Clinical trials: Adverse Reaction
- Condition Adverse Reaction
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Vaccine Adverse Reaction, Vaccine Reaction
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study.
- Trial name
- NCT06690515
- Testing
- DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B, Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®
- Where
- 3 sites in Indonesia
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
COVID-19, Vaccine Adverse Reaction
National Vaccine Adverse Event Reporting Survey and Etiology
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms.
- Conditions
- COVID-19, Vaccine Adverse Reaction, Vaccine Reaction, Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use
- Trial name
- NVAERS (NCT05095844)
- Testing
- vaccinated
- Where
- United States
- Volunteers
- 100,000 people
- Sponsor
- Neuroganics LLC
Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B…
- Conditions
- Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction, Haemophilus Influenzae Type B Vaccine Adverse Reaction
- Trial name
- NCT05482282
- Testing
- Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine, Recombinant Hepatitis B vaccine (Registered BioFarma)
- Where
- 3 sites in Indonesia
- Volunteers
- healthy volunteers welcome
- Sponsor
- PT Bio Farma
Drug Hypersensitivity
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin…
- Trial name
- NCT05269082
- Testing
- No intervention
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Takeda
SCAR
An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate
The reason for this study is to understand if people with certain genes are predisposed to develop severe skin reactions after they are administered Eslicarbazepine Acetate.
- Trial name
- NCT02520557
- Testing
- Blood or Saliva
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Sumitomo Pharma America, Inc.
Vaccine Reaction, Vaccine Adverse Reaction
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses…
- Trial name
- NCT05482295
- Testing
- In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Adverse Local Tissue Reaction, Total Hip Arthroplasty
ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.
- Trial name
- NCT01884532
- Testing
- ASR-XL Metal-on-Metal
- Where
- 7 sites in United States
- Volunteers
- 146 people
- Sponsor
- DePuy Orthopaedics
Allergic Rhinitis, Seasonal Allergic Rhinitis
Post Marketing Surveillance for Contac Bien Z in Japan
This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.
- Trial name
- NCT02020902
- Testing
- Cetrizine hydrochloride
- Where
- Japan
- Volunteers
- 1,552 people
- Sponsor
- GlaxoSmithKline
Serotonin Syndrome
Azilect + Antidepressant Chart Review
To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD…
- Trial name
- STACCATO (NCT00955604)
- Testing
- Group R+AD Rasagiline + Antidepressant, Group R Rasagiline, Group AD Anti-PD + Antidepressant
- Volunteers
- 1,500 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.
- Conditions
- Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions
- Trial name
- NCT01828801
- Testing
- Pinnacle Metal-on Metal
- Where
- 8 sites in United States
- Volunteers
- 276 people
- Sponsor
- DePuy Orthopaedics
Rabies Vaccine Adverse Reaction, Safety and Efficacy
A Clinical Trial of Freeze-dried Human Rabies Vaccine (Vero Cells)
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design.
- Trial name
- NCT04852068
- Testing
- Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program
- Where
- China
- Volunteers
- 2,480 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Drug Side Effects
Pharmacogenomics Registry to Assess Clinical Utility
The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects…
- Trial name
- PREACT (NCT02374840)
- Volunteers
- 340,778 people
- Sponsor
- Companion Dx Reference Lab, LLC
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Trial name
- NCT04770922
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cipherome, Inc.
Influenza
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the…
- Trial name
- NCT02567721
- Testing
- Vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 11,530 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic…
- Trial name
- NCT05137847
- Testing
- Remitoro
- Where
- 3 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Eisai Inc.
Injection Site Irritation, Injection Site Bruising
Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline
This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject.
- Conditions
- Injection Site Irritation, Injection Site Bruising, Injection Site Discomfort, Benzoic Acid Adverse Reaction
- Trial name
- NCT05109000
- Testing
- Sodium Chloride 0.9% Inj, Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jeffrey Alan Klein, MD
Vaccine Reaction, Vaccine Adverse Reaction
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
- Trial name
- NCT05546502
- Testing
- SARS-CoV-2 Protein Subunit Recombinant Vaccine, Active Comparator
- Where
- 10 sites in Indonesia
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Rabies Vaccine Adverse Reaction
A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2
- Trial name
- NCT06078423
- Testing
- Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program
- Where
- China
- Volunteers
- 1,880 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Adverse Reaction to Drug
Post-market Safety Reassessment of Ulinastatin for Injection
1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) 2.
- Trial name
- NCT02520570
- Testing
- ulinastatin
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.