Clinical trials: H1N1/Influenza Infection
Influenza
Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom
The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, communication and evaluation…
- Trial name
- H1N1 PASS UK (NCT00996853)
- Testing
- Safety follow up
- Where
- 91 sites in United Kingdom
- Volunteers
- 9,206 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Sinovac, H1N1 Vaccine + Trivalent Inactivated Influenza Vaccine, Adults
A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with…
- Trial name
- NCT01008137
- Testing
- H1N1 influenza A Vaccine (PANFLU.1), Trivalent Inactivated Influenza Vaccine (ANFLU)
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
H1N1 Influenza Treatment During Pregnancy
A Study of the Pharmacology of Tamiflu in Pregnancy
The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect the currently recommended dosage of this medication.
- Trial name
- NCT01203527
- Where
- 4 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Influenza
Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?
Since the onset of the 2009 pandemic, several observational public health investigations in Canada have identified evidence that suggests that adults, particularly younger adults, who have previously received seasonal influenza…
- Trial name
- NCT01001325
- Testing
- Fluviral influenza vaccine, 2009-2010, Normal saline
- Where
- 2 sites in Canada
- Volunteers
- 468 people, healthy volunteers welcome
- Sponsor
- Mount Sinai Hospital, Canada
Influenza, Human
A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection
This study will be an open-label, multi-center, single arm study to evaluate the safety and efficacy of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with laboratory confirmed influenza infection.
- Trial name
- NCT01527110
- Testing
- Intravenous (IV) zanamivir
- Where
- 7 sites in Japan
- Volunteers
- 21 people
- Sponsor
- GlaxoSmithKline
Avian Influenza, H1N1 Influenza
H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses
This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years old, inclusive, designed to evaluate and…
- Conditions
- Avian Influenza, H1N1 Influenza, Influenza
- Trial name
- NCT02921997
- Testing
- AS03, Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203, Monovalent influenza A/H7N9 virus vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels
The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine.
- Trial name
- NCT00944073
- Testing
- Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
- Where
- 9 sites in United States
- Volunteers
- 583 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Novel Influenza A, H1N1
Novel Influenza A (H1N1) Surveillance Registry
The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically.
- Conditions
- Novel Influenza A, H1N1, Influenza
- Trial name
- NCT01046331
- Where
- 86 sites in United States
- Volunteers
- 894 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Influenza
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
- Trial name
- NCT00996307
- Testing
- MF59-eH1N1_f
- Where
- 29 sites in United States, Mexico
- Volunteers
- 654 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Influenza
Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese…
- Trial name
- NCT01114620
- Testing
- Arepanrix™
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Drug Use Investigation for Arepanrix® (H1N1)
This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection.
- Trial name
- NCT02069496
- Testing
- Arepanrix®
- Volunteers
- 3,405 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies
The purpose of this study is to evaluate specific approaches used to prevent/reduce influenza transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, including assessing infection control strategies used…
- Trial name
- NCT01270685
- Where
- United States
- Sponsor
- US Department of Veterans Affairs
Influenza, Pneumonia
Effectiveness of H1N1 Influenza Vaccines in Manitoba, Canada
Excellent immune responses following 1 or 2 doses of the GSK monovalent AS03-adjuvanted pandemic H1N1 (pH1N1) vaccines (e.g., Arepanrix®) have been documented in several trials.
- Trial name
- NCT01622491
- Where
- Canada
- Volunteers
- 1,860 people
- Sponsor
- International Centre for Infectious Diseases, Canada
Influenza
Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications
Seasonal influenza is responsible for many hospitalizations and deaths each year, despite effective antiviral treatments. Some individuals have medical conditions such as heart or lung diseases that make them particularly at risk…
- Trial name
- IRC003 (NCT01227967)
- Testing
- Amantadine, Ribavirin, Oseltamivir, Oseltamivir
- Where
- 91 sites in United States, Argentina and 3 more
- Volunteers
- 881 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations.
- Trial name
- NCT00943631
- Testing
- Inactivated H1N1 Vaccine
- Where
- 3 sites in United States
- Volunteers
- 406 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
- Trial name
- NCT00979602
- Testing
- GSK2340274A, GSK2340273A
- Where
- 38 sites in United States, Canada
- Volunteers
- 4,048 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza, Human
Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection.
- Trial name
- NCT01369862
- Testing
- GHB16L2
- Where
- Austria
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AVIR Green Hills Biotechnology AG
Influenza, Swine-origin A/H1N1 Influenza
A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3 to 17 Years
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
- Trial name
- NCT00956202
- Testing
- Swine A/H1N1 influenza vaccine (split virion, inactivated), Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
- Where
- 15 sites in Finland
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Upper Respiratory Tract Infection, Influenza
A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection
To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.
- Trial name
- NCT00979667
- Testing
- Oseltamivir, Zanamivir
- Where
- 3 sites in China, Hong Kong
- Volunteers
- 4 people
- Sponsor
- Chinese University of Hong Kong
H1N1 Influenza
H1N1 Vaccine Safety in Manitoba, Canada
Many people worldwide received the monovalent adjuvanted H1N1 vaccine. However, very little is known about the safety of the vaccine, particularly beyond the first few weeks after vaccination.
- Trial name
- NCT01421251
- Where
- Canada
- Volunteers
- 800,000 people
- Sponsor
- International Centre for Infectious Diseases, Canada