32 completed, 1 unknown. 33 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 33 | Completed 32, Unknown 1 |
| Phase 2 | 1 | Completed 1 |
Follow Rotavirus Infections: new trials by email Literature Review of Rotavirus Infections trials Research Report on Rotavirus Infections
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 |
|---|---|---|---|---|---|---|
| Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine, Lyophilized formulation of GSK's oral live attenuated HRV vaccine - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 1351 | 2019-07-19 | 2022-03-10 |
| Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried), Placebo - Rotavirus Infection | Phase 3 | Completed | Limited Liability Company Pharm Aid | 100 | 2019-02-22 | 2021-09-05 |
| Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years. The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried), Placebo - Rotavirus Infections, Rotavirus Vaccines | Phase 3 | Completed | Limited Liability Company Pharm Aid | 40 | 2018-06-25 | 2021-09-08 |
| Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam ROTAVAC® - Rotavirus Infections | Phase 3 | Unknown | Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products | 360 | 2018-02-08 | 2019-03-25 |
| 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 |
| Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants GSK Biologicals' liquid human rotavirus vaccine 444563, Placebo, Infanrix™ - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 3340 | 2010-08-29 | 2018-08-06 |
| Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age Synflorix, Infanrix hexa, Rotarix - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 230 | 2007-09-18 | 2018-06-08 |
| Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants Rotarix, Placebo - Infections, Rotavirus, Rotavirus Vaccines | Phase 3 | Completed | GlaxoSmithKline | 765 | 2007-06-19 | 2020-01-02 |
| RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016) RotaTeq®, NeisVac-C® - Meningitis, Meningococcal, Rotavirus Infections | Phase 3 | Completed | Merck Sharp & Dohme LLC | 247 | 2007-02-13 | 2018-06-20 |
| Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine. Rotarix (primary vaccination study), Placebo (primary vaccination study) - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 1613 | 2007-02-12 | 2018-08-28 |
| To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants Rotarix™, Placebo - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 1009 | 2007-01-25 | 2018-06-08 |
| A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family. Rotarix, Placebo - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 200 | 2007-01-23 | 2018-02-06 |
| Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210) Rotarix™, Placebo - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 8687 | 2007-01-01 | 2016-12-09 |
| A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine). 2-dose oral live attenuated G1P[8] human rotavirus vaccine - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 1200 | 2006-11-01 | 2016-11-04 |
| To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants) Lyophilized formulation of HRV vaccine, Liquid formulation of HRV vaccine - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 1274 | 2006-09-01 | 2018-06-08 |
| Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines 10 valent pneumococcal conjugate vaccine, Infanrix Hexa, Rotarix - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 400 | 2006-09-01 | 2017-03-23 |
| To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam) Human rotavirus liquid vaccine - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 375 | 2006-09-01 | 2016-10-28 |
| Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA 2-dose oral live attenuated G1P[8] human rotavirus vaccine - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 484 | 2006-06-01 | 2016-11-04 |
| Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India Live attenuated human rotavirus vaccine - Infections, Rotavirus | Phase 3 | Completed | GlaxoSmithKline | 360 | 2006-02-10 | 2017-05-30 |
Showing 20 of 33. Sign in to see all of them.
Gastroenteritis (4) · Diarrhea (2) · Pneumococcal Infections (2) · Adenoviridae Infections (1) · Caliciviridae Infections (1) · Intussusception (1) · Meningitis, Meningococcal (1)
Infections (33) · RNA Virus Infections (33) · Reoviridae Infections (33) · Virus Diseases (33) · Digestive System Diseases (4) · Gastrointestinal Diseases (4) · Bacterial Infections (3) · Bacterial Infections and Mycoses (3) · Gram-Positive Bacterial Infections (2) · Pathological Conditions, Signs and Symptoms (2) · Signs and Symptoms (2) · Signs and Symptoms, Digestive (2) · Streptococcal Infections (2) · Central Nervous System Bacterial Infections (1) · Central Nervous System Diseases (1)
RIX4414 vaccine (11) · Rotavirus Vaccines (7) · RotaTeq (4) · Freeze Drying (2) · diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine (2) · 10-valent pneumococcal conjugate vaccine (1) · 13-valent pneumococcal vaccine (1) · Acetaminophen (1) · Acetylglucosaminidase (1) · CRM197 (non-toxic variant of diphtheria toxin) (1) · Diphtheria-Tetanus-acellular Pertussis Vaccines (1) · Hepatitis B Vaccines (1) · Hiberix (1) · PEDIARIX (1) · PHiD-CV vaccine (1)
GlaxoSmithKline (23) · Merck Sharp & Dohme LLC (6) · Limited Liability Company Pharm Aid (2) · Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products (1) · Romark Laboratories L.C. (1)
Finland (5) · United States (4) · Colombia (3) · Dominican Republic (3) · Panama (3) · Spain (3) · Taiwan (3) · Argentina (2) · Brazil (2) · Czechia (2) · France (2) · Germany (2) · Honduras (2) · Japan (2) · Mexico (2)
Irina V. Feldblium, Dr. Sci (1) · Irina V. Feldblium, PhD (1) · Mona Abu-Zekry, MD (1) · Olga A. Rychkova, Dr. Sci (1)
PMID 16394298, PMID 16394299, PMID 16829296, PMID 18756184, PMID 19209092, PMID 20540778, PMID 21238572, PMID 21323176, PMID 21389149, PMID 22974466, PMID 23807360, PMID 24013441, PMID 27895844, PMID 29564996, PMID 34788488
2016 (2), 2015 (1), 2018 (1)