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
44412
clinical trials with a EudraCT protocol, of which
7421
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: Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
Medical condition: Healthy volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellu...
Full Title: Phase III, multi-center study in children fully vaccinated with a three-dose primary and the booster dose of the DTaP-IPV-Hep B-PRP-T combined vaccine or CombAct-Hib™ and OPV and Engerix™ B in Stud...
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: Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) versus sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given simultaneously at separate sites...
Medical condition: Healthy volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellu...
Full Title: Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given as a booster dose at 4 to 6 years of life in children previously vaccinated with PENTAXIM™ in the stud...
Medical condition: Healthy volunteers: indicated for primary vaccination in infants for active immunization against diphtheria, tetanus, pertussis and poliomyelitis.
Full Title: Immunogenicity and safety of Sanofi Pasteur’s DTaP-IPV combined vaccine (TETRAXIM™) given as a three-dose primary vaccination in South Korean healthy infants, as compared to commercially available ...
Medical condition: Healthy volunteers: indicated for primary vaccination in infants for active immunization against diphtheria, tetanus, pertussis and poliomyelitis.
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: RANDOMISED, CONTROLLED CLINICAL STUDY REGARDING THE FEASIBILITY OF
CONVERTING OPIATE DEPENDENTS FROM METHADONE SUBSTITUTES TO SLOW
RELEASE MORPHINE SULPHATE (SEVRE-LONG®)
Medical condition: Patients with an opioid or multiple substance dependence (including opioids), actually enrolled in a methadone maintenance therapy in one of the study centres (ICD classifications F11.22, F19.22).
Full Title: Randomized, open, controlled, multicenter, Phase III trial in infants who will receive DTaP-IPV-Hep B-PRP-T (Group 1, N=286), CombAct-Hib™ and Engerix B™ Pediatric with OPV (Group 2, N=286), or DTa...
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: Phase III, open-label, multi-center booster vaccination study in toddlers who completed a three-dose primary series of the DTaP-IPV-Hep B-PRP-T combined vaccine or Infanrix hexa™ in Study A3L11.
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: 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: Immunogenicity and Safety of the Aventis Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 2, 4 and 6 Months of Age and Followed by a Booster Dose a...
Medical condition: Healty volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellul...
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...
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: Phase III, A3L24 extension protocol, randomized, blind-observer, multi-center booster vaccination study in toddlers who completed a three-dose primary series of DTaP-IPV-Hep B-PRP-T combined vaccin...
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: 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: Phase III, open-label, and mono-center booster vaccination study in toddlers who completed a three-dose primary series of DTaP-IPV-Hep B-PRP-T combined vaccine or of Pentaxim™ and Engerix™ B in Stu...
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: Immunogenicity and Safety of the Aventis Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™), Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dos...
Medical condition: Healty volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellul...
Full Title: Immunogenicity and Safety of Sanofi Pasteur’s DTaP IPV HB PRP~T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Month...
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: Phase III, randomized, blind-observer, multicenter, four-arm study of three batches of the DTaP-IPV-Hep B-PRP-T vaccine and one arm receiving Infanrix hexa™.
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...
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