10 more trials

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

Completed·GSK·Phase 3·NCT02914184·1,612 enrolled

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)

Completed·Merck & Co.·Phase 3·NCT04031846·1,184 enrolled

Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

Completed·GSK·Phase 4·NCT00969228·684 enrolled

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

Completed·GSK·Phase 3·NCT03621670·1,196 enrolled

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

Completed·GSK·Phase 3·NCT01309646·454 enrolled

Immunogenicity of 1 or 2 Doses of bOPV in Chilean Infants Primed With IPV Vaccine

Unknown status·UUniversity of Chile·Phase 4·NCT01841671·570 enrolled

Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants

Completed·Tanabe Pharma Corporation·Phase 1·NCT03507738·110 enrolled

Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

Completed·GSK·Phase 3·NCT00480324·765 enrolled

Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Completed·GSK·Phase 3·NCT02096263·585 enrolled

A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants

Completed·NNational Institute of Hygiene and Epidemiology, Vietnam·Phase 2·NCT01377571·200 enrolled

Rotavirus Vaccine12 trials

Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine

Completed·PPATH·Phase 2·NCT04344054·850 enrolled

Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa

Completed·CCentre for Infectious Disease Research in Zambia·Phase 2·NCT04658914·720 enrolled

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

Completed·GSK··NCT00750893·3,111 enrolled

Show 9 more trials

Optimising Rotavirus Vaccine in Aboriginal Children

Active, not recruiting·TTelethon Kids Institute·Phase 4·NCT02941107·1,000 enrolled

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

Completed·GSK··NCT00779779·522 enrolled

To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants

Completed·GSK·Phase 3·NCT00420745·1,009 enrolled

Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

Completed·SSeattle Children's Hospital·Phase 4·NCT00995813·15 enrolled

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT01266850·1,384 enrolled

This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine

Completed·GSK·Phase 3·NCT03207750·1,280 enrolled

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

Completed·UUniversity of Vermont·Phase 3·NCT01375647·700 enrolled

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

Completed·GSK··NCT00938327·332 enrolled

Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

Completed·GSK·Phase 3·NCT00158756·308 enrolled

Vaccination6 trials

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

Completed·GSK·Phase 3·NCT00808444·466 enrolled

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

Completed·GSK··NCT00353366·1,439 enrolled

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age

Completed·GSK·Phase 3·NCT00489554·230 enrolled

Show 3 more trials

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Active, not recruiting·Sanofi·Phase 3·NCT06824181·580 enrolled

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

Completed·GSK·Phase 3·NCT00533507·230 enrolled

Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.

Completed·GSK·Phase 3·NCT00829010·489 enrolled

Vaccine5 trials

Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Withdrawn·GSK·Phase 2·NCT01110044

Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

Completed·GSK·Phase 3·NCT00757770·854 enrolled

Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Completed·GSK·Phase 2·NCT01090453·480 enrolled

Show 2 more trials

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Recruiting·Sanofi·Phase 3·NCT06824194·2,320 enrolled

A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

Completed·GSK·Phase 3·NCT00396630·200 enrolled

Immune Response3 trials

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

Completed·GSK·Phase 2·NCT00429481·2,464 enrolled

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

Completed·GSK·Phase 2·NCT00425737·405 enrolled

A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.

Completed·GSK·Phase 2·NCT00432380·375 enrolled

13 more indications

Drug2 trials

Drug Use Investigation for ROTARIX®

Completed·GSK··NCT01636193·1,607 enrolled

Special Drug Use Investigation for ROTARIX®

Completed·GSK··NCT01636739·10,982 enrolled

Diarrhea1 trial

Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants

Completed·GSK·Phase 3·NCT00241644·2,089 enrolled

Hepatitis B1 trial

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

Completed·GSK·Phase 4·NCT01198769·15 enrolled

Children1 trial

Study to Evaluate the Safety of Rotarix™ in Chinese Children

Completed·GSK·Phase 1·NCT01086436·50 enrolled

Efficacy and Safety1 trial

Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

Completed·GSK·Phase 3·NCT00420316·1,613 enrolled

Gastroenteritis1 trial

A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India

Unknown status·PPATH·Phase 3·NCT04010448·8,200 enrolled

Randomized1 trial

Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs

Completed·NNational Institute of Pediatrics, Mexico·Phase 3·NCT02193061·1,498 enrolled

Diphtheria1 trial

Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants

Completed·GSK·Phase 4·NCT02907216·292 enrolled

Vaccines1 trial

Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

Completed·CCentre for Infectious Disease Research in Zambia·Phase 2/3·NCT03602053·450 enrolled

Adult1 trial

Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults

Completed·GSK·Phase 1·NCT01162590·52 enrolled

Treatment1 trial

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

Completed·GSK·Phase 3·NCT00370318·400 enrolled

Intussusception1 trial

Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

Completed·—·Phase 4·NCT02542462·144 enrolled

Efficacy1 trial

Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

Completed·GSK·Phase 3·NCT00329745·8,687 enrolled

Details

Drug Info

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