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A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

Donor feces infusion for first episode of Clostridium difficile infection in patients at risk for recurrent infection

The primary objective of this study is to investigate whether FMT after antibiotic therapy is more effective than conventionalantibiotic therapy alone in patients with a first episode of CDI.

Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)

The primary objective of the study is to evaluate the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hemotopoietic cell transplants (HCTs).

A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old men.

This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…

A Phase 3, Open-label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years and Older

Primary Objective: *To evaluate the immune responses 1 month after 3 doses of 13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in subjects *2 years of age. Secondary Objectives: *To…

An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension

The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…

An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured with recombinant Human Albumin (rHA) when administered to Children in their Second Year of Life

To describe the safety profile of a second dose of ProQuad® manufactured with rHA when administered to children in their second year of life.

An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of a 1-dose regimen and different 2-dose regimens of a Zoster vaccine (Live), ZOSTAVAX, in subjects >= 70 years of age

Primary objectivesImmunogenicityTo demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects…

Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older

To demonstrate that QIV-HD induces an immune response that is superior to the responses induced by QIV-SD for all 4 virus strains 28 days post-vaccination in subjects 60 to 64 years of age and in subjects 65 years of age and older.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

Primary:- To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia.Secondary:- To evaluate the safety of a single IV dose of suvratoxumab.- To evaluate the effect of suvratoxumab on reducing the incidence of…

PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment

Primary objectiveTo assess whether prevention of aspiration, infections, and fever with metoclopramide, ceftriaxone, paracetamol, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly…

A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE IN HEALTHY
PARTICIPANTS >=5 YEARS OF AGE

This study has been transitioned to CTIS with ID 2023-509105-72-00 check the CTIS register for the current data. * To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary…

Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates.

This study has been transitioned to CTIS with ID 2024-518498-32-01 check the CTIS register for the current data. The project*s overarching aim is to diminish respiratory disease burden in moderate-late preterm born infants in their first year of…

Treatment of chemo-refractory viral infections after allogeneic
stem cell transplantation with multispecific T cells against CMV, EBV and
AdV: A phase III, prospective, multicentre clinical trial

This study has been transitioned to CTIS with ID 2024-512321-84-00 check the CTIS register for the current data. Primary objectives:Evaluation of efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after…

A phase 3 study to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus (RSV) prefusion F subunit vaccine in adults

ObjectivesPrimary Efficacy:To demonstrate the efficacy of RSVpreF in preventing LRTI-RSV in the first RSV season following vaccination.Primary Safety:To describe the safety profile of RSVpreF as measured by the percentage of participants reporting…

Reducing health care workers absenteeism in SARS-CoV-2 pandemic by enhanced trained immune responses through Bacillus Calmette-Guérin vaccination, a randomized controlled trial.

Primary objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of COVID19. Secondary objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic…

BCG vaccination to Reduce the impact of COVID-19 in healthcare workers (BRACE) Trial

Primary objectives1. To determine if BCG vaccination (Intervention) compared with placebo (Comparator) reduces the incidence of COVID-19 disease (Outcome) measured over the 6 months following randomisation (Time) in healthcare workers exposed to…

Prevention of severe infectious complications after colorectal surgery using antimicrobial decontamination of the digestive tract

To determine the effect of Pre-OP, in addition to perioperative intravenous antimicrobial prophylaxis on the cumulative incidence of deep surgical site infections (SSI) and/or mortality within 30 days after surgery in patients undergoing elective…