Clinical trials: System Safety
Meningococcal Disease, Meningitis
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.
- Trial name
- NCT01430611
- Testing
- Meningococcal (Groups A and C) Polysaccharide Vaccine
- Where
- 2 sites in China
- Volunteers
- 666 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Poliomyelitis
Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults
The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that contains the 3 serotypes of polio).
- Trial name
- IPV-004 (NCT01997632)
- Testing
- a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD), a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).
- Where
- Belgium
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
Poliomyelitis, Tetanus
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Hepatitis B
- Trial name
- NCT00352963
- Testing
- Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
- Where
- 22 sites in Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C
TD-6450 SAD and MAD in Healthy Subjects
This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.
- Trial name
- NCT02022306
- Testing
- TD-6450
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
HIV Infections, Pneumococcal Infections
Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children
Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV infected children. The purpose of this study is to determine the safety of and immune response to a pneumococcal polysaccharide-protein…
- Trial name
- NCT00099658
- Testing
- Pneumococcal polysaccharide-protein conjugate vaccine
- Volunteers
- 579 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
Human Immunodeficiency Virus (HIV) Infection
Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.
- Trial name
- NCT00821535
- Testing
- maraviroc (Selzentry, Celsentri)
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Systemic Lupus Erythematosus
Japanese phase1 Study of Belimumab (IV vs SC)
This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous…
- Trial name
- NCT01516450
- Testing
- GSK1550188 IV, GSK1550188 SC
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections, Hepatitis B
Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People
The purpose of the study is to determine the safety of and immune response to a hepatitis B virus vaccine series given with a boosting agent, CpG7909 oligodeoxynucleotides (ODN), in HIV infected and HIV uninfected individuals who…
- Trial name
- NCT00100633
- Testing
- CpG7909 oligodeoxynucleotides (ODN), Hepatitis B virus vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer
Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants
The primary objective of the study is to evaluate the safety and tolerability of single- and multiple-ascending oral doses of BIIB095 in healthy participants.
- Trial name
- NCT03454126
- Testing
- BIIB095
- Where
- 2 sites in United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Dysphagia
To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
This study is a confirmation study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders.
- Trial name
- NCT03670485
- Testing
- 4 channel Electrical Stimulation Device
- Where
- South Korea
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Diabetes Mellitus
To Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699（Antidiabetic） in Healthy Chinese Sbjects
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multi-dose, sequential, bridging study in healthy volunteer using YG1699 .
- Trial name
- NCT05089617
- Testing
- YG1699
- Where
- China
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Youngene Therapeutics Inc., Ltd.
Hepatitis B Infection
A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process.
- Trial name
- NCT00489099
- Testing
- V232 Modified Process Hepatitis B Vaccine: Lot A, V232 Modified Process Hepatitis B Vaccine: Lot B, V232 Modified Process Hepatitis B Vaccine: Lot C
- Volunteers
- 860 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02752906
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Multiple Myeloma, Refractory
Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma
Immunotherapy has shown promise in the treatment of hematological malignancies, including multiple myeloma. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific…
- Trial name
- NCT06242249
- Testing
- Anti-BCMA CAR-NK
- Where
- Iran
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Shahid Beheshti University of Medical Sciences
Diabetes Mellitus, Type 2
A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus
20 eligible subjects will be enrolled into the treatment phase of the trial.
- Trial name
- NCT00642538
- Testing
- MKC253 Inhalation Powder, Technosphere Inhalation Powder, subcutaneous injection
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mannkind Corporation
Heart Diseases
IntraCardiac Echocardiography sysTem
To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co., Ltd.
- Trial name
- DISTINCT (NCT06392243)
- Testing
- Intracardiac ultrasound imaging system
- Where
- China
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Sonosemi Medical Co., Ltd.
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or…
- Trial name
- NCT04212091
- Testing
- PGT121.414.LS, VRC07-523LS
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diabetes, Diabetes Mellitus, Type 2
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial…
- Trial name
- NCT01809184
- Testing
- insulin 287, insulin glargine
- Where
- Germany
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Venezuelan Equine Encephalitis
Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine
This study is being done to determine the safety and tolerability of a new investigational vaccine referred to as VEE IA/B V3526, which may induce production of specific antibodies in vaccinated humans, and may protect them…
- Trial name
- NCT00109304
- Testing
- VEE 3526
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Short Bowel Syndrome, Parenteral Nutrition Associated Liver Disease
Study of NST-6179 in Healthy Subjects
A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.
- Trial name
- NCT05181085
- Testing
- NST 6179
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- NorthSea Therapeutics B.V.
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