Clinical trials: Biologic
Influenza
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.
- Trial name
- NCT01974895
- Testing
- FluLaval® Quadrivalent, Fluzone®
- Where
- 12 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neuroblastoma
Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Inserting genetic material made in the laboratory into a person's blood cells may make the body build an immune…
- Trial name
- NCT00006480
- Testing
- aldesleukin, therapeutic autologous lymphocytes, chemotherapy
- Where
- 2 sites in United States
- Sponsor
- Fred Hutchinson Cancer Center
Hepatitis B
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
- Trial name
- NCT00383227
- Testing
- Hepatitis B adjuvanted vaccine
- Volunteers
- 165 people
- Sponsor
- GlaxoSmithKline
Asthma
Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze
Cross-sectional study to characterize cohorts of children with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for…
- Trial name
- NCT01982162
- Volunteers
- 300 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Normal and Diseased Tissue and Body Fluids Samples
Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St.
- Trial name
- NCT01354002
- Where
- 14 sites in United States
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- St. Jude Children's Research Hospital
Children With Autism
Heterogeneity in ASD: Biological Mechanisms, Trajectories, and Treatment Response
Parent-mediated interventions often target social communication in young children with ASD, although to date studies yield inconsistent effects.
- Trial name
- NCT03253081
- Testing
- PARENT focused intervention, CHILD focused intervention
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- University of California, Los Angeles
Implant Complication
Prosthetic and Biological Complications of Implant Supported Prostheses
complications of implant retained prostheses
- Trial name
- NCT05297253
- Testing
- telescopic overdenture
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Research Centre, Egypt
Diphtheria, Tetanus
Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old…
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT01988857
- Testing
- Boostrix™
- Where
- Vietnam
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either…
- Trial name
- NCT00370396
- Testing
- Synflorix, Prevenar, Infanrix hexa
- Where
- 35 sites in Finland, France and 1 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Vaccine
Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive"
Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI…
- Trial name
- NCT05715918
- Testing
- Vaccine for intramuscular injection
- Where
- 4 sites in Russia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Inflammatory Bowel Diseases, Crohn Disease
Exploration of the Activity of DNA Located Outside of Cellular Nucleus to Amplify Inflammation in Inflammatory Bowel Disease in Children Through Biological Pathway Cyclic GMP-AMP Synthase (cGAS) - Stimulator of Interferon Genes (STING)
Frequency of Inflammatory Bowel Diseases in children (IBD)-Crohn's disease (CD), Ulcerative colitis (UC) is constantly increasing.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Trial name
- ROXANE (NCT05916274)
- Testing
- Blood and fecal samples, Coolonic biopsies
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Régional d'Orléans
Autism Spectrum Disorders, Mood Disorders
Multidimensional Measurement of Psychopharmacological Treatment Response
The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.
- Conditions
- Autism Spectrum Disorders, Mood Disorders, Sleep Disorders, Attention Deficit Disorders
- Trial name
- NCT01184235
- Testing
- Pharmacological Intervention
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Child Psychopharmacology Institute
Systemic Lupus Erythematosus of Childhood
Interferon Pathway Activation in Monogenic and Nonmonogenic Forms of Pediatric SLE
Pediatric SLE includes monogenic forms, some of which involve the interferon type I (IFN-I) pathway. The IFN-I pathway is renally active in adult SLE and correlates with the extent of renal damage.
- Trial name
- NCT06586710
- Testing
- Assessment activation of interferon pathway
- Where
- 3 sites in Italy
- Volunteers
- 60 people
- Sponsor
- Meyer Children's Hospital IRCCS
Diffuse Intrinsic Pontine Glioma, PNET
Exploratory Study of Effects of Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
This study will analyze the effects of radiation given to children who have tumors of the central nervous system (CNS). Researchers want to learn more about changes in the quality of life that patients may experience as a result…
- Conditions
- Diffuse Intrinsic Pontine Glioma, PNET, Ependymoma, Germinoma
- Trial name
- NCT01445288
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- National Cancer Institute (NCI)
Cystinosis
Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis
The purpose of this study is to determine the molecular mechanism of this disease and to research the relationship between cystinosis and skin phenotype.
- Trial name
- NCT00822250
- Testing
- analysis of pigmentation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Stress
Psychobiological Responses to Choral Singing in Mentally Ill and Healthy Children and Adolescents
Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test design, controlled, parallel group study to investigate the effects of a group singing intervention on neuroendocrine (hair cortisol…
- Trial name
- NCT04454736
- Testing
- "Amateur" Group Singing, "Professional" Group Singing
- Where
- 3 sites in Austria
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- University of Salzburg
Infections, Rotavirus
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh
The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).
- Trial name
- NCT00139334
- Testing
- Rotavirus
- Where
- Bangladesh
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
- Trial name
- NCT00429481
- Testing
- Rotarix
- Volunteers
- 2,464 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline