29 completed, 2 active not recruiting, 2 unknown. 18 Phase 3, 7 Phase 2, 6 Phase 4, 1 Phase 1.
By phase and status
Follow Rotarix: new trials by email Literature Review of Rotarix trials Research Report on Rotarix
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
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
PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine - Pneumococcal Immunization | Phase 3 | Active not recruiting | Sanofi | 580 | 2025-02-27 | 2026-02-13 |
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine - Pneumococcal Immunization | Phase 3 | Active not recruiting | Sanofi | 2360 | 2025-02-18 | 2026-04-13 |
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
GSK's liquid oral live attenuated HRV, PCV-free liquid formulation of GSK's oral live attenuated HRV - Gastroenteritis | Phase 3 | Completed | GlaxoSmithKline | 2000 | 2023-09-01 | 2025-05-09 |
Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa
Rotarix, Trivalent P2-VP8 - Diarrhea, Diarrhea Rotavirus | Phase 2 | Completed | Centre for Infectious Disease Research in Zambia | 720 | 2021-04-15 | 2025-05-15 |
Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine
RV3-BB, Trivalent P2-VP8, Rotarix - Rotavirus Vaccine | Phase 2 | Completed | PATH | 850 | 2021-02-22 | 2022-11-29 |
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
TV P2-VP8, Rotarix - Rotavirus Infection of Children | Phase 3 | Unknown | PATH | 8200 | 2019-10-10 | 2021-04-09 |
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, Pediarix - Infections, Meningococcal | Phase 3 | Completed | GlaxoSmithKline | 1196 | 2018-07-27 | 2026-08-20 |
Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
MT-5625 low dose, MT-5625 middle dose, MT-5625 high dose - Healthy | Phase 1 | Completed | Tanabe Pharma Corporation | 110 | 2018-07-03 | 2019-08-06 |
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
Rotarix, Pediarix, Hiberix - Rotavirus Infection, Rotavirus Vaccines | Phase 3 | Completed | GlaxoSmithKline | 1280 | 2017-09-14 | 2020-12-29 |
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
HRV PCV-free liquid vaccine, Rotarix - Infections, Rotavirus, Rotavirus Vaccines | Phase 3 | Completed | GlaxoSmithKline | 1612 | 2016-10-27 | 2020-07-21 |
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
Squarekids, Rotarix - Rotavirus | Phase 4 | Completed | GlaxoSmithKline | 292 | 2016-09-16 | 2019-11-25 |
Baby Vaccine Study (Sched3)
DTaP/IPV/Hib vaccine, 13 valent Pneumococcal Conjugate Vaccine, Rotavirus vaccine - Infectious Diseases | Phase 2 | Completed | University of Oxford | 189 | 2015-08-01 | 2021-09-20 |
Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
Infanrix hexa, Pediarix, ActHIB - Poliomyelitis, Diphtheria | Phase 3 | Completed | GlaxoSmithKline | 585 | 2014-04-16 | 2019-11-27 |
Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
Rotarix, RotaTeq - Rotavirus Vaccine | Phase 3 | Completed | National Institute of Pediatrics, Mexico | 1498 | 2013-11-01 | 2018-08-08 |
Immunogenicity of 1 or 2 Doses of bOPV in Chilean Infants Primed With IPV Vaccine
IPV, bOPV, mOPV type 2 - Polio | Phase 4 | Unknown | University of Chile | 570 | 2013-04-01 | 2014-05-20 |
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
Human Rotavirus Vaccine - Rotavirus Gastroenteritis | Phase 4 | Completed | PATH | 456 | 2012-09-01 | 2015-06-01 |
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
IPV (inactivated polio vaccine), Rotarix - Rotavirus Diarrhea, Vaccine Virus Shedding | Phase 3 | Completed | University of Vermont | 700 | 2011-05-01 | 2025-04-29 |
Immunogenicity of Rotavirus Vaccine
Rotavirus vaccine - Rotavirus Gastroenteritis | Phase 4 | Completed | PATH | 1140 | 2011-04-01 | 2013-08-30 |
Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Rotarix - Intestinal Failure, Rotavirus Vaccines | Phase 4 | Completed | Seattle Children's Hospital | 15 | 2009-12-01 | 2015-11-18 |
A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants
Rotarix - Diarrhea, Fever | Phase 2 | Completed | National Institute of Hygiene and Epidemiology, Vietnam | 200 | 2009-10-01 | 2016-07-04 |
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Conditions studied
Rotavirus Infections (10) · Gastroenteritis (6) · Pneumococcal Infections (5) · Diarrhea (3) · Streptococcal Infections (3) · Diphtheria (2) · Hepatitis B (2) · Poliomyelitis (2) · Tetanus (2) · Vomiting (2) · Acquired Immunodeficiency Syndrome (1) · Breast Feeding (1) · Communicable Diseases (1) · Fever (1) · Haemophilus Infections (1)
Sponsors
GlaxoSmithKline (18) · PATH (4) · Sanofi (2) · Centre for Infectious Disease Research in Zambia (1) · International Centre for Diarrhoeal Disease Research, Bangladesh (1) · National Institute of Hygiene and Epidemiology, Vietnam (1) · National Institute of Pediatrics, Mexico (1) · Seattle Children's Hospital (1) · Tanabe Pharma Corporation (1) · University of Chile (1) · University of Oxford (1) · University of Vermont (1)
Countries
United States (7) · Mexico (5) · South Africa (4) · Japan (3) · Bangladesh (2) · Chile (2) · Philippines (2) · Puerto Rico (2) · Taiwan (2) · Zambia (2) · Australia (1) · China (1) · Colombia (1) · Costa Rica (1) · Czechia (1)
Top investigators
George Armah, PhD (2) · Roma Chilengi, MD (2) · Anh D Dang, PhD. (1) · Beth Kirkpatrick, M.D. (1) · Desiree Witte, MD (1) · Janet Englund, MD (1) · K Zaman, MBBS, PhD (1) · Matthew D Snape (1) · Miguel L O'Ryan, MD (1) · Patrick J Javid, MD (1) · Rashidul Haque, M.D., Ph.D. (1) · S. Asad Ali, MBBS (1) · Simon Horslen, M.B., ChB (1)
Results publications
PMID 16394298, PMID 22520120, PMID 25278086, PMID 26035743, PMID 26318714, PMID 26643930, PMID 26823335, PMID 26870801, PMID 27154394, PMID 27217217, PMID 28079828, PMID 28293424, PMID 28419095, PMID 28425818, PMID 28444240, PMID 29390150, PMID 29394355, PMID 29514306, PMID 30376086, PMID 32035706, PMID 32157282, PMID 32867719, PMID 33109390, PMID 33245004, PMID 33428870, PMID 34454786, PMID 34565452, PMID 34788488, PMID 38463163, PMID 39052701, PMID 41319434, PMID 41495936
NIH funding
2015 (3), 2016 (3), 2014 (1)