Clinical trials: Human
Influenza
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when influenza is circulating in the community…
- Trial name
- NCT00412555
- Testing
- oseltamivir [Tamiflu]
- Where
- 6 sites in United States, Canada and 1 more
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pompe Disease Late-Onset, Glycogen Storage Disease Type II GSD II
Extension Study of Long-term Safety and Efficacy of Myozyme for a Single Patient With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored ERT Studies.
This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a Genzyme study.
- Trial name
- NCT00765414
- Testing
- Myozyme
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Genzyme, a Sanofi Company
Influenza
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir.
- Trial name
- NCT00949533
- Testing
- Oseltamivir
- Where
- 3 sites in Brazil
- Volunteers
- 37 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 1
Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.
- Trial name
- NCT00479258
- Testing
- Inhaled insulin (Exubera), Subcutaneous Insulin (subject's prescribed)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Pfizer
Clostridium Difficile Infection
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument.
- Trial name
- NCT02968758
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 7 sites in United States, Canada
- Volunteers
- 2,461 people
- Sponsor
- Meridian Bioscience, Inc.
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Influenza
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.
- Trial name
- NCT02242643
- Testing
- FluLaval™ Quadrivalent, Fluzone® Quadrivalent
- Where
- 66 sites in United States, Mexico
- Volunteers
- 2,432 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Congenital Fibrinogen Deficiency
An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT02427217
- Testing
- FCH
- Where
- 11 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- CSL Behring
Influenza
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.
- Trial name
- NCT00971321
- Testing
- Pandemic influenza vaccine GSK2340272A
- Where
- 5 sites in Spain
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Novel 2009 Influenza H1N1, Influenza, Human
Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents
This is a single-blind, reference drug controlled study to assess safety and tolerability of FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL…
- Trial name
- NCT01407978
- Testing
- Vaccination with Fluval P monovalent influenza vaccine, Vaccination with Fluval AB, Vaccination with Fluval AB Novo
- Where
- Hungary
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Fluart Innovative Vaccine Ltd, Hungary
Influenza Human
Clinical Validation of the Point-of-Care MSD Influenza Test
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT00863343
- Testing
- Public Health Notification
- Where
- 3 sites in United States
- Volunteers
- 391 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Hepatitis B, Polio
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00315055
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6…
- Trial name
- NCT04381689
- Testing
- IL-YANG FLU Vaccine Prefilled Syringe INJ., Fluarix Tetra Pre-filled Syringe
- Where
- 2 sites in South Korea
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Acellular Pertussis, Diphtheria
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib…
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b
- Trial name
- NCT00627458
- Testing
- Infanrix Hexa
- Where
- 6 sites in Finland
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Human Myopia Model
Clinical Research Plan for Human Myopia Models
Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.
- Trial name
- NCT06185868
- Testing
- No intervention measures
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Robotrak Technologies Co., Ltd.
HIV Infections
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced…
- Trial name
- NCT00232908
- Testing
- ARV regimen, enfuvirtide [Fuzeon]
- Where
- 106 sites in United States, Puerto Rico
- Volunteers
- 361 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
- Trial name
- NCT00423891
- Testing
- Entecavir
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 64 people
- Sponsor
- Bristol-Myers Squibb
Hemophilia A
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts.
- Trial name
- NCT00157040
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 50 people
- Sponsor
- Baxalta now part of Shire