Clinical trials: Safety Culture
Influenza
Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy…
- Trial name
- NCT00306527
- Testing
- Cell culture derived influenza vaccine, egg-derived influenza subunit vaccine
- Where
- 5 sites in Poland
- Volunteers
- 2,235 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Pandemic H5N1 Influenza
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
- Trial name
- NCT01776554
- Testing
- Adjuvanted H5N1 pandemic influenza vaccine
- Where
- 12 sites in United States, Thailand
- Volunteers
- 662 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Pandemic H5N1 Influenza
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.
- Trial name
- NCT01776541
- Testing
- Adjuvanted H5N1 pandemic influenza vaccine
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 979 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Pandemic H5N1 Influenza
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects
- Trial name
- NCT01766921
- Testing
- Adjuvanted H5N1 pandemic influenza vaccine
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 1,393 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Influenza
Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above
The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly subjects and the antibody response to each…
- Trial name
- NCT01640314
- Testing
- Cell derived subunit trivalent nonadjuvanted vaccine
- Where
- Germany
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Avian Influenza
A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797…
- Trial name
- NCT02839330
- Testing
- aH5N1c
- Where
- 26 sites in United States
- Volunteers
- 3,196 people, healthy volunteers welcome
- Sponsor
- Seqirus
Seasonal Influenza Vaccine
Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008
Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects
- Trial name
- NCT00511914
- Testing
- cTIV
- Where
- 2 sites in Germany
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Onychomycosis of Toenails
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
- Trial name
- NCT01302119
- Testing
- AN2690 Topical Solution, 5%, Solution Vehicle
- Where
- 32 sites in United States, Canada
- Volunteers
- 604 people
- Sponsor
- Pfizer
COVID-19
Coronavirus Disease of 2019 (COVID-19) Health Education Initiative for School Safety
The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not.
- Trial name
- NCT06938230
- Testing
- Health Education Initiative
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- University of Miami
Onychomycosis of Toenails
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
- Trial name
- NCT01270971
- Testing
- AN2690 Topical Solution, 5%, Solution Vehicle
- Where
- 27 sites in United States
- Volunteers
- 594 people
- Sponsor
- Pfizer
Human Influenza
Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvanted Influenza Study Vaccine in Adults Aged 18 Years and Above
The present study is designed to confirm the safety and immunogenicity of cell-derived, trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody response to each…
- Trial name
- NCT01880697
- Testing
- TIVc
- Where
- Germany
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Influenza
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.
- Trial name
- NCT00492063
- Testing
- Cell culture-derived trivalent subunit influenza vaccine (cTIV), Egg-derived trivalent subunit influenza vaccine (TIV)
- Where
- 5 sites in Poland
- Volunteers
- 2,654 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Chronic Kidney Diseases, Apolipoprotein L1
APOL1 Genetic Testing Program for Living Donors
Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves.
- Conditions
- Chronic Kidney Diseases, Apolipoprotein L1, Kidney Transplantation
- Trial name
- NCT04910867
- Testing
- Components of Genetic Counseling, APOL1 genetic testing, EHR integration
- Where
- 2 sites in United States
- Volunteers
- 280 people
- Sponsor
- Northwestern University
Pulmonary Tuberculosis
Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.
- Trial name
- NCT01498419
- Testing
- Moxifloxacin (M), Pretomid (Pa), Pyrazinamide (Z)
- Where
- 8 sites in South Africa, Tanzania
- Volunteers
- 207 people
- Sponsor
- Global Alliance for TB Drug Development
Influenza
Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents
The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years.
- Trial name
- NCT00645411
- Testing
- Cell culture-derived influenza subunit vaccine (cTIV), Egg derived influenza subunit vaccine (eTIV)
- Where
- 60 sites in United States, Croatia and 5 more
- Volunteers
- 3,604 people, healthy volunteers welcome
- Sponsor
- Novartis
Influenza
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
The purpose of the study is to compare the safety of \& immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix]…
- Trial name
- NCT00693706
- Testing
- Trivalent influenza vaccine GSK 138842A, Fluarix
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Multidrug-resistant Tuberculosis
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.
- Trial name
- NCT01424670
- Testing
- Delamanid + OBR
- Where
- 17 sites in Estonia, Latvia and 5 more
- Volunteers
- 511 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Influenza
Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)
The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine…
- Trial name
- NCT00310804
- Testing
- Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)
- Where
- 2 sites in Lithuania
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Influenza
Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects
All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.
- Trial name
- NCT02467842
- Testing
- NBP607-QIV, NBP607-Y, NBP607-V
- Volunteers
- 1,503 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.