Clinical trials: Agreement
Hepatitis A
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A…
- Trial name
- NCT00289757
- Testing
- Havrix™
- Where
- Belgium
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza, Human
Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over…
- Trial name
- NCT02663102
- Testing
- Data collection
- Where
- 21 sites in South Korea
- Volunteers
- 1,388 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV
A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines
Treatment of children and infants with HIV requires modification of medication dosing according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line treatment option that is increasingly necessary due to…
- Trial name
- NCT01172535
- Testing
- Lopinavir/ritonavir
- Where
- 19 sites in United States, Brazil and 2 more
- Volunteers
- 97 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Papillomavirus Infection Leading to Cervical Cancer
A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.
The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of…
- Trial name
- NCT00730847
- Testing
- Cervarix
- Where
- 2 sites in Philippines
- Volunteers
- 743 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Renal Interstitial Fibrosis
Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them de novo expression of vimentin by tubular epithelial cells, which is an intermediate filament, and the translocation of beta-catenin…
- Trial name
- CERTITEM (NCT01079143)
- Testing
- Certican®, Neoral, Myfortic
- Where
- 23 sites in France
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
Influenza
Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.
- Trial name
- NCT01631110
- Testing
- Inflexal V
- Where
- Switzerland
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Hyperlipidemia
Compliance With Treatment For Patients With Hyperlipidemia
It is a prospective observational study. Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin.
- Trial name
- COLL (NCT00828945)
- Testing
- Lipid Self Test
- Where
- 17 sites in Sweden
- Volunteers
- 259 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Patients With an Indication for an ICD Implantation According to the Guidelines
Protecta Smart Analysis Register
ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent…
- Trial name
- ProSA (NCT01714921)
- Volunteers
- 504 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Infections, Papillomavirus
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or…
- Trial name
- NCT01462357
- Testing
- Cervarix, Gardasil
- Where
- 21 sites in France, Hong Kong and 2 more
- Volunteers
- 1,079 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Critical Illness, Chronic Disease
Improving Communication About Serious Illness
The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting.
- Conditions
- Critical Illness, Chronic Disease, Terminal Care, Palliative Care
- Trial name
- ICSI (NCT01933789)
- Testing
- Communication Feedback Form for Patients with Serious Illness
- Where
- 6 sites in United States
- Volunteers
- 817 people
- Sponsor
- University of Washington
Corona Virus Infection
Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.
- Trial name
- NCT04780581
- Testing
- Dexamethasone, Methylprednisolone
- Where
- 4 sites in Spain
- Volunteers
- 128 people
- Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Transplantation Infection
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients…
- Trial name
- EVEREST (NCT01276457)
- Testing
- Everolimus 0.25 and 0.75 mg tablets, Cyclosporine very low dose (150-300 ng/mL) microemulsion, Cyclosporine low dose (350-500 ng/mL) microemulsion
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients
This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending…
- Trial name
- NCT00432172
- Testing
- Epirubicin, Cyclophosphamide, Docetaxel
- Where
- 12 sites in Spain
- Volunteers
- 189 people
- Sponsor
- Spanish Breast Cancer Research Group
Clostridium Infections
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a…
- Trial name
- NCT04026009
- Testing
- C. difficile investigational vaccine based on the F2 antigen (GSK2904545A), C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Advanced Metastatic Cancer, Advanced Prostate Cancer
Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer
This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors.
- Trial name
- NCT03651271
- Testing
- Nivolumab Monotherapy, Nivolumab and Ipilimumab and Combination for Metastatic Cancer, Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Parker Institute for Cancer Immunotherapy
Anemia, Neoplasms
An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)
This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia.
- Trial name
- NCT01168349
- Testing
- epoetin beta [NeoRecormon]
- Where
- France
- Volunteers
- 1,060 people
- Sponsor
- Hoffmann-La Roche
Infections, Papillomavirus
Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women.
- Trial name
- NCT00345878
- Testing
- HPV-16/18 L1 VLP AS04 (Cervarix TM)
- Where
- 2 sites in Malaysia
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Apical Periodontitis, Pulp Disease, Dental
In-Vivo Diagnostic Accuracy and Repeatability of Root ZX3 for Working-Length Determination in Single-Rooted Teeth: Agreement With CBCT and Microscopic Validation
This study evaluated the accuracy and repeatability of the Root ZX3 electronic apex locator for working-length determination in 77 single-rooted permanent teeth.
- Conditions
- Apical Periodontitis, Pulp Disease, Dental, Device Reliability, Device Performance
- Trial name
- NCT07689838
- Testing
- Root ZX3 Electronic Apex Locator
- Where
- Saudi Arabia
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Riyadh Elm University
Hepatitis A
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A…
- Trial name
- NCT00291876
- Testing
- Havrix™
- Where
- Belgium
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal…
- Trial name
- NCT01229397
- Testing
- Inflexal V
- Where
- 2 sites in Italy
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV