Clinical trials: Safety Culture
Prophylaxis of A/H3N2v Influenza
Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.
Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly 65 years and older.
- Trial name
- NCT01855945
- Testing
- Swine Influenza
- Where
- 11 sites in United States
- Volunteers
- 627 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Influenza Disease; Flu
Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults
The purpose of this study is to evaluate the safety and immunogenicity of cell culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin vaccine administered to healthy adults ages 18 < 50 years.
- Trial name
- NCT00264576
- Testing
- Influenza Virus Vaccine
- Where
- 4 sites in United States
- Volunteers
- 613 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Influenza
A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications
The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18 years of age who are at risk of complications of influenza disease due to underlying diseases.
- Trial name
- NCT01998477
- Testing
- TIVc, TIV
- Where
- 16 sites in Italy, Spain
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Influenza
Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup
The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free…
- Trial name
- NCT00579345
- Testing
- Cell culture derived seasonal trivalent influenza vaccine (cTIV), Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)., cTIV or eTIV_a
- Where
- 5 sites in Poland
- Volunteers
- 1,522 people, healthy volunteers welcome
- Sponsor
- Novartis
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
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
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
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
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
Influenza
Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.
- Trial name
- NCT00630331
- Testing
- Cell culture-derived influenza vaccine, Egg-derived influenza virus vaccine
- Where
- 56 sites in United States, Finland and 1 more
- Volunteers
- 11,404 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV Infections
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day…
- Trial name
- NCT00390780
- Testing
- miconazole Lauriad, Clotrimazole
- Where
- 27 sites in United States, Canada
- Volunteers
- 578 people
- Sponsor
- Valerio Therapeutics
Influenza, Human, Influenza in Birds
A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed
This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89_18 in the <65 years of age cohort.
- Conditions
- Influenza, Human, Influenza in Birds, Respiratory Tract Infections, Infections
- Trial name
- NCT05422326
- Testing
- aH5N6c on Day 1, aH5N6c on Day 22
- Where
- 18 sites in United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Seqirus
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
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
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, Fever
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.
- Trial name
- NCT01857206
- Testing
- Mammalian cell based flu vaccine, Egg based flu vaccine
- Where
- 34 sites in United States, Australia and 3 more
- Volunteers
- 2,055 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
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.
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