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
44300
clinical trials with a EudraCT protocol, of which
7354
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 Phase IV, observer-blind, randomised, cross-over, placebo-controlled, multicentre study to assess the immunogenicity and safety of a single dose of Boostrix? in pregnant women.
Medical condition: Booster immunisation against diphtheria, tetanus and pertussis diseases. The study population for this study will include pregnant women.
Disease:
Version
SOC Term
Classification Code
Term
Level
18.0
100000004862
10047976
Whooping cough due to bordetella pertussis (B. pertussis)
Full Title: A randomised, controlled, double blind study of the immunogenicity and safety of Pediacel™, a combined diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and Haemoph...
Medical condition: PEDIACEL® is a fully liquid combination vaccine indicated for infants from 2 months of age to protect against diseases caused by 5 common pathogens: Haemophilus influenzae type b, Corynebacterium d...
Full Title: A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency
Medical condition: Primary Immunodeficiency (PI) diseases
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10021428 - Immune system disorders
10061598
Immunodeficiency
PT
20.0
10021428 - Immune system disorders
10045792
Unspecified disorder of immune mechanism
LLT
20.0
10010331 - Congenital, familial and genetic disorders
10064859
Primary immunodeficiency syndrome
PT
Population Age: Children, Adolescents, Under 18, Adults, Elderly
Full Title: A phase III, open, randomised, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellu...
Medical condition: Healthy volunteers (Immunisation against diphtheria, tetanus and pertussis)
Full Title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10, and 14 Weeks of Age in Infants in India Who Previously Received a Dose of Hepatitis B Vaccine at ...
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: Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects with Primary Immunodeficiency Diseases
Medical condition: Primary Immunodeficiency Diseases (PID)
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: 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 CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
Medical condition: Primary Immunodeficiency Diseases
Disease:
Version
SOC Term
Classification Code
Term
Level
16.1
10010331 - Congenital, familial and genetic disorders
10064859
Primary immunodeficiency syndrome
PT
Population Age: Children, Adolescents, Under 18, Adults, Elderly
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: 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: A phase IIIb, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals dTpa-IPV vaccine (Boostrix Polio) compared with S...
Medical condition: Booster immunisation of healthy preschool children against diphtheria, tetanus, pertussis, poliomyelitis, mumps, measles and rubella; and first or second immunisation of healthy preschool children ...
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 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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