interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44339
clinical trials with a EudraCT protocol, of which
7369
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI) ...
Medical condition: Age-Associated Memory Impairment (AAMI)
Full Title: Phase III, multi-center trial in 795 infants in the Czech Republic, Germany, and Spain. Subjects from the Czech Republic and Germany will be randomized in Groups 1 and 2 to receive in a blind-obser...
Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus in...
Full Title: A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of Infanrix hexa? administered as primary vaccination in healthy infants born to mothers given Boo...
Medical condition: Healthy volunteers [Primary immunisation of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)].
Full Title: A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa? in healthy infants born to mothers vaccinated with Boostrix? d...
Medical condition: Infanrix Hexa is indicated for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib).
Full Title: Phase III, randomized, blind-observer, single-center, controlled trial of the DTaP-IPV-Hep B-PRP-T vaccine in 266 healthy Peruvian infants.
Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus i...
Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.Clinical Research & Development Department
Full Title: A Randomized, Open-label, Comparative Evaluation of Conversion from Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipi...
Medical condition: Liver allograft recipients under maintenance therapy
Disease:
Population Age: Adolescents, Under 18, Adults, Elderly
Full Title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of...
Medical condition: Adult patients with moderate to severe chronic plaque psoriasis
-- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosp...
Full Title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Given as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and in HIV-Exposed Uninfected In...
Medical condition: DTaP-IPV-HB-PRP-T Combined Vaccine in Human Immunodeficiency Virus Exposed Infected and Uninfected Infants
Full Title: Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11...
Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus in...
Full Title: Study to compare immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose presentation to the licensed Synflorix™ (10Pn-PD-DiT) vaccine when co-administered with DTPw-combination vaccine in healthy in...
Full Title: A Phase III, randomized, blind-observer, controlled, multicenter trial in 412 infants in Thailand.
Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus i...
Full Title: Mono-center, open-label, randomized, active-controlled trial in 310 infants
Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus i...
Full Title: Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination with Investigational (DTaP-IPV-HB-Hib) or Infanrix™ hexa vaccines in ...
Medical condition: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilius Influenzae Type b
Sponsor Name:European Organisation for Research and Treatment of Cancer
Full Title: Primary chemotherapy with temozolomide vs. radiotherapy in patients with low grade gliomas after stratification for genetic 1p loss: a phase III study
Medical condition: Histologically proven low-grade glioma
♦ Astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic)
♦ Oligoastrocytoma WHO grade II
♦ Oligodendroglioma WHO grade II
Full Title: Clinical Otitis Media and Pneumonia Study (COMPAS): a phase III , double-blind, randomized, controlled, multicentre study to demonstrate the efficacy of GlaxoSmithKline (GSK) Biologicals’ 10-valent...
Medical condition: Three dose primary vaccination of healthy infants between 6-16 weeks of age at the time of the first vaccination, followed by a booster dose at 15-18 months.
Full Title: A phase IIIb, open, randomized, controlled, multicenter study to assess the co-administration of Rotarix (GlaxoSmithKline Biologicals’) with Hib-MenCY-TT (GlaxoSmithKline Biologicals’ Meningococcal...
Medical condition: invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C (MenC) and Y (MenY)
Full Title: An international, multicenter, open-label, one-arm study in 150 infants vaccinated with a 3-dose primary series of the DTaP-IPV-Hep B-PRP-T combined vaccine in the Russian Federation and Poland.
Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus in...
Full Title: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients with Metastatic Colorectal Cancer
Medical condition: Metastatic colorectal cancer
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
100000004864
10052362
Metastatic colorectal cancer
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:FR(Trial now transitioned)ES(Ongoing)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2011-004431-31
Sponsor Protocol Number: A3L04
Start Date*: 2012-04-10
Sponsor Name:Sanofi Pasteur SA
Full Title: Phase III, randomized, blind-observer, multi-center, four-arm, parallel-group trial in 2133 infants
Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus i...
Full Title: Randomized multicenter open label trial comparing the efficacy and safety of 48 versus 72 weeks of Peginterferon-alfa-2a plus daily Ribavirin and Amantadinsulfat in patients with chronic Hepatitis ...
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