Clinical trials: Safety Culture
- Condition Safety Culture
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Swine-Origin Influenza A H1N1 Virus
Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.
- Trial name
- NCT01098786
- Testing
- Cell-derived A/H1N1 influenza HA vaccine
- Where
- Japan
- Volunteers
- 556 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Influenza, Human
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents
This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the trivalent cell culture-derived influenza vaccine compared to the trivalent…
- Trial name
- NCT02621177
- Testing
- NBP607, Agrippal S1
- Volunteers
- 385 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Japanese Encephalitis
Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj.
- Trial name
- BR-JELITE (NCT02532569)
- Testing
- Japanese encephalitis vaccine
- Where
- 9 sites in South Korea
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Influenza, Human
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the…
- Trial name
- NCT02621164
- Testing
- NBP607-QIV, Agrippal S1
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Influenza, Human, Pregnancy
Flucelvax (TIVc or QIVc) Pregnancy Registry
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy.
- Conditions
- Influenza, Human, Pregnancy, Birth Defect
- Trial name
- NCT03438487
- Testing
- Flucelvax Trivalent Influenza Vaccine, Flucelvax Quadrivalent Influenza Vaccine
- Where
- United States
- Volunteers
- 692 people, healthy volunteers welcome
- Sponsor
- Seqirus
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
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
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
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, Human
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months
This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the…
- Trial name
- NCT03020628
- Testing
- NBP607-QIV, NBP607-TIV
- Where
- 12 sites in South Korea
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Influenza
Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months
This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.
- Trial name
- NCT03704740
- Testing
- NBP607-QIV, Agrippal
- Where
- South Korea
- Volunteers
- 676 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
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, 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
Novel Influenza A (H1N1), A New Flu Virus of Swine Origin
Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and…
- Trial name
- NCT01037855
- Testing
- Non-intervention observational study
- Where
- 10 sites in Chile, Colombia and 2 more
- Volunteers
- 4,028 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines